for life sciences · to the 2016 version of the iso 13485 standard and the impact on your quality...

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A division ofUBM Americas

Premier Media Partners: Supporting Media Partners: Signature Sponsor:

for Life Sciences

16th Annual

for Life SciencesFDA and EU Regulations • Connectivity Devices and Combination Products • Surveillance • Thresholds

J U N E 1 9 - 2 1 , 2 0 1 8 | H I LT O N O L D T O W N | A L E X A N D R I A , VA

Benchmarking Tools, Best Practices and Practical Takeaways• Post-market safety reporting for

combination products

• Managing risks while dealing with product complaints

• Setting up valuable customer complaint surveillance reporting to management

• Preparing for ISO 13485:2016

• Creating complaint trending systems for drug and device products

NEW Sessions This Year!• Strategies for Utilizing Statistical

Information to Set Complaint Thresholds• Best Practices for Complying with the

EU Medical Device Regulation• Create a Superior Customer Experience

While Managing Product Complaints• Explore the Impact of Social Media

Industry Perspectives from:•Shire • Abbott • Novocure•ResMed • Eli Lilly & Company •Novo Nordisk A/S • Vyaire Medical •Roche Molecular Diagnostics

PLUS! AN IN-DEPTH 3-HOUR WORKSHOP:

Evaluate How Connected Devices Impact Your Complaint Handling Process

A Great Place to Meet Your Market!Take advantage of the best opportunity to meet potential clients face-to-face. Build relationships while demonstrating thought

leadership and sharing expertise. For more information on how to position your company as a sponsor or exhibitor, contact, Hunter Gates at 339-298-2108 or email [email protected].

Signature Sponsor

REGISTER AT WWW.CBINET.COM/COMPLAINTS • 800-817-8601 REGISTER AT WWW.CBINET.COM/COMPLAINTS • 800-817-8601

Back for its 16th year, CBI’s Product Complaints Congress is the industry’s gold standard event for

bio/pharmaceutical and medical device professionals responsible for complaint management. As the

digital landscape continues to evolve, it is more important than ever for industry thought leaders to

benchmark with their peers and discuss innovative best practices for measuring the effectiveness

of their complaint handling system. Compare thresholds, analyze the impact of social media, take a

deep dive into post-market safety reporting for combination products and more.

DYNAMIC DISCUSSIONS LED BY INDUSTRY LEADERS:Khaudeja Bano, Senior Medical Director, Medical Device Safety Head, Abbott

Vaishali Shukla, Head of Clinical QA and Product Quality Management, uniQure

Sharon Perez, Director, Global Medical Safety, Novocure

Susan Busse, Advisor of Global Product Complaints, Eli Lilly Company

Rikke Lewinsky, Specialist, Post Market Surveillance, Novo Nordisk A/S

Alex Patterson, Director, Post Market Quality, ResMed

Ron Makar CBA, CHA, CQA, CQE, CMQ-OE (ASQ), Owner & Principal Consultant, Innovative Quality Consulting, LLC

T. Che Jarrell, BSPH, MPIA, RAC, Proprietor and Principal Consultant, Milestone Regulatory Experts, LLC

Sonny Nguyen, Director, QA/RA, PeriGen, Inc

Kari Miller, VP, Regulatory and Product Management, Pilgrim Quality Solutions

Lawrence S. Perruzza, M.Sc., RAC, Director, Case Investigation & Resolution, Roche Molecular Diagnostics

Chris Silvers, Vice President of Quality Assurance & Compliance, Vyaire Medical

WHO SHOULD ATTEND:

Directors, managers and other senior-level professionals from pharmaceutical, biotech and medical device companies with responsibilities in the following fields:

• Product Complaints• Product Quality• QA/QC• Product Safety• Quality Systems and Engineering• Patient Safety• Medical Affairs• Consumer Affairs• Regulatory Affairs• Call Centers/Customer Service• Compliance• Pharmacovigilance

This conference will also benefit complaint tracking software system providers, inbound call centers, consulting firms and law firms.

