the parenteral drug association presents: pharmaceutical

PharmaceuticalMicrobiology

PDA Europe Conference, Exhibition, Education

Simulcast Conference

15-16 October 2018 | Berlin | Germany 15-17 October 2018 | Bethesda | USA

The Parenteral Drug Association presents:

The Future of Pharmaceutical Microbiology: Small World, Big Opportunities

C O N F E R E N C E G U I D E

AT T E N D E E N A M E

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WELCOME FROM THE CHAIRS

Dear Colleagues,

On behalf of the Program Planning Committee, we warmly welcome you to the PDA Europe 9th Conference on Pharmaceutical Microbiology in Berlin, Germany!

This year’s conference promises special highlights as we will simulcast selected sessions live between PDA conferences in Berlin, Germany and Bethesda, USA.

Current industry practices associated with microbial contamination control, aseptic manufacturing strate-gies, endotoxin challenges, mycoplasma detection and the implementation of alternative and rapid microbi-ological methods are just a few of the issues we will address.

Aspects of manufacturing of microbiological products and their associated strategies for control, including gene and cellular products, vaccines and other therapeutic and prophylactic medicines will be further highlights of this joint conference program.

We look forward to engaging with you in this truly global PDA meeting!

Welcome to Berlin!

SCIENTIFIC PL ANNING COMMIT TEE

Michael J.Miller, Microbiology Consultants, Chair

Marsha Steed, ValSource, Co-Chair

Walid El Azab, STERIS Corporation

Peter Kitschmann, Bausch & Stroebel

Heike Merget-Millitzer, Janssen J&J

Jeanne Moldenhauer, Excellent Pharma

Johannes Reich, Microcoat

Olivier C. Rocher, GSK Vaccines

Anil Sawant, MSD

Kerstin Wilken, PDA Europe

Sylvia Becker, PDA Europe, Manager Programs & Events

Michael J. Miller, PhD Microbiology Consultants, Chair


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S C H E D U L E A T A G L A N C E

15 October 9:00 – 18:00 Pharmaceutical Microbiology Conference, Exhibition

15 October 18:30 – 21:30 Networking Event

16 October 9:00 – 16:30 Pharmaceutical Microbiology Conference, Exhibition

17 October18 October

9:00 – 18:009:00 – 16:30 Rapid Microbiological Methods Training Course


9:00 – 17:159:00 – 16:30

Mastering Challenges of Data Integrity and Computer System Validation Training Course


9:00 – 18:009:00 – 16:30

Environmental Monitoring and Contamination Control Training Course


9:00 – 17:459:00 – 16:30

Best Practices and Points to Consider in Aseptic Processing Training Course

Join @PDA_Europe on Twitter and post pictures and highlights of this meeting! #PDAmicro Follow us on LinkedIn linkedin.com/company/pda/

WELCOME TO

BERLIN

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CONFERENCE AGENDA

Monday, 15 October 2018

9:00 Welcome and Introduction Kerstin Wilken, PDA EuropeMichael J. Miller, Microbiology Consultants, Chair


Keynote Pharmaceutical Microbiology: Current and Future Challenges Tim Sandle, Bio Products Laboratory

We are very fortunate to have Dr. Tim Sandle, one of Europe’s leading experts in pharmaceutical microbiology, deliver this year’s keynote address. Dr. Sandle will discuss the changing and challenging environment for microbiology, including the need for novel alternative and rapid methods, single-use technologies and why it is important to separate people from our processes. He will address best practices and new opportunities for environmental monitoring, current expectations for con-tamination control programs and where the industry is regarding objectionable organisms.

OPENING PLENARY

Session 1 Regulatory Update Moderator: Heike Merget-Millitzer, Janssen J&J

This session will provide Regulatory Perspectives on general Pharmaceutical Microbiology with special focus on microbial testing of Advanced Therapeutic Medicinal Products (ATMPs).

9:45 Microbiological Quality Control and Approval of Cell and Tissue Products

Isabelle Bekeredijan-Ding, Paul-Ehlich-Institut

10:15 Microbiological Quality Control – the Role of an Official Medicines Control Laboratory (OMCL) in Post-Market Surveillance Plans

Luis Soares, INFARMED

10:45 Q&A, Discussion

11:00 Coffee Break, Poster Session & Exhibition

Session 2 Low Endotoxin Recovery and Pyrogen Testing Moderator: Walid El Azab, Steris

The bacterial endotoxins test (BET) is a critical requirement for injectable products and medical devices required to be pyro-gen-free. Recently, the Japanese Pharmaceutical and Medical Device Agency published a collaborative study demonstrating equivalence between recombinant Factor C Test (rFC) and LAL. As technologies have advanced, new test methods like the rFC and Monocyte Activation Test (MAT) have been developed and made commercially available. Therefore, the goal of this session is to discuss the challenges associated with the detection and recovery of endotoxin within our industry and also share critical parts of the brand new PDA Technical Report on LER.

