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1st PDA Europe Annual Meeting
The Parenteral Drug Association presents:
T H E F U T U R E I N I N J E C T A B L E S
2016
27 June - 1 July 2016 Estrel Hotel Berlin
Berlin | Germany
Gold SponsorPlatinum Sponsor
M E E T I N G G U I D ERoundtables | Conference | Exhibition | Education Program
#pdaeuannual
Silver Sponsor Media Partner
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WELCOME FROM THE CHAIR
Dear Friends, Colleagues, Collaborators and Peers,
Welcome to Berlin and PDA Europe’s first Annual Meeting The Future in Injectables!
This meeting was carefully developed to provide you with a first-hand opportunity to stay current and anticipate future advances in modern sterile manufacturing and quality oversight. The Scientific Program Planning Committee has worked hard to offer you a very unique program with new and exciting topics specifically aimed at reflecting innovative approaches and cutting edge technologies.
Renowned industry leaders and international regulators will share their experience with you in daily plenary sessions and a series of parallel tracks. The opening plenary session will focus on strategies developed by partakers in healthcare to strive in the context of globalization and rapid scientific innovation. Concurrent sessions are designed to address many of the current challenges our industry and regulators faces. They will feature over thirty presentations with practical examples and case studies, and offer the perfect blend of industry updates, educational topics, technical advances and trends in regulatory oversight. We will dive deeply into continuous manufacturing, flexible facilities, modern analytical technologies, automation and robotics, blow-fill-seal technology, big data processing and ‘industry 4.0’, serialization and product tracking implementation, data integrity, innovative injection devices, and – last but not least – the related regulatory aspects. The conference will conclude with an outlook to the future of our industry, covering facilities, manufacturing and therapies of the future in a global context.
Opportunities to interact with speakers, industry peers, regulators, exhibitors and PDA leadership will be plenty. They include extended networking breaks, interactive roundtable discussions with PDA chapters from Europe and Japan and a very special European networking reception on the evening of June 28th.
As an extended offer, on June 30th and July 1st PDA Europe will be hosting several in-depth training courses that are designed to complement topics presented at the conference.
PDA Europe’s first Annual Meeting The Future of Injectables shows once again PDA’s commitment to bringing manufacturing technology advances to the forefront and facilitating discussions between industry, suppliers and regulators. You will leave the conference richer, both in terms of knowledge and relationships, which will benefit your career and organization.
On behalf of the program planning committee and PDA staff, wish us all a week filled with fruitful discussion and continuous learning through professional interaction and exchange of ideas!
Welcome to Berlin!
Ursula Busse, PhD MBA, Novartis Group Quality Conference Chairwoman
Activities at a Glance 4
Roundtable Discussions 6
Conference 8Networking Event 11
Poster Session 15
Floor Plan 17
Exhibitor Abstracts 18
PDA Education Program 25Test Methods for Pre-filled Systems 26
Cleaning and Disinfection 28
How to Find the Right GMP for APIs 30
Root Cause Investigation for CAPA 32
Development and Manufacturing of Pre-filled Syringes 34
Information 38PDA Social Media Guide 39
Table of Contents
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ACTIVITIES AT A GLANCE
Tuesday, 28 June8:00 - 18:00Registration Hours
9:00 - 18:30Conference Day 1 3 Tracks A, B, C
Rooms A, B, C
14:00 - 16:00EU Exhibition Committee Meeting (by invitation only)
Room 30241
19:00 - 22:30PDA Europe Networking Event "Summer in Berlin" Pier 13 Restaurant & Bar, Tempelhofer Damm 227, 12099 Berlin
Meeting Point for Bus Shuttle: Hotel Estrel - PDA Registration Desk
Thursday, 30 June7:30 - 12:00Registration Hours Education & Training
9:00 - 17:30How to Find the Right GMP for APIs One-Day Training Course
Room 30212
9:00 - 18:00Root Cause Investigation Training Course, Day 1
Room 30241
9:00 - 17:45Development and Manufacturing of Pre-filled Syringes Workshop, Day 1
Room Paris
13:00 - 14:00Open House PDA Europe Office Visit Am Borsigturm 60 13507 Berlin (by invitation only)
9:00 - 17:00Test Methods for Pre-filled Syringe Systems One-Day Training Course
Room Lyon
9:00 - 18:00Cleaning and Disinfection One-Day Training CourseRoom 30210
Wednesday, 29 June8:00 - 17:00Registration Hours
8:00 - 9:00Morning Roundtables PDA Chapters Italy, France, UK
Room A
7:00 - 8:00Orientation Breakfast (by invitation only)
Room Paris
8:00 - 9:00Morning Roundtables PDA Chapters Ireland, Israel, Japan
Room B
9:00 - 17:30Conference Day 2 3 Tracks A, B, C
Rooms A, B, C
8:00 - 9:00Interest Group Meeting TechTransfer
Room C
Monday, 27 June8:00 - 17:00Exhibition Set-up
8:00 - 18:00Registration Hours
13:30 - 15:30Roundtable Discussion Business Opportunities India
Room 30241
16:00 - 18:00Roundtable Discussion Business Opportunities Iran
Room 30241
17:00 - 18:00Chapter Council Meeting (by invitation only)
Room Paris
18:00 - 20:00Welcome Reception “Willkommen” to Berlin
Biergarten - Terrace by the river Spree
Friday, 1 July8:00 - 12:00Registration Hours Education & Training
9:00 - 16:30Root Cause Investigation Training Course, Day 2
Room 30241
8:30 - 16:45Development and Manufacturing of Pre-filled Syringes Workshop, Day 2
Room Paris
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1 Ursula Busse, Conference Chair, Novartis
2 Jette Christensen, Novo Nordisk
3 Véronique Davoust, Pfizer
4 Derek Duncan, LIGHTHOUSE
5 Gabriele Gori, GSK Vaccines
6 Eric Meier, Novartis
7 Stephan Rönninger, Amgen
8 Mihaela Simianu, Consultant
9 Ryan Smith, SightMachine
10 Jochen Strube, Clausthal University of Technology
11 Sylvia Becker, PDA Europe
12 Georg Roessling, PDA Europe
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S C I E N T I F I C P R O G R A M P L A N N I N G C O M M I T T E E
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altran.de
Competences Quality & Regulatory Compliance
Process Engineering
Smart Manufacturing
Life Science Digitalisation
Innovative Medical Solution Development
Your end-to-end partner
for Industrial Performance
and Compliance in
LIFE SCIENCES
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ROUNDTABLE DISCUSSIONS
Monday, 27 June
Room 30341
Business Opportunities India Moderator: Georg Roessling, PDA Europe
13:30 Indo-German Economic Relations: Missed Opportunities Sushil Khanna, University Calcutta, Visiting Professor in Leipzig
Business Opportunities India Joerg Strassburger, Go East, Advisors for Emerging Markets
Yvonne Metzger, Bundesverband mittelständische Wirtschaft - The German Association for Small and Medium-sized Businesses
Q&A, Discussion with Exhibitors and Conference Participants
15:30 End of Business Opportunities India
Business Opportunities India
Business Opportunities IranRoom 30341
Business Opportunities Iran Moderator: Georg Roessling, PDA Europe
16:00 Please join the roundtable discussion on the current situation of the pharmaceutical industry in Iran. Topics of discussion will be:
• Regulatory Environment of the Iranian Pharmaceutical Industry
• Modernisation Needs of the Pharmaceutical Industry
Akbar Abdollahiasl, General Director of Pharmaceutical Affairs, Ministry of Health, Iranian FDA
Zohre Bazaz, Inspector, Iranian FDA
Q&A, Discussion with Exhibitors and Conference Participants
18:00 End of Business Opportunities Iran
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ROUNDTABLE DISCUSSIONS
Business Opportunities Iran
Business Opportunities IndiaYvonne Julia Metzger, CEO, markets and more
Yvonne Julia Metzger, M.A., is founder and CEO of markets and more, General Manager BVMW India and official representative of BVMW e.V. (Bundesverband für mittelständische Wirtschaft) in the metropolitan region Hamburg. As CEO of markets and more, she works for several companies as Sales Manager, CRM and Marketing Manager, speaker and trainer. markets and more is specialized in developing and implementing marketing strategies and finding sales partners for companies in Germany, Europe and India with focus on biotech, medical and pharma industry. Yvonne Julia Metzger has more than ten years of international experience in marketing, sales and event
management. She has built up and guided the department for sales and marketing at one of the leading laser fiber manufacturers in Germany. Prior to that, she worked as project manager at the German-Dutch Chamber of Commerce in The Hague and in a market research company.