DAY ONE Tuesday, June 19, 2018


8:00 Continental Breakfast

8:30 Chairperson’s Review of Day OneAlex Patterson, Director, Post Market Quality, ResMed

8:45 Assess FDA Inspection Process for Product Complaints • What is an inspection and what are the reasons for

an inspection?• Understand how FDA will approach and inspection• Hear how to best prepare for an inspection• Learn what to do during an inspection Lawrence S. Perruzza, M.Sc., RAC, Director, Case Investigation & Resolution, Roche Molecular Diagnostics

9:30 Evaluate Best Practices for Managing Risks While Dealing with Product Complaints

l. Introduction to Risk Management• Review the FDA’s risk-based approach initiative

• What is a risk?

• Why should we care about risk?

II. Framework for Managing Risk • Asses the risk management principles • Learn about risk management in handling

pharmaceutical product complaints • Navigate risk assessment and evaluation • Hear how to implement the input from complaints for

product improvement opportunity

III. Risk Control • Learn how to mitigate and reduce risk

• Walk through experiences with vigilance and complaint inspections

• Understand how to control the risk associated with global integration of product complaints

IV. Interactive Exercise• Tools & techniques for qualitative risk analysis

• Tools & techniques for quantitative risk analysisVaishali Shukla, Head of Clinical QA and Product Quality Management, uniQure

11:00 Networking and Refreshment Break

DAY TWO Wednesday, June 20, 2018

12:00 Main Conference Registration

1:15 Chairman’s Welcome and Opening RemarksAlex Patterson, Director, Post Market Quality, ResMed

1:30 REMOTE PRESENTATION Uncover the Recipe for Successful Post-Market Safety Reporting for Combination Products• Learn how to manage co-packaged products

• Review updated finalized FDA guidelines and timelines

• Evaluate the expectations and how organizations can be set up for success

Khaudeja Bano, Senior Medical Director, Medical Device Safety Head, Abbott

2:30 Sharing Vyaire Medical’s Journey to Improve Efficiency from a Data Perspective-Post Market SurveillanceFor today’s medical device companies, the role of field services remains the heart of Customer Service and Loyalty. In this highly regulated Life Science Field Services Industry, efficiency with compliance is critical. Learn how to execute fast, drive rapid business adoption and use validated SaaS Cloud Platform to transform the Customer Experience. The discussion will include how Medical Device Leaders are moving to the Cloud to take advantage of all the benefits of a cloud field service solution and remain compliant while doing it. And because it’s a regulated industry, field service is having to quickly adhere to updates and improvements regarding industry regulations• Focus: Process / Change Management First /

Technology second• Effective Business & Technology benefits of the

SaaS Platform

• Optimize Program Execution — Speed with Quality Chris Silvers, Vice President of Quality Assurance & Compliance, Vyaire Medical

3:15 Networking and Refreshment Break

3:45 Hot Topic Review PanelReview the most popular topics that were discussed throughout Day One of the conference. During this interactive panel discussion, attendees have the chance to ask lingering questions and share their experiences.Panelists:Alex Patterson, Director, Post Market Quality, ResMedRon Makar CBA, CHA, CQA, CQE, CMQ-OE (ASQ), Owner & Principal Consultant, Innovative Quality Consulting, LLCSharon Perez, Director, Global Medical Safety, Novocure

4:30 Strategies for Utilizing Statistical Information to Set Complaint Thresholds• Implementing complaint thresholds —

Where do I start?

• Using statistical methodology to establish complaint thresholds

• Complaint codes vs failure codes — Which is best?

• Share best practices for determining if there is a product issue

Sonny Nguyen, Director, QA/RA, PeriGen, Inc

5:15 Close of Day One

Networking, Wine and Cheese Receptionimmediately following the final session on day one

This session examines critical changes to the 2016 version of the ISO 13485 standard and the impact on your quality management system. Emphasis will be placed on post-market surveillance activities, such as obtaining customer feedback, effectively handling complaints, reporting to regulatory authorities and monitoring and measuring of product. Interactive exercises include taking a look at how process controls are expected to be proportional to the level of risk throughout the entire QMS.

l. Examining the Critical Changes of This Standard• What procedures are required?

• Integrating the changes into your QMS together with FDA Quality System Regulations — How are they different?

• How risk-based thinking and decision making applies to QMS processes

• Integrating your quality management processes into the standard, including determining the sequence and interaction of these processes

• Determining if your infrastructure is capable of effectively managing your QMS processes

ll. Post-Market Surveillance• How do you acquire customer

feedback?