11:30 The Changing Environment in Pyrogen and Endotoxin Testing & the PDA Technical Report: Low Endotoxin Recovery

Johannes Reich, Microcoat

12:00 LER Case Studies from a CMO Perspective Priska Zenhäusern, LONZA

12:30 A Time-Saving Recombinant Horseshoe Crab Factor C Endotoxin Test Including a Novel Microplate

Gregory Devulder, bioMerieux


13:15 Lunch Break, Poster Session & Exhibition

The PDA is proud to invite you to a very special Networking Event

Monday, 15 October 2018 18:30h – Meeting Point: Hotel Lobby Joint Walking Tour to the restaurant19:00h – Dinner, Restaurant Maximilians, Friedrichstrasse 185-190, 10117 Berlin21:30h – Walking Tour back to Conference Hotel

Join us for a fabulous evening in a traditional Bavarian Restaurant.

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CONFERENCE AGENDA

SIMULCAST SESSION WITH PDA USA, BETHESDA, MARYLAND

Session 3 The New Frontier of Personalized Medicine: Regulatory Expectations and Microbiological Challenges

Moderator EU:Moderator US:

Kerstin Wilken, PDA EuropeKim Sobien, PETNET Solutions

Imagine using your own body’s cells to cure cancer – the idea has recently been made tangible and has been shown to be successful with new discoveries in the field of immuno-oncology. CAR T (Chimeric Antigen Receptor T-Cell) therapy is a novel, cellular therapy that supercharges a patient’s own immune system T-cells and programs them to attack designated cancer cells in the body. Significant challenges with facility design, room classification, manufacturing, testing, and regulatory ap-proval have been brought forth as several of these personalized “living drug” therapies have achieved commercialization. This opening plenary session will explore CAR T product manufacturing challenges from an industry perspective and discuss regulatory challenges for commercialization and the use of non-compendial microbiology methods.

14:00 Opening Remarks US Conference Kim Sobien, PETNET Solutions Speaking from Bethesda

14:15 Regulatory Challenges to CAR T Commercialization Yoko Momonoi, Regulatory CMC, Celgene Speaking from Bethesda

14:45 CAR T Cell Therapies: Regulatory Considerations for Safety Testing

Kimberly L. Schultz, CBER, US FDA, Speaking from Bethesda



https://pda.org/EU/PharmaMicro

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CONFERENCE AGENDA


Session 4 Current Regulations in EU and US Moderator EU:Moderator US:

Michael J. Miller, Microbiology ConsultantsJulie Barlasov-Brown, MSD

Current regulatory and inspection trends will be the focus of this very popular session and this year we are fortunate to simulcast presentations from both European and the FDA representatives. Renowned MHRA microbiology expert and GMP inspector, Andrew Hopkins, will provide an update on the long-awaited revision to Annex 1, Manufacture of Sterile Medicinal Products. Justin Boyd, an investigator in the Office of Regulatory Affairs with FDA’s Team Biologics. will present an overview of recent investigational findings and discuss some of the most significant non-compliance issues facing the industry.

16:15 Microbiological Implications of the EU Annex 1 Revision Andrew Hopkins, MHRA Speaking from Berlin

16:45 Common Inspection Trends Justin A. Boyd, US FDA Speaking from Bethesda


18:00 End of Day 1 and Networking Event

Tuesday, 16 October 2018

Session 5 Current Advances in Alternative and Rapid Microbiological Methods

Moderator: Heike Merget-Millitzer, Janssen J&J

In this session, we will present alternative solutions to contamination detection & control. Starting with an update on using PCR for Mycoplasma Safety Testing, we will also take a closer look at innovative developments in the field of microbial iden-tification with a focus on the rapid identification platform of MALDI-TOF mass spectrometry. We will close this session with an introduction to a novel, non-invasive ap proach to cell analysis and identification. Dr. Schuetze developed a method using Raman Spectroscopy which holds great potential for accelerated quality control of cell-based products.