Joerg Strassburger, CEO, Go East Advisors
Dr. Joerg Strassburger is the Founder and CEO of Go East Advisors. With offices in Germany and India, the company is supporting Europe-an chemical companies in their business development in Asia with a strong focus on the Indian market. Besides strategy development and strategy implementation to achieve stronger business growth in India, he and his partner identified India as an attractive sourcing market for chemical intermediates. Purchasing services range from spot purchasing of mineral fillers to the establishment of contract manufacturing agreements for pharmaceutical intermediates. Go East Advisors’ business portfolio also includes identifying the right
partners to establish long-term partnerships, JV’s or Acquisitions between Indian and European chemical companies. Before founding Go East Advisors, Dr. Strassburger was the Country Representative and Managing Director of LANXESS India Private Limited from 2005 to 2014. He was responsible for the oper-ations and development of LANXESS' business units in India. Before this assignment, Dr. Strassburger was head of Corporate Development at LANXESS AG, and was actively involved in developing LANXESS' global strategy.
Akbar Abdollahiasl, General Director of Pharmaceutical Affairs, Ministry of Health, Iran
Dr. Abdollahiasl is General Director of Pharmaceutical Affairs in Iran's Ministry of Health and assistant professor in Tehran University of Medical Sciences. He is a pharmacist and PhD of Pharmacoeconomics and Pharmaceutical Administration. While working in the phar-maceutical fields, he’s had the responsibility of management of medicinal supply chain, medical and pharmaceutical data analysis, pricing of pharmaceutical products and planning of NRA systems as well as the Head of Statistic and Planning Office in Iran Food & Drug administration. He has directed more than 20 research projects trying to find a system dynamics model for national drug policy and on
subjects such as Iran medicine’s prices, availability, affordability and price components (in corporation with HAI), essential medicines and pharmaceutical policies unit, pharmaceutical education in Iran and cost of different illnesses in Iran. He’s participated in some courses like Health Sector Reform course offered by American University of Beirut (2003-2004), Pricing and Reimbursement course offered by Vienna School of Clinical Researches (2005) and some MIS and data mining courses. He is one of the key opinion leaders of pharmaceutical fields in Iran.
Speaker Biographies
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CONFERENCE AGENDA
Tuesday, 28 June
9:00 Welcome: Opening Remarks, Introduction & PDA Awards Georg Roessling, PDA Europe Ursula Busse, Novartis, Conference Chair
Opening Plenary Moderator: Ursula Busse, Novartis
9:15 The Quality Journey: From Good to Great Martin van Trieste, Amgen
9:45 A Question of Trust – Hard Won, Easily Lost John Johnson, NSF Health Sciences
10:15 Overcoming the Divide of Excellence & Quality Thomas Friedli, University of St. Gallen
10:45 Coffee Break, Poster Session & Exhibition
11:15 Regulatory Considerations for Continuous Manufacturing: EU Perspective
Jean-Louis Robert, European Medicines Agency, Chair of the CHMP/CVMP Quality Working Party
11:45 The International Role of PIC and PIC/S in Harmonizing Inspections Paul Hargreaves, MHRA, PIC/S
12:15 Q&A, Discussion
12:45 Lunch Break, Poster Session & Exhibition
13:40 Transition to Parallel Tracks
P A R A L L E L T R A C K S
Rooms A B C
TRACK A TRACK B TRACK CSession 1 Continuous Manufacturing
& Flexible Facilities TestingLifecycle Management
and Innovation:Are they Mutually Exclusive?
The Future in InjectablesDigital Version
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CONFERENCE AGENDA
Moderators: Mihaela Simianu, Consultant Jette Christensen, Novo Nordisk Ursula Busse, Novartis
Session 1 Continuous Manufacturing& Flexible Facilities Testing
Lifecycle Management and Innovation:
Are they Mutually Exclusive?
13:45 Concepts and Solutions for Continuous Manufacturing
Eric Meier, Novartis
Attribute Focus to Achieve the Quality Target Product Profile (QTPP)
Rohini Deshpande, Amgen
Challenges of Pharma Industry with Lifecycle Approach
Anders Vinther, Sanofi Pasteur
14:15 Process Development and Engineering Challenges for Future Manufacturing of Biologics
Jochen Strube, Clausthal University
Post Approval Lifecycle Manage-ment of Analytical Control Systems
Emma Ramnarine, Genentech / Roche
From QbD to Lifecycle Management: Regulatory Perspective of Guide-lines that should Encourage Innovation - Opportunities and Challenges
Jean-Louis Robert, European Medicines Agency, Chair of the CHMP/CVMP Quality Working Party
14:45 Traceability in Continuous Manufacturing
Jochen Thies, Glatt Group
All-in-One Solution for Parenteral Containers CCI Testing and Headspace Gas Verification
Andrea Simonetti, Bonfiglioli Engineering
Recent Initiatives put Forward by the WHO to Facilitate Post-Approval Change Management for Vaccines
DianLiang Lei, World Health Organization
15:15 Q&A, Discussion Q&A, Discussion Q&A, Discussion
15:45 Coffee Break, Poster Session & Exhibition
P A R A L L E L T R A C K S
Rooms A B C
TRACK A TRACK B TRACK CSession 2 Automation & Robotics Testing Blow-Fill-Seal
Moderators: Masahiro Akimoto, Otsuka Pharm. FactoryStephan Rönninger, Amgen
Jette Christensen, Novo Nordisk Georg Roessling, PDA Europe
16:15 Nanoparticle Technology in Pharmaceutical Applications
Sanshiro Nagare, Nara Machinery
Testing of Final Product during Scale Up: Lessons Learned
Derek Duncan, LIGHTHOUSE
Pre-filled Syringes made by Blow-Fill-Seal
Rajeev Kabbur, Brevetti Angela
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CONFERENCE AGENDA
Session 2 Automation & Robotics Testing Blow-Fill-Seal
Moderators: Masahiro Akimoto, Otsuka Pharm. FactoryStephan Rönninger, Amgen
Jette Christensen, Novo Nordisk Georg Roessling, PDA Europe
16:45 A New Generation Packaging Line for Filled Product in Carton with Integrated Dividers
Hiroaki Mizuno, Omori Machinery
CCIT Technology on BFS Containers: From the High Speed Testing Prospective, the Testing Reliability and the Validation Approach
Jaime Cobo, Wilco
Basic Principles and Regulatory Requirements for BFS Technology including Qualifications and Validation Aspects
Christoph Bohn, Holopack Packaging Technology
17:15 Overview of the Low Voltage Electron Beam Sterilization System and its Benefits
Koji Kawasaki, AirEX
In-Line Automated Visual Particle Inspection of BFS Containers for Injectable Drug Products
Heino Prinz, rommelag
Specific Aspects for Manufacturing and Autoclaving of BFS Products
Martin Haerer, Holopack Packaging Technology
17:45 Moderator:Masahiro Akimoto, Otsuka Pharm. Factory
Roundtable DiscussionBusiness Opportunities Japan
Session Speakers
Moderator:Gabriele Gori, GSK Vaccines
Roundtable Discussion Final Product Control:CCIT & Visual Inspection– Do we need it? What will Annex 1 bring?
Session Speakers
Experience with Filling of Biological Products with Cool BFS Technology
Otto Schubert, Maropack
18:30 End of Day 1
19:00 Joint Departure & Networking Event @ Pier13
Summer in BerlinNetworking Event
The Parenteral Drug Association presents:
Meeting Point: Hotel Estrel - PDA Registration Desk
Shuttle Bus leaving at 19:00hShuttle Bus returning to the Estrel Hotel 22:30hDress Code: Casual Summer Look
Please confirm your attendance at the PDA Registration Desk. If you have any dietary requirements, please let us know.
Pier 13 | Tempelhofer Damm 227 | Tempelhofer Hafen | 12099 Berlin
SPECIAL ACT:
HEAR THE FIRST PDA BAND PLAYING.
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CONFERENCE AGENDA
Wednesday, 29 June
7:30 Welcome Coffee
M O R N I N G R O U N D T A B L E S
8:00 MEET THE PDA CHAPTERS
PDA has 24 Chapters around the world with local programs and resources to help you stay informed, interact with your peers, and facilitate exchange with the pharmaceutical and biopharmaceutical industry. Meet six of these chapters in this morning session and get to know the chapter presidents and industry peers in your region!