• How to know if your complaint handling processes is effective?

• When are you required to report to regulatory authorities?

• Learn how to develop effective product monitoring and measurement metrics

III. Interactive ExerciseDuring this interactive exercise, attendees examine selected quality processes applicable to their business, identify sources of variability and potential risk impacting expected outcomes of these processes and identify control measures required to minimize the likelihood of the occurrence of process failures.

BONUS MATERIALS:• A road map to establishing

an integrated quality management system for medical device manufacturers, consisting mainly of an audit checklist showing how the FDA Quality System Regulation, ISO 9001:2015 and ISO 13485:2016 complement each other

Ron Makar CBA, CHA, CQA, CQE, CMQ-OE (ASQ), Owner & Principal Consultant, Innovative Quality Consulting, LLC

Session 4: ISO 13485:2016 — Preparing for the International Medical Device QMS Standard

REGISTER AT WWW.CBINET.COM/COMPLAINTS • 800-817-8601 REGISTER AT WWW.CBINET.COM/COMPLAINTS • 800-817-8601

1 1 : 3 0 C H O O S E B E T W E E N T W O 9 0 – M I N U T E S E S S I O N S ( 3 - 4 )

1 : 0 0 N E T W O R K I N G L U N C H E O N

I. Managing the Product Complaint Intake Processes• Navigate the path to well-

trained call center agents

• Hear how to balance customer expectations for the interaction and data gathering to meet global regulatory requirements

• Setting the customer expectations for what happens next in the product complaint process

II. Responding to Customers Regarding their Product Complaint• Timely response using the

preferred customer channel and message understood by the customer

• Global support for locally implemented solutions tailored for cultural expectations

III. Product Complaint Prevention• Managing a global program

to take actions in response to product complaint trends related to the customer experience

• Partnering cross-functionally to address product complaint causes, including education programs

Susan Busse, Advisor of Global Product Complaints, Eli Lilly & Company

Session 3: Create a Superior Customer Experience While Managing Product Complaints

I. EU Medical Device Regulation• Identify the major changes in

the EU MDR, including UDI, post-market surveillance, clinical evaluation and eudamed

• Discuss how other EU standards and guidelines, including MEDDEV 2.7.1 and EN ISO 13485:2016, intersect with the EU MDR

II. Prepare for EU MDR Implementation• Perform a gap assessment

• Create an action plan for the EU MDR transition

• Discover how to stay informed of changes during the transition period

III. Interactive ExerciseIn this interactive portion of the session, attendees share challenges already faced by EU MDR implementation and how they have been overcome.Sharon Perez, Director, Global Medical Safety, Novocure

Session 2: Best Practices for Complying with the EU Medical Device Regulation

• What are the impacts of data collection on safety?

• Understand how to compile / submit a Single Patient IND

• Assess the IND review process and procedures

• Review IND sponsor-investigator responsibilities

• Discuss the new Right to Try Law


Session 9: Single patient INDs and the New Right to Try Law


2 : 0 0 C H O O S E B E T W E E N T W O 9 0 – M I N U T E S E S S I O N S ( 2 O R 9 )

3 : 3 0 N E T W O R K I N G A N D R E F R E S H M E N T B R E A K

l. Survey FDA’s FAERS System — Leverage evaluation principles and recognize limitations • Understand what FAERS is

designed to do

• Unpack how FDA uses information in FAERS and how it presents data via the FAERS Public Dashboard

• Review the stakeholders and their motivations

• Understand the means of reporting an adverse event or medication error to FDA

• Appreciate FAERS’ limitations

ll. Deconstruct the Product Complaint/Adverse Event Report • Identify the what, when,

where, why, how, and who of an incident report

• Focus on the three most mportant questions regarding incident reporting

• Learn how to implement best practices for successful incident report collection and evaluation

• Hear what to report and what not to report to the FDA Medwatch System

lll. Develop an Algorithm/Feedback Loop-Based System that Accurately Measures Product/Performance Outcomes• Learn how to develop and

implement a system designed to differentiate between a trend and random error

• Think like the FDA and leverage its tools and methodology (e.g., MedWatch to Manufacturer Program)