9:00 Mycoplasmas in Biopharmaceutical Production Processes:Risk Assessments as Basis for Validation and Implementation of PCR Methods for Mycoplasma Safety Testing

Renate Rosengarten, University of Veterinary Medicine Vienna & Mycosafe Consulting

9:30 Evaluation of Scientific Advances to Improve the Performance of Identification Options for the Laboratory

Prasanna Khot, Charles River Labs

10:00 Label-Free and Non-Invasive Single Cell Analysis Using Raman Spectroscopy

Karin Schütze, CellTool



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CONFERENCE AGENDA

Session 6 Contamination Control Moderator: Marsha Steed, ValSource

Contamination control is an essential part of the manufacturing of pharmaceutical products. With the draft revision of EU Annex 1, the importance of microbial control strategy and Quality Risk Management is highlighted even more than ever. In this session, a review of a new risk assessment tool for environmental monitoring will be presented with a case study example showing how to implement an EM Program using this tool. In addition, a review of important requirements in steam steriliza-tion will be presented. Controlling, preventing and eliminating contamination is critical to success in pharma manufacturing. Case studies will be presented demonstrating contamination control examples.

11:30 Environmental Monitoring in Modern Biopharmaceutical Drug Product Facilities – A Proposal for a Harmonized Risk-Based Approach to Selecting Monitoring Points and Defining Monitoring Plans

Heike Merget-Millitzer, Janssen J&J

12:00 Moist Heat Sterilization and its Biological Validation: From Rules to Practice

Maria Luisa Bernuzzi, Fedegari Autoclavi

12:30 Case Studies of New Methods of Contamination Elimination and Prevention

Brian G. Hubka, Contamination Prevention Technologies


13:15 Lunch Break, Poster Session & Exhibition


Closing Plenary

Creative Solutions for Contamination Detection & Control

Moderator EU:Moderator US:

Olivier Rocher, GSK VaccinesRenee Blosser, US FDA

For this EU closing session, we will look at alternative solutions to contamination detection & control. Our two speakers are well-known on both continents for their long experience in pharmaceutical microbiology, investigations & troubleshooting, and their passion for alternative micro methods. Dr. Michael Miller will present an overview of the more recent revision of regulations and guidances to define strategies for short-shelf lives medicines such as Cell & Gene Therapy products. Jeanne Moldenhauer will focus on the infamous Burkhoderia cepacia complex and novel methods for eradication of this contamina-tion as well as preventative measures. Those two passionate speakers will enrich their presentations with real case studies.

14:30 Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and Cell Therapy Products

Michael J. Miller, Microbiology Consultants

15:00 Case Studies with Burkholderia Cepacia Complex (BCC) Jeanne Moldenhauer, Excellent Pharma Consulting


16:00 Closing Comments and Farewell Michael J. Miller, Microbiology Consultants, Chair Marsha Steed, ValSource, Co-Chair

Kerstin Wilken, PDA Europe

16:30 End of Conference


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Grand Ballroom Berlin

PDA

POSTER SESSION

CATE

RIN

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Merck

Confarma

Copan

Sanquin

Nelson Labs

PharmigEcolab

Microbiologics

PMM GmbH

Biomérieux

Steris

Veltek

Rapid Micro Biosystems

Charles River

Roche

Elevators

Atrium

StairsCo�ee Station

Co�ee Station

Conference Room

Entrance

FLOOR PLAN

PDA Registration

Table Top 2 m x 3 m (6 m2)

Catering

Poster Session

Validation of the MycoTool Mycoplasma Real-Time PCR Kit

Raphael Greiner,Roche 1

Contamination Control: Bringing Items into the Clean-room

Aaron Mertens, Steris 2

Disinfectant Efficacy Method Development

Brandy Koslop, Ecolab 3

Bioburden Strategy in a Vaccine Manufacturing Unit

Emmanuelle Fort, Odile Leport, GSK 4

Residues: A Major and Rising Consider-ation for Your Clean-room Disinfection Programme

James Tucker, Ecolab Life Sciences 5

Do Microbiological Reference Materials Match their Associ-ated “Certificates Of Analysis”?

Brendan Tindall, BioMérieux 6

PDA Europe Poster Session

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EXHIBITOR ABSTRACTS

bioMérieux Deutschland GmbH Weberstraße 8 72622 Nürtingen, Germany Tel. +49 702 230 070 [email protected] www.biomerieux-industry.com/ twitter.com/bioMerieux_IND de.linkedin.com/company/biomerieux

Developing and producing the largest range of microbial con-trol solutions (reagents, instruments, software and services), bioMérieux Industry provides answers from sample prepara-tion to final identification and typing of microorganisms as well as endotoxin detection solutions based on recombinant Factor C (rFC), completely without using the blood of horse-shoe crabs. ENDONEXT™ endotoxin detection assays from bioMérieux are ushering in a new era of smarter, more sus-tainable pharmaceutical quality control.