ROOM A ROOM B
ITALY / SWITZERLAND FRANCE UK IRELAND ISRAEL JAPAN
I N T E R E S T G R O U P M E E T I N G , T E C H T R A N S F E R ( T T I G )
8:00Room C
• Scope and Activities• Technical Report #65• TT IG current picture
- Membership, Geographic distribution, Expertise onboard
• Goals for 2016 & Next steps• Q&A, Discussion
IG Leader:Mirko Gabriele, Patheon
P A R A L L E L T R A C K S
Rooms A B C
TRACK A TRACK B TRACK CSession 3 Big Data Processing / Industry 4.0 Regulatory Track Technical Track
Moderators: Georg Roessling, PDA Europe Jette Christensen, Novo Nordisk Mihaela Simianu, Consultant
9:10 Industry 4.0 - Readiness for Pharmaceutical Companies
Andreas Traube, IPA Fraunhofer Institute
What an Inspector Needs to Know About Assessment
Kevin O’Donnell, Health Products Regulatory Authority, Ireland (HPRA)
Serialization Requirements in Europe
Véronique Davoust, Pfizer
9:40 Industry 4.0: How to Identify and Use Key Enabling Technologies – Demonstration by Case Studies
Francisco Jose Herrador Jorro, Altran
Challenges in Pharmaceutical Industry-SME Perspective
Andreas Sachse, CPL SACHSE
Serialization and Product Tracking Implementation in a Global Environment
Michael Ritter, Novartis
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CONFERENCE AGENDA
Session 3 Big Data Processing / Industry 4.0 Regulatory Track Technical Track
10:10 Manufacturing & Big Data: Approaches for Pharma
Toni Manzano & Pep Gubau, BigFinite
Import of Pharmaceutical Products: Annex 21, OECD Guideline
Stephan Rönninger, Amgen
Track and Trace Implementation in Iran
Akbar Abdollahiasl, IFDA
10:40 Q&A, Discussion Q&A, Discussion Q&A, Discussion
10:55 Coffee Break, Poster Session & Exhibition
11:25 Transition to Parallel Tracks
P A R A L L E L T R A C K S
Rooms A B C
TRACK A TRACK B TRACK CSession 4 Modern Analytical Techniques Data Integrity Drug Administration
Moderators: Derek Duncan, LIGHTHOUSE Stephan Rönninger, Amgen Eric Meier, Novartis
11:30 Predictive Modelling and Real-time Analytics Applied to Fill and Finish Operations
Cenk Undey, Amgen
DI – A Criminal Act? Overview, Clarification, Definition
Anil Sawant, Merck & Co.
Innovative Drug Delivery
Ian Thompson, Ypsomed Delivery Systems
12:00 Digital Transformation for Biotech-nology: A Big Data Approach to Manufacturing Analytics
Ryan Smith, SightMachine
Data Integrity for Computer Systems – A Bumpy Road to Compliance
Wolfgang Schumacher, Roche
Smart Medication–Where Electronics meet Drug Delivery
Markus Bauss, SHL Connect
12:30 Automated Media Fill Inspection
David Brueckner, Roche
Data Integrity – A Holistic Approach
Madlene Dole, Novartis
Best Practice in Glass Handling During Device Development and Commercialization
Thomas Schoenknecht, SHL Medical
13:00 Q&A, Discussion Q&A, Discussion Q&A, Discussion
13:15 Lunch Break, Poster Session & Exhibition
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CONFERENCE AGENDA
Session 5 : Closing Plenary - Future Developments Moderator: Ursula Busse, Novartis
14:15 Past & Future of Injectable Dosage Forms for Biologics – Quo vadis, Parenteralia?
Hanns-Christian Mahler, LONZA
14:45 Needs and Possibilities of New Manufacturing and Facility Design Maik Jornitz, G-Con Manufacturing
15:15 Requirements and Opportunities for the “Parenteral Facility of the Future”
Morten Munk, NNE Pharmaplan
15:45 Coffee Break, Poster Session & Exhibition
16:15 Challenges for Medical Treatment in Future Samvel Azatyan, World Health Organization
16:45 Panel Discussion: The Future of Injectables
In this panel discussion, we want to focus on the future of manufacturing, application of injectables and regulatory aspects.
Some of the questions to be discussed are:• How innovative is the pharmaceutical industry?
• What are hurdles for innovation and what can contributions from technology and regulatory bodies be?
• How will new application concepts help patients?
• Will the future see one global dossier and one harmonized inspection system?
• What can ICH, WHO and PIC / S contribute?
Participants:Samvel Azatyan, World Health Organization
Paul Hargreaves, MHRA and Chair of PIC / S
Steven Lynn, Novartis (and former FDA)
Hanns-Christian Mahler, Lonza
Martin van Trieste, Amgen
17:30 Closing Remarks, End of Conference & Farewell Coffee
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During all coffee and lunch breaks, you have the opportunity to visit the Poster Session located in the Exhibition Area.
Poster presenters will be happy to welcome you and answer your questions.
Shlomo Sackstein, Biopuremax
Biopuremax- Pre-Treatment Water System
Róbert Lehocky, University of Chemistry and Technology, Prague
Enzymatic dissolution method for poorly soluble API in injectables depot administration
Daniel Pěček, Zentiva
Ball Milling Preparation of Sustained Release Suspension for Intramuscular Administration
Danilo Maruccia, PQE
Data Integrity Challenge:The Infrastructure Technology Lifebelt
Paul Lopolito, STERIS Corporation
A Scientific Approach to Maintaining your Stainless Steel Surfaces
POSTER SESSION
Elizabeth Rivera, STERIS Corporation
Cleaning Validation Concerns for Continuous Manufacturing
Christa Jansen-Otten, West Pharmaceutical Services
Component Selection Strategies for PFS: Risk Mitigation, Performance and Larger Injection Volume Driving Innovative Solutions
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Global Pharmaceutical Solutions
Sensitive biopharmaceuticals? We take the challenge
• Drug delivery solutions & technologies for injection and infusion
• Expert platforms in pharmaceuticals, polymers, coatings, precision and miniaturization technologies
• Uncompromised Quality and Regulatory Affairs support
• Committed to improved drug delivery and patient comfort
Ad_Plajex_white_A4_2015_0910.indd 1 10/09/15 16:42
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PDA Registration
Exhibition Stand
C: Chapter Stand
Platinum Sponsor
Gold Sponsor
Silver Sponsor
Buffet / Coffee Station
Poster Session
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Exhibitor Booth
Nara Machinery 1
Saint-Gobain 2
Veltek Associates 3
Groninger 4
Steris 5
Toxikon 6
Iwata Label 7
Novatek 8
Azbil Telstar 9
West Pharmaceutical Services 10
LIGHTHOUSE Instruments 11
Gateway Analytical 12
rap.ID 13
Altran 14
Bonfiglioli Engineering 17
Merck 19
Afton Scientific 20
NSF Pharma Biotech 21
Terumo 22
Wilco 23
PTI Inspection Systems 25
PQE 26
Watson-Marlow 27
OMORI Machinery 28
OMPI 29
biopuremax 31
Malvern Instruments 32
rommelag 37
PDA Country Chapter Booth
Italy Chapter C1
France Chapter C5
United Kingdom Chapter C3
Ireland Chapter C4
Israel Chapter C2
Japan Chapter C6
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Afton Scientific 2020 Avon Court Charlottesville 22902, VA United States Tel: +1 434 97 93 73 7 Fax: +1 434 97 93 73 8 info@aftonscientific.com www.aftonscientific.com
cGMP Processing of Sterile Products Afton Scientific
Afton is a cGMP sterile processor of pre-packaged empty sterile vials, stoppers and seals (Ready-to-Fill) to companies worldwide for im-mediate use in cGMP aseptic filling operations. These components are used not only for small clinical fills, but also for approved mar-keted injectable drugs. Afton is inspected by both the US FDA and MHRA. Aftonís customers include small biotechs, multinational phar-maceutical companies and major research institutions. Afton ships worldwide. Afton also provides cGMP contract sterile filling services of investigative new drugs, biologics and commercial injectable pharmaceuticals.
Altran Deutschland S.A.S. & Co. KG Frankfurter Ring 81 80807 - Munich Germany P: +49 89 930 800 F: +49 89 930 139 ML-DE-info@altran.com www.altran.com
With a network of 2,000 dedicated consultants in more than 15 countries, Altran delivers the highest level of expertise to over 200 customers to develop innovative medical solutions, improve their operational performance and compliance and accelerate their dig-ital transformation. Ageing population, chronic/lifestyle diseases, emerging market expansion, treatment and technology advances, together with important efforts to optimize healthcare spending, outcomes and delivery are megatrends influencing companies op-erating in the Life Sciences industry. With over 30 years of experience in Life Sciences, Altran provides adapted strategic, operational and technological innovative services and solutions to support compa-nies in all stages of the medical-product life cycle and help them address cost and regulatory pressures, growing needs for modern technologies integration across the whole value chain and a shift to outcome-based business models.
