Oliver Chancel MicrobiologistSanofi-Aventis

John Duguid Principle Analytical ScientistGenzyme

Stephen RawlingMicrobiology Team LeaderGlaxoSmithKline

Hilary ChanQuality ScientistPfizer

Scott SmithMicrobiology Team LeaderSanofi-Aventis

Amy McDanielDirector, QC MicrobiologyPfizer

Anne WarfordAssociate DirectorMedImmune

Andrew BartkoSenior ScientistBattelle Research Institute

John KrincekDirector Quality AssuranceMerck

Emiliano Toso Principle ScientistMerck

KEY SPEAKERS INCLUDE:

WHY ATTEND THIS EVENT:• Discuss developments in tools, techniques and procedures

used in identification and control of contaminants • Sterile product manufacture and handling of traditional drug

and biologics• Hear about design, construction and validation of sterile

facilities and equipment • Engage with those currently working on producing the rapid

microbial methods

SMi present their 2nd annual conference on…

Pharmaceutical Microbiology

Wednesday 30th & Thursday 31st January, 2013 Marriot Regents Park, London, UK

www.pharma-microbiology.comRegister online and receive full information on all of SMi’s conferencesAlternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

REGISTER BY 28TH SEPTEMBER AND RECEIVE A £300 DISCOUNTREGISTER BY 31ST OCTOBER AND RECEIVE A £100 DISCOUNT

Sponsored by

Quality Scientist IV

Register online at www.pharma-microbiology.com • Alternatively f

8.30 Registration & Coffee

9.00 Chairman's Opening RemarksOliver Chancel, Head of Performance and Pharmaceutical SupportMerial, Sanofi-Aventis

Recent advances in microbiology

9.10 Monograph <1207> - Sterile product packaging is nice – Integrityevaluation is even better• Share a global and rationalised approach to control container

closure integrity at the best price• Initial qualification – microbial ingress testing to validate both the

stopper / bottle association and the crimping parameters• In process control – seal force testing to control the line in sealing

process through the filling of commercial batches• Stability studies – universal vacuum test to confirm container and

closure system integrity as part of the stability protocol Oliver Chancel, Microbiologist, Sanofi-Aventis

9.50 Selection, Validation, and Automation of a Rapid Mycoplasma Test”• Selection using a risk-based approach• Validation according to PhEur 2.6.7• Automation for routine testingJohn Duguid, Princible Analytical Scientist, Genzyme

10.30 Morning Coffee

10.50 Microbial risk assessment of objectionable organisms • Microbial risk assessment is a structured approach based on

science that can be applied to the risk management of objectionableorganisms

• The elements, hazard characterisation, exposure assessment andrisk characterisation

• Microbial risk assessment allows transparent and effective decisionmaking

Stephen Rawling, Microbiology Team Leader, GlaxoSmithKline

Contamination control

11.30 Non thermal plasmas for disinfection, sterilisation andcontamination control• The emerging field of plasma medicine and biocidal plasmas • Antimicrobial, antibiofilm and anti viral activity of non-thermal

plasmas• Mechanisms of action and potential applications in pharmaceutical

microbiology Brendan Gilmore, Research Scientist, Queens University Belfast

12.10 Networking Lunch

1.30 Rapid microbiology from a manufacturing perspective: available

technologies and potential applications

• Manufacturing perspective on rapid microbiology including case

studies

• Overview of technologies and potential applications

• Potential for moving testing to the manufacturing floor

Amy McDaniel, Director, QC Microbiology, Pfizer

2.10 Superheat phenomena in autoclaves

• The pehnomena of superhead and its relevance to sterilisation

technologies available to detect superhead conditions

• Variability found in commonly used daily steam quality tests

John Krincek, Director Quality Assurance, Merck

2. 50 Afternoon Tea

3.20 Creation and use of in-house naturally occurring endotoxin

preparation for spiking and hold time studies

• Creation of an in-house naturally occurring endotoxin (NOE)