Charles River Max-Plank-Straße 15A, 406099 Erkrath, Germany Tel: +800 3195 3430 [email protected] www.criver.com/biologics

With more than 50 years of experience and proven regulato-ry expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic devel-opment cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to mar-keted products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Bio-logics group can create a custom solution to suit their needs.

CONFARMA Zi Est Rue Du Canal d’Alsace 68490 Hombourg, France Tel. +33 389 836 334 [email protected] http://www.confarma.fr/

CONFARMA is an analytical service provider for pharmaceu-tical, biotechnology, medical device, chemical and cosmetic industries. CONFARMA go with you for your methods develop-ment, validations and analysis in biology and physico-chem-istry, according to the highest quality standards. The site is pharmaceutical establishment authorized by ANSM and de-clared complies with GMP and GLP principles. CONFARMA is ISO 9001, 14001, OHSAS 18001, ISO 17025 accredited by COFRAC and approved by FDA. The company know-how is carried in microbiology (sterility, Bioburden, germ count, CCIT, antibiotics ...), biology and cellbiology (LAL, MAT, bioas-says ...), Physico-chemistry (particles, TOC/THC, water analy-sis, pesticides, water activity ...), virology and molecular biolo-gy (microorganisms identification, detection of mycoplasma, residual DNA ...).

Copan Italia Spa Via F. Perotti 10 25125 Brescia, Italy [email protected] www.copangroup.com linkedin.com/company/copan-italia-s.p.a./

With a rightful reputation for innovation, COPAN is the world leading manufacturer of collection and transport systems. In like manner, COPAN’s collaborative approach to pre-analytics has resulted in the development of FLOQSwabs®, ESwab®, UTM® and modular laboratory automation, WASP® and WASPLab®.

Ecolab PO Box 11, Winnington Avenue Northwich, Cheshire, United Kingdom Tel. +44 2920 854390 [email protected] www.ecolablifesciences.com

Ecolab’s Life Sciences division is dedicated to developing the best possible products and services to support our cus-tomers in the industry. Our comprehensive solutions and technical expertise are focused on cleaning, sanitisation and contamination control, all while ensuring safety, compliance and operational efficiency. Our strategy is to stay focused on two core areas: Global Trends and Regulatory Changes that impact your operations, and develop solutions to keep you at the cutting edge.

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EXHIBITOR ABSTRACTS

MERCK KGaA Frankfurter Str. 250 64279 Darmstadt, Germany [email protected] www.merckmillipore.com

The life science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has 19,000 employees and 72 manufacturing sites worldwide, with a portfolio of more than 300,000 products enabling scientific discovery. Merck KGaA, Darmstadt, Germany com-pleted its $17 billion acquisition of Sigma-Aldrich in November 2015, creating a leader in the $130 billion global life science industry. Merck industrial microbial testing solutions for all your needs - offering more than a complete range of high quality microbiology testing solutions for the pharmaceutical, cosmetics, municipal water, beverages and food industries. It’s a comprehensive approach providing regulatory exper-tise, substantial service, and trust. For that one invaluable result: safe products.

Microbiologics Inc 200 Cooper Avenue North, 56303 St Cloud, Minnesota, USA Tel:+ 1 3202531640 [email protected] www.microbiologics.com twitter.com/Microbiologics linkedin.com/company/microbiologics-inc-

Microbiologics is the world’s leading provider of biological references materials for quality control testing. Our portfolio features over 800 microorganism strains which are available in more than 20 unique, easy-to-use configurations including live cultures, inactivated microorganisms, genomic DNA/RNA extracts, synthetic nucleic acid-based materials, and custom-ized solutions. At Microbiologics, our mission is “To provide the highest quality biomaterials for a safer, healthier world.”

Neslon Labs Europe Piet Christiaens Romeinsestraat 12 3001 Heverlee, Belgium Tel. + 32 16 400484 [email protected] www.nelsonlabs.be

Nelson Labs Europe is an independent contract research organization, specialized in providing premium Extractables & Leachables services to the pharmaceutical industry. Based in Belgium, Nelson Labs Europe supports pharmaceutical companies across the globe in developing worldwide compliance testing strategies to qualify Container/Closure Applications and Pharmaceutical Production Equipment from an Extractables & Leachables perspective. Nelson Labs Europe supported over 200 submissions to the FDA and to the EMA. Nelson Labs Europe is ISO 17025 accredited and GLP-certified. Nelson Labs Europe has received a GMP accreditation from the European Authorities. In 2017, Nelson Labs Europe was successfully audited by the FDA.