Azbil Telstar United Kingdom Unit 4, Shaw Cross Business Park Horace Waller VC Parade Dewsbury West Yorkshire WF12 7RF United Kingdom T: 44 1924 455339 0 www.telstar.eu
Engineering, construction, consulting and validation services and design, manufacture and sales of integrated process equipment solutions with in-house sterilization, freeze-drying, containment, barrier systems, production of PW, WFI, clean steam, clean air tech-nologies and automated systems for Life and Health Sciences; inte-grating knowledge and technologies to provide optimal solutions with a high added value to our customers for the pharmaceutical, biotechnology and veterinary industries and research centers.
Biopuremax HaSadnaot 4 st 46728 - Herzliya Israel P: +972 9 9716111 F: +972 9 9716112 Shlomo@biopuremax.com www.biopuremax.com
The Biopuremax is a new type of pretreatment water system for RO with no organic resins for softening, no carbon and no SBS for chlo-rine destruction. The system based on electrical scale precipitation and UV destruction of chlorine. All the system is hot water sanitized (full SS construction) It has no backwash, no regeneration and no chemical dosing. The system is revolutionary in the fact that it has no moving parts, no regenerations, no chemicals, no contamination and no waste stream. The system is reliable as it is simple, no tuning or adjustments are needed after the design and installation.
EXHIBITOR ABSTRACTS
2016 PDA Europe
Pharmaceutical Freeze Drying Technology27-28 September 2016 Strasbourg | France
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Bonfiglioli Engineering S.r.l. Via Rondona, 33 44049 Vigarano Pieve (Ferrara) Italy Tel: +39 0532 71 56 31 Fax: +39 0532 71 56 25 marketing@bonfiglioliengineering.com www.bonfiglioliengineering.com
Bonfiglioli Engineering, leader in manufacture of inspection equip-ments, has developed an advanced expertise in Container Closure Integrity Testing, Visual Inspection and Headspace Gas Analysis context, addressing both quality and safety of all container sys-tems, for Laboratory and Inline container integrity testing for lab-oratories as well as in-line container integrity testing. After over 40 years of planning and manufacturing innovation, BE prides itself on a perfect combination of production stability, testing efficiency and maintenance simplicity. The machines, custom-made to customers specifications with top quality standards and proven technologies, are built to be used in all production conditions and designed to be easily managed through intuitive interface boards and fast format changes. BE’s innovative machines are cost, time and space-effec-tive. They guarantee high quality, safe products to the end-user while protecting manufacturers from financial loss due to recalls, lawsuits and potential adverse publicity.
Gateway Analytical 5316 William Flynn Highway 15044 - Gibsonia United States P: +1 724 443 1900 F: +1 866 658-1445 lehrp@gatewayanalytical.com www.gatewayanalytical.com
Gateway Analytical is a contract analytical laboratory and consult-ing company offering the pharmaceutical, materials science and forensics industries expertise by using conventional and innovative analytical testing techniques. Gateway Analytical is FDA registered, cGMP complaint, DEA licensed, and ISO 17025 certified. We ensure that all testing is performed to provide results efficiently and effec-tively, while maintaining the highest quality standards. Gateway An-alytical is a subsidiary of ChemImage Corporation, a leader in chem-ical imaging technology and instrumentation.
groninger & co. gmbh Hofaeckerstrasse 9 74564 - Crailsheim Germany P: +49 7951 495 0 F: +49 7951 495 3138 info@groninger.de www.groninger.de
Filling and packaging machines for the pharmaceutical, consum-er healthcare and cosmetic industry. groninger is a successful, ex-perienced and dynamic company with around 1000 employees worldwide, focused on developing and manufacturing specialized machines for accurate filling and secure closing of liquid pharmaceu-tical products, especially in pre-sterilized syringes, vials and bottles. Working close with the customer, groninger develops and realizes the optimal solution for the customers' requirements! The groninger machine program ranges from: fully automated syringe processing lines with tray loading / unloading, washing, filling, gassing, piston rod insertion, checking, labeling as well as label control ñ speeds up to 60.000/h; liquid filling lines for vials and bottles including washing station, sterilization tunnel, filling, stoppering, labeling, label control as well as capping ñ speeds up to 48.000/h; eye drop filling and clos-ing lines with the latest technology and speeds up to 24.000/h; highly flexible filling and closing lines for consumer healthcare, diagnostics and other non-aseptic liquid products in plastic and glass contain-ers; isolator compatible filling machines; peripheral equipment for filling and closing lines, including container and component sorting and feeding equipment and robotic sorting and feeding solutions.
IWATA LABEL Europe Königsallee 92a 40212 - Düsseldorf Germany P: +49 211 5403 9784 toshiaki_kurihara@iwatalabel.co.jp www.iwatalabel.com
IWATA LABEL Europe GmbH is a specialty manufacturer of adhesive labels and labeling machines for pharmaceutical products. Our products add high value and multiple functions to pharmaceutical labeling needs. The need for labeling solutions, which protect medi-cal staff, greatly helps us focus on innovation and develop new prod-ucts and services.
EXHIBITOR ABSTRACTS
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LIGHTHOUSE Instruments Science Park 408 1098 XH Amsterdam The Netherlands P:+31 6 4226 7380 euinfo@lighthouseinstruments.com www.lighthouseinstruments.com
LIGHTHOUSE is the leading global provider of laser-based head-space analysis systems. Headspace applications include: 100% container closure integrity (CCI) inspection, off-line CCI testing, IPC of headspace oxygen during filling and for stability studies, lyo cy-cle optimization, lyo chamber moisture mapping, and automated media fill inspection. LIGHTHOUSE offers a range of benchtop and in-line platforms with patented laser sensor technology commer-cialized with the help of funding from the Food and Drug Adminis-tration. In addition, analytical services are delivered from laboratory facilities in Amsterdam and Charlottesville, Virginia.
Malvern Instruments Enigma Business Park, Grovewood Road Malvern WR14 1XZ Worcestershire United Kingdom Phone: +44(0) 1684 892456 Fax: +44 (0) 1684 892789 stephane.rouquette@malvern.com www.malvern.com
Malvern Instruments proposes a full range of instruments to charac-terize proteins and macromolecules:• Zetasizer, DLS & SLS for size, molecular weight, protein charge; • NanoSight NTA, concentration; • OmniSEC, molecular weight/structure;• MicroCal, binding parameters; • Viscosizer, size and viscosity.
For Visible and Sub visible particles:• The Morphologi G3ID:
An automatic microscope platform associated with Raman Spec-trometer to measure concentration, size, shape and chemical ID of particles from 1 to 1000 µm.• The Archimedes:
RMM (Resonant Mass Measurement) technique, to measure mass, concentration and buoyancy (protein versus silicon oil) of protein formulations from 0.2 to 5 µm.
Merck Frankfurter Strafle 250 64293 Darmstadt Germany Tel.: +49 (0) 6151 72-0 Fax: +49 (0) 6151 72-2000 service@merckgroup.com www.merckgroup.com
Merck a leading science and technology company in life science, offers products used by pharmaceutical and biotechnology com-panies to develop and manufacture drugs safely and efficiently. We provide excipients, APIs, complex API manufacturing services and critical raw materials to support all stages of the drug manufactur-ing process from research to industrial-scale production and quality control. Our products meet the highest purity standards with exten-sive documentation and services to assure regulatory compliance.
NARA Machinery Co., Ltd. Europaallee 46 50226 - Frechen Germany P: +49 2234 2776 0 F: +49 2234 2306 7 contact@nara-e.de www.nara-e.de
For more than 90 years supporting companies from various indus-tries all over the world with solving their challenges in matters of powder treatment. Specialized in drying, milling, mixing and particle design we believe to provide our customers and partners the best know-how to meet their expectations.
Novatek International 2537 Rue Guenette H4R 2E9 Montreal Canada P: 1-514-668-2835 F: : 1-336-6537 sales@ntint.com www.ntint.com
Novatek is regulatory compliant software provides the building blocks for a complete quality management solution that can be tailored to any clientís needs. Our software can be used as stand-alone modules or integrated with other modules to form large-scale comprehensive solutions. With 20 years of successful installations worldwide, Novatek has developed an extensive base of regulatory knowledge ensuring compliance and peace of mind during audits for our clientele. Build your solution with the flexibility to grow with your needs and implement at your pace!