• Recognize how to implement a frequent and thorough data analysis protocol that engenders continuous, precise and accurate assessment of a product’s safety profile

lV. Scenarios/Interactive Activity• Two case studies/hypothetical

situations emphasize the content discussed earlier in the presentation

BONUS MATERIAL• Related Tools and Templates


Session 5: Assess How to Create Complaint Trending Systems for Drug and Device Products

4 : 0 0 C H O O S E B E T W E E N T W O 9 0 – M I N U T E S E S S I O N S ( 5 - 6 )


• Best practices in obtaining event and product information: what, when, and how

• Discover the importance of appropriate complaint documentation and how to avoid common pitfalls

• Review common mistakes in MDR reports and how to combat them

• Learn about complaint file review methods to prevent missed MDR reporting

• Evaluate complaint and MDR tracking methods to ensure timely MDR submissions

Geoffrey Gannon, Product Surveillance Manager, Zimmer Biomet

Session 6: Best Practices in Device Complaint Investigation, Documentation, and MDR Reporting

5 : 3 0 C L O S E O F D A Y T W O

DAY THREE Thursday, June 21, 2018

8 : 4 5 - 1 2 : 1 5 I N - C O N F E R E N C E 3 - H O U R W O R K S H O P

PRESENTATION 1: Creating a Robust Complaint System on High-Volume, End-User Products• Learn the requirement towards connectivity

devices/apps from a regulatory point of view

• Understand how to setup complaint handling between one or more companies

• Evaluate how to split responsibility, investigation time and contracts in relation to connected-devices with interfaces across companies

• Explore how to share data between partners

PRESENTATION 2: Look at the Similarities and Differences Between Complaint Handling of Traditional vs Connected Devices• Discuss importance of definitions — What are

you made aware of as a manufacturer when your devices are connected and sending data all the time?

• How do we adjust our metrics and trending for connectivity?

• Combat challenge of patient privacy

Round Table Discussion 1: Mobile phones, wearables and connected devices — Evaluate digital health impact the complaint handling process

Round Table Discussion 2:Software as medical devices — How do we evaluate alleged deficiencies in software products like apps?

Interactive ExerciseDuring this session participants discuss opportunities and pitfalls with new data-driven technologies in relation to complaint handling.

• What are the opportunities (quality, business, operational) from connectivity?

* unearth the benefits of complaint data and digital health data to product development and research

* learn how to improve visibility of quality issues

• How do QA/RA teams need to evolve to be effective in digital health?

* understand the software development cycle

* take a deep dive into the production environment for connectivity (telcos, server infrastructure, etc.)

Workshop Leaders:Rikke Lewinsky, Specialist, Post market surveillance, Novo Nordisk A/S Alex Patterson, Director, Post Market Quality, ResMed*There will be a 30-minute networking and refreshment break at 10:30

Evaluate How Connected Devices Impact Your Complaints Handling Process

8:00 Continental Breakfast

8:30 Chairperson’s Review of Day TwoAlex Patterson, Director, Post Market Quality, ResMed


1 2 : 1 5 N E T W O R K I N G L U N C H E O N

2 : 3 0 C L O S E O F C O N F E R E N C E

I. Guidelines and Enforcement Activities Involving Social Media• Review US and EU guidelines

affecting social media activity

• Discuss FDA enforcement activities involving social media

• Understand how social media may affect complaint handling

II. Social Media Activity in the Pharmaceutical and Medical Device Industries• Identify common social

media activities used by the pharmaceutical and medical device industries

• Analyze the content and quality of data arising from social media activity

• Review industry best practices for social media use

• Create a social media policy that ensures compliance

III. Interactive ExerciseIn this interactive portion of the session, attendees are challenged to search the internet for examples of pharmaceutical and medical device social media activity.

Sharon Perez, Director, Global Medical Safety, Novocure

Session 7: Explore the Impact of Social Media on the Pharmaceutical and Medical Device Industries

1 : 0 0 C H O O S E B E T W E E N T W O 9 0 – M I N U T E S E S S I O N S ( 7 - 8 )

Meeting the reporting legal requirements of regulations, such as the EU Medical Device Reporting (MDR), and the recently-mandated EU General Data Protection Regulation (GDPR), can be a daunting task. With seemingly clashing requirements, the balancing act that needs to occur within an organization to achieve compliance to both is a delicate one. Has your organization considered the impact of consistently meeting these two regulations simultaneously? This session familiarizes you with both regulations, with a special focus on the critical consideration for implementing them within your organization.