Pharmig T5 The Maltings, Roydon Road, Stanstead Abbotts SG128HG Hertfordshire, United Kingdom 50933 Cologne, Germany Tel +44 1920 871 999 [email protected] www.pharmig.org.uk

Pharmig is a non-profit professional hub for microbiologists to connect, learn and share expertise. Established in 1991, Pharmig is the leading global community for microbiologists working in the life science and personal healthcare industries. Pharmig provides a focus for continuing professional devel-opment and serves as a unique network for the exchange of information through training courses, conferences, webinars, publications and its’ website. Link: www.pharmig.org.uk

PMM GmbH Gustav-Throm-Str. 1 69181 Leimen , Germany Tel. +49 6224 92 80 70 [email protected] pmm-leimen.de

Pharma Media Dr. Müller GmbH (PMM) was founded in Janu-ary 2013 by Dr. Rolf Müller, who has also founded heipha Dr. Müller GmbH more than 40 years ago. The focus of PMM is the production of high-quality culture media as well as supplying state of the art service to customers of the pharmaceutical industry. The production facility in Leimen, Germany, is espe-cially designed to assure the highest level of security. We have succeeded in manufacturing innovative products which offer a high level of quality and product security. Our product port-folio extends continuously.

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EXHIBITOR ABSTRACTS

Rapid Micro Biosystems 1001 Pawtucket Blvd West, Suite 280 01854 Lowell, MA, USA Tel: ++1 978-349-3200 [email protected] www.rapidmicrobio.com

Rapid Micro Biosystems creates innovative products for fast, accurate, and efficient detection of microbial contamina-tion in the manufacture of pharmaceuticals, biologics, bio-technology products, medical devices, and personal care products. The company’s Growth Direct™ - the first and only growth-based system to automate compendial testing - de-tects microbial contamination more quickly, delivering com-pelling economic benefits to manufacturers while improv-ing their quality control (QC) process. For more information about Rapid Micro Biosystems visit www.rapidmicrobio.com

Roche Diagnostics Deutschland GmbH Sandhofer Strasse 116 68305 Mannheim, Germany Phone: +49 621 759 8816 [email protected] www.roche.de

Building on decades of experience as a diagnostics and phar-maceutical manufacturer, Roche CustomBiotech provides a broad range of products and services for diagnostics, life sciences and pharma biotech industry. Our extensive product portfolio includes enzymes, cofactors, substrates, PCR-based kits for rapid microbiological methods and our Cedex HiRes and Cedex Bio and Cedex Bio HT Analyzers for cell growth and fermentation process monitoring. Get in contact and discuss with us how we can support your goals.

Sanquin Plesmanlaan 125 Amsterdam 1066CX, Netherlands Tel. +31 205 123 599 [email protected] www.sanquin.org/mat

Sanquin’s long lasting research in immunology led by Profes-sor Lucien Aarden, (known as the co-discoverer of IL-6) has formed the basis for the development of the present MAT as-say based on cryopreserved pooled PBMCs and the IL-6 ELISA as cytokine readout. After about 20 years of immune research on monocytes and their cytokine response to pyrogens, the research group teamed up with the Blood Bank, Reagents and Diagnostic Services divisions of Sanquin to further de-velop the MAT into a standardized kit. This collaboration has resulted in a unique setting for the development, production and support of MAT kits and services.

STERIS Life Sciences Eupener Strasse 70 50933 Cologne, Germany Tel +44 7802 397 159 Fax +49 221 466 120 40 [email protected] www.sterislifesciences.com

STERIS Life Sciences provides contamination control solu-tions to the Pharma, Biopharma and Medical Device manu-facturing and R&D sectors on a truly global basis. Our “con-sumables” offering includes a full range of validatable process cleaning agents and antimicrobial products, biological and chemical indicators. They are backed by highly knowledge-able sales team and a data & support package that is unri-valled in the industry. A new and interesting addition to our product offering includes sterilisation wrapping & packaging, covers, closures, bags, liners and cleanroom tools, incorpo-rating all the benefits of Tyvek. In addition to key process equipment such as washers, sterilisers, Water For Injection and Pure Steam Generation systems, our Capital Equipment group offers proprietary VHP decontamination products. These are backed by a fully developed and responsive Service team to correctly maintain the equipment and ensure max-imum up-time. An important service offered is the contract decontamination of manufacturing spaces using our VHP technology, which allows cost effective, validated and rapid preparation of cleanrooms prior to manufacturing. We invite you to visit www.sterislifesciences.com to view your contami-nation control options. Globally.