EXHIBITOR ABSTRACTS
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NSF Pharma Biotech The Georgian House, 22/24 West End, Kirkbymoorside York, YO62 6AF United Kingdom Tel: +44 1751 43 29 99 Fax: +44 1751 43 24 50 pharmamail@nsf.org www.nsf.org
NSF Health Sciences Pharma Biotech is a major global provider of pharmaceutical education, consultancy, auditing and analytical testing. Our education programs include GMP courses, QP Training, Sterile Manufacture, Human Error Prevention and IRCA certified QMS auditor courses. NSF provides consultancy for GMP/GDP compli-ance, quality management systems and regulatory enforcement ac-tion support. We conduct mock regulatory inspections, supplier au-dits and certification. Our mission is to work in partnership with our clients to add value through • Improving efficiency and operational excellence through simplification of quality systems and processes • Helping companies adopt standards that are fit for purpose through benchmarking • Supporting companies in preparing for future chal-lenges (business and regulatory) to stay ahead of their competition • Educating employees to improve business performance, robustness and flexibility • Guiding companies to change their culture!
Omori Europe Eektestraat 1 7575 AP - Oldenzaal The Netherlands P: +31 541 582026 F: +31 541 520595 info@omorieurope.com www.omori.co.jp
Omori supply a wide range of state-of-the-art stretch and flow wrap-pers (HFFS) for different, creative and innovative packaging. We are a leader in the food and pharmaceutical industries. The packaging machines can be combined with different automated input systems, to provide a turnkey packaging system. The combination of high quality equipment with creative packaging solutions, gives a beau-tiful and luxurious look to your product, with distinctive character. The advanced, Japanese machines of Omori comply with the Euro-pean directives and components can be specified to suit the cus-tomerís requirements.
OMPI Via Molinella 17 35017 - Piombino Dese Italy P:+39 049 9318111 F:+39 049 9366151 info@ompipharma.com www.ompipharma.com
Ompi is the Pharmaceutical Systems division of Stevanato Group. OMPI boasts a unique expertise in providing superior pharmaceu-tical containers from glass tubing. Its comprehensive portfolio cov-ers every customer need, from those related to small molecules to highly sensitive drugs: syringes, pen and dental cartridges, injection and lyophilization vials and ampoules. Syringes, cartridges and vials are produced both in bulk and sterile format (www.ez-fill.com). Ompi EZ-fill concept is a solution that provides the pharmaceutical vials, cartridges or syringes already washed, sterilized ready to be filled by simplifying the traditional production process. Ompi also provides customized containers, all manufactured to the highest standards.
PQE Deutschand GmbH Landshuter Str. 55 85435 - Erding Germany P: +49 8122 17750 60 F: +49 8122 17750 61 de.info@pqe.eu www.pqe.eu
PQE is a Contract Quality Organisation and a Complete Quality Solu-tion provider for GCP, GLP, GMP & GDP areas in the Life Science Indus-try. Since 1998, we have successfully completed more than 10,000 projects world wide and now serve our Clients from offices in Italy, Spain, Germany, Switzerland, US, LATAM, the Middle East and China. As an international company we have experience working in more than 15 languages and have an excellent history of supporting small, medium and large size companies exceed compliance standards from the FDA / EMA / WHO / TGA / SFDA / ANVISA / INVIMA and other local authorities.
EXHIBITOR ABSTRACTS
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PTI Inspection Systems 145 Main Street 10707 - Tuckahoe United States P: +1 914 337 2005 F: +1 914 337 8519 info@ptiusa.com www.ptiusa.com
PTI Inspection Systems is the leading manufacturer of non-destruc-tive package quality inspection technologies for package integrity testing, seal integrity, leak testing and container closure integrity testing (CCIT). PTI technologies include vacuum decay, airborne ul-trasound and high voltage leak detection. Our technologies are de-terministic, quantitative test methods that exclude subjectivity from package testing, and use test methods that conform to ASTM stan-dards. PTI Inspection systems provide repeatable, reliable results and can be used at any point in the manufacturing process as they are non-destructive, non-invasive and require no sample prepara-tion.
rap.ID Particle Systems GmbH Köpenicker Str. 325, Haus 11 12555 Berlin, Germany Tel: +49 30 6576 3440 Fax: +49 30 6576 3441 information@rap-id.com www.rap-id.com
rap.ID creates fully GMP compliant analysis instruments for particu-late identification and has defined the standard in pre-filled syringe lubrication control. rap.ID is the technological leader in the identifi-cation of contamination particles as it is the only company world-wide combining micro Raman and LIBS in one instrument. Using its pharmaceutical industry experience rap.ID provides contract testing and method development and validation from its FDA inspected lab-oratories in USA and Germany. With over 5.000.000 identified parti-cles within the last 14 years rap.ID became a global institution for the root cause analysis of visible and sub visible particulate matter.
rommelag ag Fabrikweg 16 5033 - Buchs Switzerland P: +41 62834 5555 F: +41 62834 5500 mail@rommelag.ch www.rommelag.com
rommelag the inventor of Blow-Fill-Seal (BFS) Technology is the worldwide leading manufacturer and supplier of bottelpack aseptic machines for the packaging of sterile liquids. The bottelpack ma-chines are cGMP and FDA compliant. bottelpack aseptic machines have an integrated clean room class A (US-class 100). The machine capacity goes up to 30,000 containers / hour with volumes from 0.1 ml to over 1,000 ml. Plastic materials used are LDPE, MDPE, HDPE, PP, PET and others. We offer tests and contract fillings in our own laboratory and production utilities. rommelag is certified according to the new standard DIN EN ISO 9001: 2000.
Saint-Gobain 11400A 47th Street N 33762 - Clearwater United States P: +1 727 540 1060 227 linda.f.potter@saint-gobain.com www.biopharm.saint-gobain.com
As one of the world's largest manufacturers of high performance materials, Saint-Gobain Bioprocess Solutions is leading the way in critical fluid management. Our Collaborative Design Services devel-op customized single-use systems tailored to your bioprocess. We are the developer and manufacturer of industry standards: C-Flex, PharmaFluor, PharmaPure, Pure-FitÆ and Sani-Tech.
EXHIBITOR ABSTRACTS
PDA Europe supports the children's hospice „Sonnenhof”
The Sonnenhof Hospice, located near PDA’s office in Berlin, offers support and assistance to families with children suffering from incurable and/or debilitating diseases.
At Sonnenhof, children, together with their families, can spend the time they have left as they wish and find some relief from their suffering.
Instead of purchasing expensive gifts for the conference speakers, PDA has decided to donate this amount to the Sonnenhof Hospice. You can also contribute and help us in-crease the amount, it is easy: buy a package of chewing gums at the registration desk. THANK YOU!
To know more about the Sonnenhof Hospice, please visit www.bjoern-schulz-stiftung.de
SONNENHOF
SONNENHOF
SONNENHOF
Logo Sonnenhof - Farbwerte:Blau = C 100%/ M 30%/ Y 0%/ K 0%Gelb = C 0%/ M 25%/ Y 95%/ K 0%
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STERIS Deutschland GmbH Eupener Straße 70 50933 Cologne Germany T: +49 5136 97 06 12 2 F: +49 5136 97 06 12 1 andy_todd@steris.com www.STERISLifeSciences.com
STERIS Corporation is a leading provider of infection prevention and surgical products and services, focused primarily on critical health-care, pharmaceutical and research markets around the world. The Company supplies a broad array of equipment, consumable and service solutions that help assure productivity and quality. STERIS is listed on the New York Stock Exchange under the symbol STE. For more information, visit www.steris.com. STERIS has a comprehen-sive offering of detergents, disinfectants, skin care products and sterility assurance products that support your needs. We also have world class technical support to design the most effective cleaning program for your facility.
TERUMO Interleuvenlaan 40 3001 Leuven, Belgium Tel: +32 16 38 15 73 Fax: +32 16 381 604 info@terumo-gps.com www.terumo-gps.com
Founded in 1921 in Japan, Terumo is a global research & develop-ment company, offering a wide range of innovative products and services related to drug delivery devices, cardiology and cardiovas-cular systems, transfusion, patient monitoring and clinical systems. Terumo contributes to society by providing valued products and services in the healthcare market and by responding to the needs of healthcare providers and the people they serve. Unique technol-ogies and advanced devices are being offered to the pharmaceuti-cal industry in order to make medical treatment more comfortable, kinder and gentler.
Toxikon Europe NV Romeinsestraat 12 3001- Heverlee Belgium T: +32 16 400484 F: +32 16 401304 piet.christiaens@toxikon.be www.toxikon.be
Toxikon is a comprehensive testing organization, ISO-17025 accred-ited, providing a complete suite of services for the qualification and registration of medical devices, biomaterials and pharmaceuticals. Toxikon Europe is a subsidiary of Toxikon Corporation, a US based GLP-laboratory in Boston, covering the complete range of biocom-patibility and toxicology services. Toxikon Europe operates a state-of-the-art facility in Leuven, Belgium and specializes in the safety qualification of polymer materials (extractables studies, leachables studies). Other capabilities are lot release testing, microbiology and in-vitro toxicology procedures. All testing is performed according to the most recent guidelines, International and European Standards. Sponsor modified procedures, protocols, regulatory consultancy and analytical interpretation are available on request.