• Overview of the regulations

• Identification of organizational impact

• Special areas of focus

• Implementation and system(s) considerations

• Next steps in the achievement of compliance

Kari Miller, Vice President, Regulatory and Product Management, Pilgrim Quality Solutions

Session 8: The Balancing Act Between Regulatory Requirements — Public Interest vs Individual Privacy Rights in the EU MDR vs EU GDPR

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A division ofUBM Americas

Product Complaints Congress PC18120

VENUE: Hilton Alexandria Old Town1767 King StreetAlexandria, VA 22314Phone Reservations: (800) 445-8667Hotel Direct Line: (703) 837-0440

ACCOMMODATIONS: To receive CBI’s special discounted hotel rate online or by phone, please go to:

• Online: www.cbinet.com/complaints• Phone reservations: (800) 445-8667 and mention CBI’s Product ComplaintsBook Now! The Hilton Old Town is accepting reservations on a space and rate availability basis. Rooms are limited, so please book early. All travel arrangements subject to availability.

PLEASE NOTE: All hotel reservations for this conference should be booked directly with the hotel. CBI does not use Housing Bureaus and none are authorized to call on our behalf.

CHOOSE YOUR SESSIONS BELOW:DAY TWO — WEDNESDAY, JUNE 20, 2018

11:30-1:00 3 4

1:15-2:45 2 9

3:15-4:45 5 6

DAY THREE — THURSDAY, 21 JUNE 2018

1:30-3:00 7 8

REGISTRATION FEE: ADVANTAGE PRICING Standard Onsite Conference $2399 $2699 $2799

Register by May 18, 2018 and SAVE $300. Fee includes continental breakfast, lunch, wine and cheese reception, refreshments and conference documentation. Credit Card (Visa, MC, AMEX, Discover) or checks accepted. Please make checks (in U.S. funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted.) PLEASE NOTE: All advertised discounts are taken from the full, Standard Rate.

GROUP RATE: Looking to bring your team? Contact Information Services to learn about potential group savings. Call 800-817-8601 or email [email protected].

* Advantage pricing rates do apply when applicable. Offer may not be combined with any other special pricing promotions. Offer may be used at CBI co-located events.

SATISFACTION GUARANTEED: CBI stands behind the quality of its conferences. If you are not satisfied with the quality of the conference, a credit will be awarded towards a comparable CBI conference of your choice. Please contact 800-817-8601 for further information. Advanced preparation for CBI conferences is not required.

SUBSTITUTION AND CANCELLATION: Your registration may be transferred to a member of your organization up to 24 hours in advance of the conference. All cancellations received in writing on or before 14 days prior to the start date of the event will be refunded, less a $399 administrative charge. No refunds will be made after this date; however, the registration fee less the $399 administrative charge can be credited to another CBI conference if you register within 30 days from the date of this conference to an alternative CBI conference scheduled within the next six months. In case of conference cancellation, CBI’s liability is limited to refund of the conference registration fee only. Cancellation of a conference due to events beyond our control* are subject to a $399 administrative charge should you or a colleague be unable to attend the rescheduled date. CBI reserves the right to alter this program without prior notice. Please Note: Speakers and agenda are subject to change. In the event of a speaker cancellation, every effort to find a suitable replacement will be made. The opinions of the conference faculty do not necessarily reflect those of the companies they represent or CBI.

*Events beyond our control include: severe weather conditions, natural and man-made disasters and any other similar events.


for Life Sciences

16th Annual

for Life SciencesFDA and EU Regulations • Connectivity Devices and Combination Products • Surveillance • Thresholds

J U N E 1 9 - 2 1 , 2 0 1 8 | H I LT O N O L D T O W N | A L E X A N D R I A , VA

ANY QUESTIONS OR TO REGISTER CONTACT:

John Kuchinski phone 339-298-2112 email [email protected]

for life sciences · to the 2016 version of the iso 13485 standard and the impact on your quality...

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