Veltek Associates, Inc. 15 Lee Blvd 19355 Malvern, Pennsylvania, USA Fax.+1 610-644-8336 [email protected] www.sterile.com

VAI’s manufacturing and testing operations mirror current GMP and GLP standards. We offer a comprehensive line of dis-infectants, sporicides, residue removers, detergents/process cleaners and quality water. A majority of our chemicals are available as sterile pre-saturated wipers in addition to mul-tiple types of dry wipe substrates. A completely redesigned quality garment line with two material types for user com-fort or optimum protection, an innovative line of cleanroom paper, documentation materials, printing systems, cleaning equipment, cart transfer systems, and viable sampling sys-tems; facility wide or portable versions. In addition, VAI pro-vides consulting and laboratory services with over 35 year of contamination control experience.

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PDA Education Program

17-18 October 2018Rapid Microbiological MethodsTwo-Day Training Course

17-18 October 2018Mastering Challenges of Data Integrity and Computer System ValidationTwo-Day Training Course

17-18 October 2018Environmental Monitoring and Contamination ControlTwo-Day Training Course

17-18 October 2018Best Practices and Points to Consider in Aseptic ProcessingTwo-Day Training Course

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TWO-DAY TRAINING COURSE

Rapid Microbiological Methods

Learning Objectives: • Discuss the benefits of alternative and RMM technologies as compared with classical microbiological methods• Describe the scientific basis for a variety of technologies that may be qualified as alternative methods to classi-

cal microbiology procedures; explore case studies and actual workflows for dozens of commercially-available technologies

• Explain the regulatory environment, guidance, policies and expectations for validation, submissions and im-plementation from FDA, EMA, TGA, PMDA, ISO and WHO; understand when and how to change acceptance levels

• Develop business plans and return on investment justifications, follow an actual case study in significant cost savings and cost avoidances by implementing a RMM for environmental monitoring

• Apply industry best practices for validating these new technologies in order to demonstrate that the methods are acceptable for their intended use via IQ, OQ and PQ qualification strategies; understand the differences between PDA TR 33, USP <1223> chapter and Ph. Eur. Chapter 5.1.6

• Appreciate new guidance for rapid sterility testing of advanced therapeutic medicinal products (ATMP; gene and cell therapy) including compendial expectations and regulatory acceptance; justification for sample size allowances and the latest validation strategies

OverviewThis comprehensive course is designed to provide an intensive review of currently available rapid microbiological method (RMM) technologies, validation strategies, applications, regulatory expectations, financial justification mod-els and implementation plans. The use of rapid methods for conventional pharmaceuticals, biotech and short shelf life products, including advanced therapeutic medicinal products (ATMP; gene and cell therapy) will be specifically integrated into the discussions. Taught by one of the industry’s global leaders in rapid methods, the attendee will be immersed in discussions that will provide a meaningful and understandable roadmap for how to evaluate RMMs and employ them in their own laboratory and manufacturing areas.

Who Should Attend: • Departments: Microbiology, Compliance, Engineering, Manufacturing, QA/QC, CMC Documentation,

Regulatory Affairs, Research and Development, Validation, QP• Level of Expertise: Senior Management, Scientists/Technicians• Job Function: Supervisor, Researcher, Analyst, Operative Personnel

Michael J. Miller, PhD, President, Microbiology Consultants, President

Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology, contam-ination control, aseptic processing, sterilization, laboratory design and the validation and implementation of rapid microbiological methods (RMM). He is currently the President of Microbiology Consultants, LLC. For 30 years, he has held numerous R&D, manufacturing, quality, business development and executive leadership roles at multinational firms such as Johnson & Johnson, Eli Lilly and Company and Bausch & Lomb. In his current role, Michael consults with multinational companies in providing technical, quality, regulatory and training solutions in support of RMMs, sterile and non-sterile pharmaceutical manufacturing, contamination control, isolator technology,

environmental monitoring, sterilization and antimicrobial effectiveness. Michael Miller has authored more than 100 technical publications and presentations and is the editor of PDA’s Encyclopedia of Rapid Microbiological Methods and was also the chairperson during the revision of PDA Technical Report #33: Eval-uation, Validation and Implementation of New Microbiological Testing Methods. He currently serves as an advisor to the USP Microbiology Expert Committee in the area of rapid sterility testing. Michael Miller holds a Ph.D. in Microbiology and Biochemistry from Georgia State University (GSU), a B.A. in Anthropology

and Sociology from Hobart College.