Veltek Associates Inc. 15 Lee Boulevard 19355 Malvern, PA United States Tel: +1 610 644 8335 Fax: +1 610 644 8334 vai@sterile.com www.sterile.com
Veltek Associates, Inc. is a single source supplier for all of your con-tamination control needs. VAI manufactures a broad line of sterile disinfectants, sporicides, cleaners and detergents in a variety of siz-es. In addition to multiple sizes, these products are available in sat-urated wipe packs. Veltek Associates, Inc.'s capabilities also include viable monitoring equipment. This product line consists of portable devices, compressed air / gas sampling and single unit multi loca-tion systems with an assortment of capabilities. Cleaning devices, laboratory services, cleanroom garments and consulting services are all part of the contamination control solutions VAI has to offer for every compliance challenge.
EXHIBITOR ABSTRACTS
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Watson-Marlow GmbH Mühlenweg 9 41569 - Rommerskirchen Germany P: +49 2183 42040F: +49 2183 82592info@wmftg.dewww.wmftg.de
Watson-Marlow Fluid Technology Group (WMFTG) is the world leader in niche peristaltic pumps and associated fluid path technologies for the food, pharmaceutical, chemical and environmental industries. Comprising nine established brands, each with their own area of ex-pertise, but together offering our customers unrivalled solutions for their pumping and fluid transfer applications. Customers demand many things from their process equipment and the prime concern is maintaining product integrity. Positive displacement pump compa-nies such as Watson-Marlow Fluid Technology Group (WMFTG) need to supply products which meet a range of requirements including: value for money; low cost of ownership; reliability; ease of main-tenance; and proven after sales service. We work closely with our customers to demonstrate how our positive displacement pumps ensure accurate metering, transfer and filling, can deliver significant process efficiencies over the lifetime of the equipment. WMFTG is a wholly owned subsidiary of Spirax-Sarco Engineering plc (LSE: SPX), a global organisation employing approximately 5,000 people world-wide. Watson-Marlow Fluid Technology Group comprises nine es-tablished brands, each with their own area of expertise, but together offering our customers unrivalled solutions for their pumping and fluid transfer applications
West Pharmaceutical Services Deutschland GmbH & Co.KG Stolberger Straße 21-41 52249 - Eschweiler Germany P: +49 2403 796 0 F: +49 2403 250 acsEurope@westpharma.com www.westpharma.com
West Pharmaceutical Services is a leading manufacturer of pack-aging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from con-cept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its cus-tomers from locations in North and South America, Europe, Asia and Australia
Wilco AG Rigackerstr. 11 5610 Wohlen Switzerland Tel: +41 56 618 43 43 Fax: +41 56 618 43 44 info@wilco.com www.wilco.com
WILCO AG provides in-line, off-line and laboratory machines with non-destructive testing methods for monitoring the oxygen content and container closure integrity simultaneously. Our patented leak detection methods based on the process analytical technologies (PAT) offers the opportunity for monitoring the finishing processes as well.We have newly implemented Visual Inspection technologies in our portfolio. With CCIT and Visual Inspection WILCO AG now cov-ers all inspection expectations for pharmaceutical products and our customers benefit from WILCO AG’s vast experience in quality inspection.
EXHIBITOR ABSTRACTS
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The Parenteral Drug Association presents...
PDA Education Program
30 June 2016Test Methods for Pre-filled Syringe Systems One-Day Training Course
30 June 2016Cleaning and Disinfection One-Day Training Course
30 June 2016How to Find the Right GMP for APIs One-Day Training Course
30 June - 01 July 2016Root Cause Investigation Two-Day Training Course
30 June - 01 July 2016Development and Manufacturing of Pre-filled Syringes Two-Day Workshop
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ONE-DAY TRAINING COURSE
Who Should Attend:
This course will be beneficial to individuals work-ing in Product Development, Quality Management, Regulatory Affairs and Manufacturing of syringe systems and related delivery devices
Learning Objectives:
Upon completion of this course, you will be able
• To understand the pros and cons of the different materials used for the Pre-filled Syringe
• To apply existing standards and monographs for specific syringe testing
• To explain the testing rationales used for test meth-ods at different stages
• To create a own testing plan according to your spe-cific application
Horst Koller, CEO, HK Packaging Consulting GmbH
Prior to becoming a consultant, Horst worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 20 years industry experience. His consulting company is focussing on Technical, Regulatory and QM-Support around Primary and Sec-ondary Packaging Systems including Medical Devices. He is an active member within the technical ISO Committees TC76 and TC84 as well as an active speaker on international conferences. He holds an Engineering degree in Biotechnology from the University of Applied Sciences in Mannheim / Germany.
OverviewPre-filled Syringes (PFS) are used for different applications and throughout many therapeutic areas. They are available in glass and polymer, with and without needles already pre-attached to the syringes. Pre-filled Syringes fulfill two tasks: storage container and delivery device in one and the same system.The more components are used in such systems the more complex it will get, additionally if such Pre-filled Syringes are used in Auto-injectors or other delivery devices.
This one-day course will cover a short introduction into common materials used for the development and manufacturing of syringe systems. The main focus is on the test methods which are relevant for the different stag-es of a Pre-filled Syringe.
Test Methods for Pre-filled Systems
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TRAINING COURSE AGENDA
Thursday, 30 June 2016 9:00 – 17:00
9:00 Welcome
9:15 Introduction to Syringe Systems & Components• Polymer Syringes• Glass Syringes• Rubber Components and Closures
10:15 Luer Cone and Luer Lock Compliance Testing for Glass and Polymer Syringes
11:00 Coffee Break
11:30 Requirements for the Empty Sterile Sub-assembled Syringe Ready for Filling• Cone Breakage• Flange Breakage• Leakage
12:30 Lunch Break
13:30 Requirements for the Empty Sterile Sub-assembled Syringe Ready for Filling (continued)• Break-loose and Gliding Forces• Needle Penetration• Particulate Matter• Endotoxins
14:30 Requirements for Finished Pre-filled Syringes • Pharmacopoeia• FDA
15:30 Coffee Break
16:00 Additional Testing for Use in Delivery Devices• Auto-Injectors
17:00 End of Training Course
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ONE-DAY TRAINING COURSE
Peter Koger, MSc., Technical Sales Manager International, Veltek Associates Inc.
Peter Koger has been active in life science for over 35 years. First 12 years were spend in different laboratories in microbiology and the remainder working for various international organizations, active in the life science/pharmaceutical industry. For about 20 years Peter has been a technical resource to the pharmaceutical industry in relation to viable monitoring, cleaning & disinfection, and other aspects related to Aseptic Manufacturing and Contamination Control. Since 2002, he is a frequent industry speaker and since 2004, Peter has been a faculty member of PDA and other training institutes. Peter worked with several companies to help them get to best practice level
in Cleaning & Disinfection. Since 2005, Peter is working with Veltek Associates Inc., a leading manufacturer of sterile disinfectants, detergents, viable moni-toring equipment and several other innovative products focused on Contamination Control in the Pharmaceutical and Biotech industry. In his role, Peter is Technical Sales Manager responsible for Europe and part of Asia.
Cleaning and DisinfectionA practical approach
Who Should Attend:
• Production management• Operators responsible for/involved in C&D• Quality/Microbiology management• Quality personnel involved in C&D
Learning Objectives:
At the end of the workshop attendees should be able to develop or evaluate an existing cleaning and disinfection program in line with regulatory expectations and facility’s requirements for contamination control of classified areas.
Overview
This interactive course deals with all aspects of cleaning and disinfecting a sterile manufacturing facility. The information shared will encompass regulatory aspects, Environmental Monitoring, contamination sources, selection of disinfectants and cleaning agents, the validation and how they should be used properly.