preparation: organism choice, growth conditions etc

• Use of NOE in endotoxin spiking and hold time studies: design of

studies, recommended controls to use

• Difference between design and execution of hold time studies and

LAL validation studies

Kim Bowers, Senior Supervisor, Pfizer

4.00 Auditing suppliers to ensure product quality

• Recent history of bioreactor contaminations

• Regulatory expectations for biopharmaceuticals

• Raw material sampling, storage and transport best practices

• Environmental control expectations and use of QC in process and

environmental testing

• Case study of audit finding cases

Anne Warford, Associate Director, MedImmune

4.40 Chairman's Closing Remarks and Close of Day One

Pharmaceutical MicrobiologyDay One | Wednesday 30th January 2013 www.pharma-m

Sponsored by

As a leading provider of micro-contamination and environmental monitoring solutions, PMT (GB) Ltd.

are dedicated to the supply and service of instrumentation including particle counters, particle

identification, microbial air samplers and instantaneous microbial detection. In addition the PMT

group are the recognised core European distributors for Veltek’s range of sterile disinfectants and

cleanroom consumable products making us a complete micro-contamination control company.

www.pmtgb.com

fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

8.30 Registration & Coffee

9.00 Chairman's Opening RemarksOliver Chancel, Head of Performance and Pharmaceutical SupportMerial, Sanofi-Aventis

Investigative technologies

9.10 Effective microbial investigations

• Trigger points, laboratory failure and sample validity

• Collaboration and team work

• Manufacturing plant investigating

• Contributing factors, risk asses, conclusions and CAPA

Scott Smith, Microbiology Team Leader, Sanofi-Aventis

9.50 Rapid microbiology methods; A view from the trenches

• Technology selection

• ROI calculations

• Assay development

• Validation

• Regulatory submission

• Routine use and maintenance

Praful Bhusari, Associate Scientist, MedImmune

10.30 Morning Coffee

10.50 Molecular biology methods for viral safety: danger tool or perfect

solution

• The perception of using molecular biology and PCR based testing

• Faculty design, GMP compliance and highly trained personnel make a

difference

• Results

• Conclusions and validations for biopharmaceuticals quality control

Emiliano Toso, Principle Scientist, Merck

11.40 Process Analytical Technologies (PAT) Quality By Design

• What is PAT, definitions and PAT framework and processes

• Why PAT is necessary - process understaning and PAT tools PAT

applications to BET

• Current BET testing models and PAT aligned BET testing model

Efficiency case study

Gunther Meike, System Development Specialist, Charles River

Laboratories

12.20 Networking Lunch

1.40 Assessment of Solution and Raw Material Microbial Stability and

Testing Requirements in a Non-Sterile Manufacturing Environment

• Use of a multi-faceted evaluation tool, including water activity, for

establishment of non-sterile solution expiry based on microbial

stability/survivability

• Use of the same approach for determining appropriate microbial

testing of non-sterile raw materials

• Implementation of a procedure for assessing solutions and raw

materials allows a greater understanding of microbial stability,

reduction in testing requirements, and a streamlined documented

approach for audit preparedness

2.10 HACCP risk assessment used in microbial clean room qualification

• ISO 14698

• HACCP risk assessment in theory and praxis

• Clean room qualification of a new pharmaceutical plan

Daniel Kockelkorn, Head of PKau Laboratory EMT, Roche AG

2. 50 Afternoon Tea

Sterility Assurance

3.20 Integrated microbial and contaminant identification in manufacturing

process water

• Emerging rapid microbial methods

• Spectroscopic microbial identification

• Manufacturing process water quality

Andrew Bartko, Senior Scientist, Battelle Research Institute

4.00 How to produce a sterility assurance risk assessment for the whole

manufacturing process – raw material to finished product

• Application of a sterility assurance risk assessment

• CAPA qualification training process improvement

• Recent trends and obstacles

Mark Thompson, Consultant, EPIC Consultancy & Training

4.40 Chairman’s Closing Remarks and Close of Day Two

Day Two | Thursday 31st January 2013microbiology.com

Supported by SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and brandingpackages, uniquely tailored to complement your company’smarketing strategy. Prime networking opportunities exist toentertain, enhance and expand your client base within the contextof an independent discussion specific to your industry. Should youwish to join the increasing number of companies benefiting fromsponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk

Want to know how you can get involved?Interested in promoting your pharmaceutical

services to this market?Contact Kellee Halliburton, SMi Marketing on +44 (0) 207 827 6194,

or email khalliburton@smi-online.co.uk

Hilary Chan, Quality Scientist IV, Pfizer

PHARMACEUTICAL MICROBIOLOGYConference: Wednesday 30th & Thursday 31st January, 2013, Marriot Regents Park, London, UK

4 WAYS TO REGISTER

FAX your booking form to +44 (0) 870 9090 712PHONE on +44 (0) 870 9090 711

www.pharma-microbiology.comPOST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South,Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK

If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk

Payment: If payment is not made at the time of booking, then an invoice will be issued and must bepaid immediately and prior to the start of the event. If payment has not been received then credit carddetails will be requested and payment taken before entry to the event. Bookings within 7 days ofevent require payment on booking. Access to the Document Portal will not be given until paymenthas been received.

Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, anotherdelegate to take your place at any time prior to the start of the event. Two or more delegates maynot ‘share’ a place at an event. Please make separate bookings for each delegate.

Cancellation: If you wish to cancel your attendance at an event and you are unable to send asubstitute, then we will refund/credit 50% of the due fee less a £50 administration charge,providing that cancellation is made in writing and received at least 28 days prior to the start of theevent. Regretfully cancellation after this time cannot be accepted. We will however provide theconferences documentation via the Document Portal to any delegate who has paid but is unable toattend for any reason. Due to the interactive nature of the Briefings we are not normally able toprovide documentation in these circumstances. We cannot accept cancellations of orders placedfor Documentation or the Document Portal as these are reproduced specifically to order. If we haveto cancel the event for any reason, then we will make a full refund immediately, but disclaim anyfurther liability.

Alterations: It may become necessary for us to make alterations to the content, speakers, timing,venue or date of the event compared to the advertised programme.

Data Protection: The SMi Group gathers personal data in accordance with the UK Data ProtectionAct 1998 and we may use this to contact you by telephone, fax, post or email to tell you about otherproducts and services. Unless you tick here □ we may also share your data with third partiesoffering complementary products or services. If you have any queries or want to update any of thedata that we hold then please contact our Database Manager databasemanager@smi-online.co.ukor visit our website www.smi-online.co.uk/updates quoting the URN as detailed above youraddress on the attached letter.

Unique Reference Number

Our Reference LVP-071

Terms and Conditions of Booking

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Payment must be made to SMi Group Ltd, and received before the event, by one of thefollowing methods quoting reference P-071 and the delegate’s name. Bookings made within7 days of the event require payment on booking, methods of payment are below. Pleaseindicate method of payment:

□ UK BACS Sort Code 300009, Account 00936418□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU

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DOCUMENTATIONI cannot attend but would like to purchase access to the following DocumentPortal/paper copy documentation Price Total□ Access to the conference documentation

on the Document Portal £499.00 + VAT £598.80□ The Conference Presentations – paper copy £499.00 - £499.00

(or only £300 if ordered with the Document Portal)

PAYMENT

VENUE Marriott Hotel Regents Park, 128 King Henry's Road, London, NW3 3ST

□ Please contact me to book my hotelAlternatively call us on +44 (0) 870 9090 711, email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712

□ Book by 28th September to receive a £300 off the conference price□ Book by 31st October to receive a £100 off the conference price

EARLY BIRDDISCOUNT

CONFERENCE PRICESI would like to attend: (Please tick as appropriate) Fee Total

□ Conference only £1499.00 + VAT £1798.80

PROMOTIONAL LITERATURE DISTRIBUTION

□ Distribution of your company’s promotionalliterature to all conference attendees £999.00 + VAT £1198.80

GROUP DISCOUNTS AVAILABLE

The conference fee includes refreshments, lunch, conference papers and access to the Document Portal containing all of the presentations.

VATVAT at 20% is charged on the attendance fees for all delegates. VAT is also charged on DocumentPortal and Literature Distribution for all UK customers and for those EU customers not supplying a registration number for their own country here: ______________________________________