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https://pda.org/eu/RMM2018

TRAINING COURSE AGENDA

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Wednesday, 17 October 2018 9:00 – 18:00

9:00 Welcome

9:15 Introduction to RMMs, Applications, Implementation Strategies, Opportunities

Growth-based RMMs; Scientific Principles, Applications and Case Studies

10:30 Coffee Break

11:00 Regulatory Policies and Expectations: FDA, EMA, TGA, PMDA, ISO and WHO

12:30 Lunch Break

13:30 Cellular-component Based RMMs; Scientific Principles, Applications and Case Studies

Viability-based RMMs; Scientific Principles, Applications and Case Studies

15:30 Coffee Break

16:00 Spectroscopic-based RMMs; Scientific Principles, Applications and Case Studies

Genetic and Gene Amplification-based RMMs Part 1; Scientific Principles, Applications and Case Studies

18:00 End of Day 1

Thursday, 18 October 2018 9:00 – 16:30

9:00 Genetic and Gene Amplification-based RMMs Part 2; Scientific Principles, Applications and Case Studies

10:30 Coffee Break

11:00 MEM-based RMMs; The Future of Alternative Technologies

Validation of RMMs Part 1; Due Diligence Activities, Vendor Expectations, IQ, OQ and PQ Strategies, Validation Acceptance Criteria, Use of Statistics

12:30 Lunch Break

13:30 Validation of RMMs Part 2; Equivalence, Method Suitability, Comparison of PDA TR33, USP <1223> and Ph. Eur. 5.1.6

Review of ATMP (gene and cell therapy) expectations for rapid sterility testing according to the revised Ph. Eur. Chapter 2.6.27

A Case Study on Conducting Economic Assessments and Return-on-Investment (ROI) Calculations

15:00 Coffee Break

15:30 References, On-line Resources and Final Remarks

16:30 End of Course

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https://pda.org/eu/RMM2018

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Stefan Wurzer, Global Data Integrity Lead, RocheStefan Wurzer is Global Data Integrity Lead in Pharma Technical Operations at Roche in Basel. He is responsible for the global Data Integrity project, development and sustainment of data integrity standards and trainings, and leads a global network of Data Integrity stewards. He is working in the field of computer system validation since more than 12 years. Prior he worked for Novartis as global eCompliance Manager and as part of this role he was involved in the validation of a globally used SAP system. He holds a bachelor degree in Business Information Systems and is a frequent speaker at conferences.

Stefan Godersky, Consultant, SGMPStefan Godersky has been active in the pharmaceutical industry since 1995 in various positions of development and production depart-ments of Global Players for production sites in Europe and Asia. Now running his own company - he has been a consulting engineer for the medical device and pharmaceutical industry since 2010, with a focus on risk management and validation of computerised systems. Since his degree in process engineering, he has been involved in topics and projects at the interface of software development, pharmaceutical manufacturing processes and quality assurance.

Roberto Bertini, Operations Director, PQEA +18 years long career in Computerized Systems Validation and Data Integrity assurance. Degree in Physics at the University of “La Sapienza” in Rome, he joined PQE in 2000. He is currently Operations Director at PQE for Spain, DACH and CIS Regions, where he is leading the service delivery related to the Business Lines for Data Integrity Assurance. He has managed the validation process of most common Computerized Systems used in the Life Science environment (e.g. ERP, MES, LIMS, WMS, Lab Systems, PCS, Serialization domain) and he has supported the implementation of Quality Management Systems for the IT governance. He is currently supporting a number of pharmaceutical companies in the establishment of Data Integrity Governance and in the resulting Data Integrity Assessment and Remediation.

Faculty

Learning Objectives • Acquire basics about Data Integrity and Computer System Validation• Apply concepts of data integrity on computer system validation• Gain experience through real world examples• Obtain knowledge to deal with the audit trail review challenge• Understand the ideas behind ALCOA• Perform computer system validation by your own

Who Should Attend • Managers responsible for IT systems in pharma and

supplier companies• Validation Managers• Laboratory Supervisors

• Production Supervisors• QA Managers• Everybody, who is involved in the topics of Data Integrity and

Computer System Validation

Overview

Data Integrity is currently a hot topic in the pharmaceutical industry and in the focus of health authority inspections.

A properly validated computer system allows to establish and maintain over time the data integrity: once the regulatory require-ments are met through a consistent and rigorous validation process, this implies that the required controls are in place.

This 2-day training course provides practical guidance to understand the basics of data integrity and computer system valida-tion and offers real world learning examples of integrated approaches. A mixture of lectures and interactive sessions provides a maximum of learning success.

On the first day the focus is on regulatory foundation of data integrity, ALCOA(+) principle, data governance, modelling of data/process flows, and hybrid systems. The second day consists of workshops around risk evaluation and presentation/discussions about general principles of computer system validation and audit trail reviews.