Thursday, 30 June 2016 9:00 – 18:00
9:00 Welcome & Introduction
Subject Introduction | General Framework | Directives | Guidelines | Expectations
10:30 Coffee Break
Environmental Monitoring and Risk Analysis | Root Cause of Contamination
12:30 Lunch Break
13:30 Selection Criteria | Validation | Means and Methods
15:30 Coffee Break
Practical Approach | Supplies and Tools | Case Studies
18:00 End of Training Course
www.rommelag.com
rommelag agP.O. Box · CH-5033 Buchs, SwitzerlandPhone: +41 62 834 55 55 Fax: +41 62 8345500E-mail: mail@rommelag.ch
rommelag Kunststoff-MaschinenVertriebsgesellschaft mbHP.O. Box 1611 · D-71306 Waiblingen, GermanyPhone: +49 7151 95811-0 Fax: +49 7151 15526E-mail: mail@rommelag.de
rommelag USA, Inc.27905 Meadow Drive, Suite 9Evergreen CO 80439, USAPhone: +1.303. 674.8333Fax: +1.303.670.2666E-Mail: mail@rommelag.com
rommelag Trading (Shanghai) Co., Ltd.Room 104~107,1st Floor, No.510 Zhongshan South 2nd Road,Xuhui District, Shanghai, 200032 P.R. ChinaPhone: +86 21 5153 4967, +86 21 5153 4968Fax No.: +86 21 5153 4969E-mail: romcn@rommelag.com
Advanced aseptic packaging in one operation cycleReliable – Simple – Cost-Effective
bottelpack® Technology:• Integrated clean room US-class 100• Recognized by GMP, FDA, JP …• Aseptic packaging of liquids, creams, ointments …• Endless container designs in PE, PP…
Your benefits:• Tamper-proof packaging• Easy to open• Simple to use• Shatter-proof, no splinter hazard
adver_EN_210x297mm3in1_okt_2015.indd 1 05.10.15 17:00
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An ICH Q7 expert working group member instructs
ONE-DAY TRAINING COURSE
Who Should Attend:
This course is designed specifically for those in-volved or interested in the manufacturing of APIs, the suppliers to API manufacturers or CMOs of APIs. The targeted audience comes from:
• Quality• Production• Logistics • Engineering
Learning Objectives:
Upon completion of this course, the attendee will be able to:
• Avoid an over-interpretation of the GMP requirements in API manufacturing
• Know the keywords of the ICH Q7 guideline and how to interpret the guideline correctly
• Know the different responsibilities of quality and production
• Realize the additional GMP requirements for Bio-technology APIs
• Understand the meaning of ‘critical’ and its impact on quality processes
• Determine at which point in API manufacturing GMP needs to be applied
• Know how materials are re-used in a correct manner• Know what needs to be documented and which
departments are involved
Lothar Hartmann, Ph.D., Managing Director, IQP Consulting
Lothar Hartmann served at Hoffmann-La Roche in numerous functions nationally and globally. Lothar acted as Global Head of “Pharma-ceutical Quality Systems & External Relations”, interacting with regulatory health authorities and associations, and as “Global Head of Knowledge Management”. He also acted as Head of Quality at Crucell Berne, a Johnson & Johnson Group of Companies, before he built up his own company ‘IPQ Consulting’. Lothar Hartmann served for more than 10 years on the board of APIC/CEFIC as Vice-Chairman. In this function, he was nominated for the ICH Q7a Expert Working Group, writing the worldwide-harmonized GMPs for APIs. In this effort,
he also was FDA awarded in May 2004. He also founded and chaired the internationally recognized EBEs BioManufacturing Working Group for a number of years. Lothar is co- and lead-author of various documents published by CEFIC/APIC and EBE (European Biopharmaceutical Enterprises). He also served on the PDA Board of Directors, chaired the European Interest Group on Quality Systems and was co-founder of PDA’s “Paradigm Change in Manufacture” (PCMO) project which had the objective to address practical solutions for the day-to-day business of the new paradigm of ICH Q8 – Q11. Lothar Hartmann graduated from the Technical University of Berlin.
OverviewWhen API manufactures received their own GMP guideline by ICH, an important step was reached since there are significant differences between GMP requirements for Drug (Medicinal) Products and those for APIs.
This course will provide practical guidance of key aspects laid down in the ICH Q7 guideline. It will clarify and lay out the appropriate GMP standard to be applied by API manufacturers. In particular, it will address GMP related topics of quality, production, logistics, engineering and biotechnology.
PDA Europe is proud to offer participants this unique opportunity to receive first-hand knowledge, interpretation and understanding of ICH Q7, and to ask questions to one of the ICH Q7 authors.
How to Find the Right GMP for APIs:
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TRAINING COURSE AGENDA
Thursday, 30 June 2016 9:00 – 17:30
9:00 Welcome & Expectation Round of Participants
9:30 Regulatory Environment for APIs
10:00 Quality
10:30 Coffee Break
11:00 Workshop (Draw Flowchart for Handling Deviations / Investigations)
11:30 Discussion of Outcome of Workshops
12:00 Keywords of ICH Q7
12:30 Lunch Break
13:30 Documentation
14:00 Workshop (Key Items of Major SOPs)
14:30 Discussion of Outcome of Workshops
15:00 Coffee Break
15:30 General GMPs for Production, Logistic & Engineering
16:00 Re-use of Materials
16:30 Special Requirements for Biotechnology
17:00 Final Discussion Round
17:30 End of Training Course
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TWO-DAY TRAINING COURSE
Who Should Attend:
Alumni of this program typically (though not exclu-sively) have a background in:
• Quality• Risk management• Regulatory affairs• Compliance• Manufacturing• Product development• CAPA• Supply chain & purchasing• Production• Engineering• Project management• R&D• Fraud management• and more
Learning Objectives:
Upon completion of the workshop, participants will able to immediately, effectively, and efficiently apply the methodology to:
• Identify the technical root cause(s), that is, the change(s) that occurred.
• Identify systemic root cause(s), that is, any underlin-ing breakdown in the organizations broader systems that allowed the change(s) to occur.
• Implement a comprehensive corrective and/or pre-ventive action plan to restore performance.
• Implement a control plan to minimize and/or pre-vent recurrence.
Rob Weaver, President of Weaver Consulting
Founded in 2003, Weaver Consulting is a two-person enterprise comprised of Tom Weaver and Rob Weaver. They are quality and oper-ations improvement consultants who focus their business exclusively on root cause analysis. With a combined 40+ years’ experience and a client base that expands worldwide, they have helped organizations across a multitude of highly regulated industries, including pharmaceutical, medical device, aerospace, defense, financial services, food & beverage, consumer products, automotive, telecom-munications, semiconductors, and many more, successfully implement their premier root cause analysis methodology, Root Cause
Investigation for CAPA. Both Tom and Rob held titles of Vice President in their respective careers before joining the firm, Tom with Baxter Healthcare and Rob with Wells Fargo & Company.
OverviewRoot Cause Investigation for CAPA is an informative, practical, and engaging two-day workshop teaching a system-atic, science based, and proven methodology ideal for investigating any performance change. Examples: change in the performance of a product (tangible or intangible), machine or equipment, work process or system (physical or virtual), escalated customer complaints, etc. Based upon 40+ years’ experience, the methodology integrates problem solving techniques from Total Quality Management (TQM), Six Sigma, Kaizen, DMAIC (define, measure, analyze, improve, control), as well as other problem solving and process improvement techniques.
On day one, the participants are introduced to the seven step root cause investigation methodology. An Investi-gation Roadmap is provided to guide the participants through the steps and suggest appropriate tools. After each step is presented leveraging an instructor case study, the participants immediately apply the learning on their own case study (which is based upon a real life investigation). On day two, several hours are devoted to strength-ening the participants’ skills leveraging the methodology through practice on another, more complex, real life case study. As the participants work on this case study they will compare their work with that of the investigation conducted by the real team.
Participants will be emailed a set of electronic templates. These templates, plus the investigation roadmap, guide the investigator through the methodology and provide the basis for documentation.
Root Cause Investigation for CAPA
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TRAINING COURSE AGENDA
Thursday, 30 June 2016 9:00 – 18:00
9:00 Welcome & Introduction• Define technical CAPA problem• Common investigation mistakes• Investigation Roadmap template• Introduce 1st participant real life case study
10:00 Step 1: Define the Performance Problem• Introduce instructor case study• Problem statement• Problem description
10:30 Coffee Break
11:00 Step 1 Continued• Problem description continued• Workshop• Flow chart process(es) being investigated & identify key
inputs• Workshop• Time of events• Team charter including performance & cost savings goals
12:00 Lunch Break
13:00 Step 2: Collect Data• Determine data needed• Data collection tools & techniques• Data measurement plan• Workshop
15:00 Coffee Break
15:30 Step 3: Identify Possible Causes• Time of changes• Differences between Is & Is Not facts• Workshop• Changes associated with identified differences• Review risk analysis• Brainstorming techniques• Workshop
16:30 Step 4: Test Possible Causes• Test possible causes against facts• Summarize testing leveraging contradiction matrix• Historical perspective of investigations• Workshop
17:30 Step 5: Identify Technical & Systemic Root Causes• Verify assumptions• Conduct studies/experiments• Identify technical root cause(s)
18:00 End of Day 1
Friday, 1 July 2016 9:00 – 16:30
9:00 Step 5 Continued• dentify systemic root causes
9:30 Step 6: Determine Corrective/Preventive Actions• Mistake proofing techniques• Variation reduction & optimization techniques• Corrective/preventive actions• Acceptance criteria
10:30 Coffee Break
11:00 Step 6 Continued• Risk mitigation• Control plan• Workshop
11:45 Step 7: Verify Corrective/Preventive Actions• Implement & measure corrective/preventive actions• Evaluate control plan• Determine additional preventive actions
12:00 Lunch Break
13:00 Second Participant Real Life Case Study• Introduction• Workshop to develop problem statement, problem
description, identify possible causes• Workshop to collect data• Workshop to test possible causes
15:00 Coffee Break
15:30 Second Participant Real Life Case Study Continued• Workshop to determine corrective/preventive actions
including risk mitigation, control plan, acceptance criteria
13:00 Closing Remarks• Compare/contrast this investigation methodology
with traditional approach• Shortcuts• Simple investigations• Difficult investigations• Investigation report• Return on investment• References
16:30 End of Course
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Including hands-on exercises with equipment for processing,inspection and control
TWO-DAY WORKSHOP
Who Should Attend:
This course offers valuable insights and updates for anyone involved in development, production, quality, and purchasing of pre-filled syringes and relevant equipment
Learning Objectives:
You will learn how:
• Processes involved in primary packaging manufac-turing, filling and processing influence quality
• Relevant equipment can be used to achieve reproducible quality
Development and Manufacturing of Pre-filled Syringes
Overview
This two-day workshop will provide an overview of relevant practical aspects and trends of developing and processing pre-sterilized primary packaging systems. It will also focus on hot topics such as aseptic environments, particulates, silicone and single-use filling. In addition to theoretical insights, participants will have the opportunity to use equipment and perform testing by themselves in hands-on sessions. Processing steps, inspection and quality aspects will be demonstrated using state-of-the-art technology.
Moderator: Christa Jansen-Otten, Director Marketing PFS Europa, West Pharmaceutical Systems Horst Koller, CEO, HK-Packaging Consulting
Speaker: Simone Biel, Field Marketing Specialist, Merck Millipore Maurizio Trombetta, Sales Manager, Metall + Plastic Oliver Valet, Managing Director, rap.ID Josef Veile, Director Engineering and Design, Groninger Patrizia Wenzel, Sales Manager, Biesterfeld Spezialchemie
Faculty
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WORKSHOP AGENDA
Thursday, 30 June 2016 9:00 – 17:45
9:00 Welcome and Introduction Christa Jansen-Otten, West
9:15 Market Overview and Trends in Primary Packaging:• Global & Regional Pharmaceutical Market / Injectable Market /
Challenges / Changes in Manufacturing / Devices
Christa Jansen-Otten, West
9:45 The Complete Process to Manufacture Pre-filled Syringes - From Washing to Packaging, Part I: • Material / Forming / Cleaning / Siliconization / Pre-Assembly / Sterilization
Josef Veile, Groninger
10:45 Coffee Break
11:15 The Complete Process to Manufacture Pre-filled Syringes - From Washing to Packaging, Part II: • Unpacking / Filling / Control & Close / Labelling / Packaging
Josef Veile, Groninger
11:45 Single-Use in Final Filling:• Process Design • Quality Considerations
Simone Biel, Merck Millipore
12:30 Lunch Break
13:30 Silicone: “The Chemistry Behind It” / Chemical and Physical Aspects Patrizia Wenzel, Biesterfeld Spezialchemie
14:00 Control of Silicone Layer and Particulate Matter:• Technology / Lubrication control / Investigation strategy / Distribution
and stability measurement / Relationship between silicone oil distribution and protein aggregation / Good Particles Investigation Practice / Visual classification / Documentation / Microscopy / Raman, LIBS, IR/ATR- Spectroscopy
Oliver Valet, rap.ID
14:45 Coffee Break
15:15 Hands-On Training using Industry Equipment:• Silicone distribution (rap.ID)• Siliconization (Groninger)• Silicone chemical/physical aspects (Biesterfeld)• Single Use (Merck Millipore)• Filling (Groninger)
Practical Training provided by various suppliers
17:15 Q & A, Open Discussion All
17:45 End of Day 1
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Friday, 1 July 2016 8:30 – 16:45
8:30 A Comparison of Pre-filled Syringes Filling Operations in RABS and Isolators
Maurizio Trombetta, Metall + Plastic
9:15 Material, Manufacturing, Process and Quality Effects on Glass:• Polymers / Coating / Multilayer
Horst Koller, HK Packaging
10:00 Coffee Break
10:30 Elastomeric Closures for Pre-filled Syringe and Cartridge Applications: • Manufacturing / Requirements / Coatings / Quality / Extractable /
Regulatory / Adopted Packaging
Christa Jansen-Otten, West
11:30 Comparing Different Solutions on Nested Containers• BD / Gerresheimer / NIPRO / OMPI / Schott / West
Horst Koller, HK Packaging
12:00 Q&A on Nested Packaging Horst Koller, HK Packaging
12:15 Development and Regulatory Aspects of Primary Packaging Material: Transfer from Vial into Syringe
Horst Koller, HK Packaging
13:15 Lunch Break
14:15 Hands-On:• Stoppering (Groninger)• Particle Identification (rap.ID)• Primary Packaging (West)• Packaging and Components (HK Packaging)
Practical Training provided by various suppliers
16:15 Q & A, Open Discussion All
16:45 End of Training Course
WORKSHOP AGENDA
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INFORMATION
V E N U EEstrel BerlinSonnenallee 22512057 BerlinGermanyTel.: + 49 (0) 30 683 10
CO NTAC T I N FO R M ATI O NConference InquiriesMelanie DeckerDirector Events & Exhibitionsdecker@pda.org
Conference Program InquiriesSylvia BeckerManager Programs & Eventsbecker@pda.org
Registration & Customer CareTel: + 49 30 4365508-10registration-europe@pda.org
Education Program InquiriesElke von LaufenbergManager Training & Educationlaufenberg@pda.org
Exhibition/Sponsorship Inquiries Creixell Espilla-GilartManager Exhibition & Sponsorship espilla@pda.org
O RG A N I Z E RPDA Europe gGmbHAm Borsigturm 6013507 Berlin, GermanyTel: + 49 30 4365508-0Fax: + 49 30 4365508-66info-europe@pda.org
E X PLO R E B E R LI N!PDA Europe is proud to offer you additional opportunities to explore Berlin whilst you are here! Don't miss experiencing some of the cultural variety Berlin has to offer. Partnering with PDA Europe, Art Berlin, a renowned tourism agency, has put together some activities for you to choose from.Make your stay in Berlin even more memorable and unique!
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Hints for Using Social Media We would like to encourage you in using Social Media Portals and to fuel the dialogue about
PDA Europe and the ‘‘1st PDA Europe Annual Meeting’’
PDA Europe is active on Twitter @PDA_Europe and LinkedIn PDA-Parenteral Drug Association Group.
For this meeting we are using the hashtag #pdaeuannual to upload all content related to
this conference on these platforms.
By joining LinkedIn and Twitter and using them to promote your participation in all of our
events, you can actively help increase the number of participants to any given event while
also drawing attention to your own company and to your personal profiles. Thus, together we
will maximize your exposure to the leaders and key decision makers of the pharmaceutical
and biopharmaceutical industry!
The PDA - Parenteral Drug Association Group and 1st PDA Europe Annual Meeting Group are open to everyone on LinkedIn. Please join these groups and become part of interesting discussions, raise
questions, show your involvement, interact with your peers and be present!
Example Content: “Looking for a cost-reduction on your primary packaging? We will be at the #pdaeuannual conference – visit us at table-top Nr. XXXX and get the chance to win an ipad/prize/whatever you want to give/ together with the best instrument for your new drug launch!’’ You can post a link to your own website, video on you tube, PDF brochure…
Before, during, and after the “1st PDA Europe Annual Meeting” the hashtag #pdaeuannual will be used to mark and identify event related tweets. This is perfect to let everybody know about your
involvement!
By using the hashtag #pdaeuannual, you further ensure that all tweets are collected under this topic, therefore creating a permanent history of all related tweets.
Example Tweet: “Our company will be exhibiting at the 1st PDA Europe Annual Meeting #pdaeuannual this year! Visit our booth in Hall C! @PDA_Europe”
Or “See our newest product at the 1st PDA Europe Annual Meeting #pdaeuannual @PDA_Europe” – you can add a link, a video or even a pdf presenting your product! There are many way of using this channel, feel free to post pictures, videos and the like.
You can also create a hashtag and / or account of your own company to link your posts.
SOCIAL MEDIA
Save the Date
13-14 June 2017
PDA Europe 2nd Annual Meeting
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