Mastering Challenges of Data Integrity and Computer System Validation


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Wednesday, 17 October 2018 9:00 – 17:159:00 Welcome and Introduction

9:15 Regulatory Update• Essential Requirements / Update Guideline Changes• Inspection Findings / e.g. Warning Letters

10:15 Coffee Break

10:45 “ALCOA +”• General requirements and principals• Interactive session

12:15 Lunch Break

13:15 Code of Conduct / Data Governance

13:45 Data Lifecycle / Data Integrity – Part 1• Presentation of a sample process

14:15 Managing Hybrid Systems• pH-meter, autoclave, HPLC

14:45 Coffee Break

15:15 Data Lifecycle / Data Integrity – Part 2• Interactive Session: Modelling the Process

17:15 End of Day 1

Thursday, 18 October 2018 9:00 – 16:309:00 Recap Day 1

9:15 Data Lifecycle / Data Integrity – Part 3• Interactive session: Risk evaluation, risk mitigation measures

10:45 Coffee Break

11:15 Validation and Data Integrity• Principles of Computer Systems Validation – Software Categories – Validation Approaches• System Validation lifecycle – Simple vs. complex systems • Validation responsibilities and role of suppliers

13:00 Lunch Break

14:00 Validation of commercial software• Data Migration projects• Part 11, Annex 11

14:30 Interactive Session• Risk evaluation of simple vs. complex types

15:15 Coffee Break

15:30 Audit Trail and its Review• Requirements for Audit-Trail • Risk-based approach to the review of Audit Trail

16:00 Wrap-up, Q&A

16:30 End of Course

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Environmental Monitoring and Contamination Control

Marsha Steed, Senior Consultant, ValSourceMarsha Steed has over 25 years of experience as a Microbiologist working in the Pharmaceutical, Biotechnology and Medical Device fields. Marsha has a Bachelors in Biology from Western New England University in Springfield, MA. She is a Senior Consultant for ValSource and in this role, helps companies implement quality risk management into their quality management systems and validation programs. Marsha specializes in helping companies develop risk based environmental monitoring programs and perform microbial risk assessments. She also provides many training courses and webinars for aseptic processing, cleanroom classification and facility start-up. Marsha is an expert in Cell and Gene Therapy. She is active in industry and currently serves on the Parenteral Drug Association (PDA)

Science Advisory Board (SAB) and the Education Advisory Board (EAB). She is member of the PDA Task Force on Microbial Investigations, the PDA Microbiology Program Planning Committee and she has been the past chair of the PDA Annual Meeting. Marsha is a former notified body ISO auditor.

Faculty

Learning Objectives

• Apply current regulatory guidance to your environmental monitoring program and contamination control strategies• Review and discuss the NEW contamination control requirements in the revised Annex 1• Understand the requirements of cleanroom classification and ongoing monitoring according to ISO 14644-1,2• Describe and discuss industry best practice and requirements for establishing cleaning and disinfection programs• Discuss disinfectant efficacy studies• Describe how to implement environmental monitoring risk assessments• Understand differences in EM requirements for non-sterile, low-bioburden, cell and gene therapy and sterile product manufac-

turing• Discuss how to create and perform EM performance qualifications (EMPQ)• Compare and contrast new and existing environmental monitoring equipment• Explain how to conduct EM investigations• Describe how to establish EM alert and action levels and how to prepare meaningful trend reports• Describe and review microbial identification instruments and methods• Understand how to establish the best microbial control strategy for your company

Who Should Attend • Manufacturing - Supervisors/Managers/Specialists• Quality Control - Managers/Specialists/Technicians/

Microbiologists• Quality Assurance - Managers/Specialists/Technicians/

Microbiologists

• Validation - Supervisors/Managers/Specialists/Technicians• Engineering - Supervisors/Managers/Specialists/Technicians

Overview

Establishing a comprehensive microbial control strategy for your company is a key component of contamination control and an expectation of regulatory agencies. This fact is highlighted in the revised version of Annex 1. Contamination control for sterile, non-sterile, low-bioburden and cell and gene therapy manufactured products will all be included in this course with discussions around the differences in each area.

This two-day training course will be a complete review of all aspects of a contamination control program. A review of the regulation and requirements will be performed along with discussions around practical deployment of the requirements as well as challenges and solutions.

This interactive course will provide a detailed review on how to establish and maintain an effective risk based EM Program. Clean-room classification, HVAC Qualification (EMPQ) and routine environmental monitoring requirements and best practices will be dis-cussed along with establishment of cleaning/disinfection programs and disinfectant efficacy testing. EM alert/action level setting, EM excursion investigations and microbial identifications will be discussed.


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Wednesday, 17 Oct 2018 9:00 – 18:00

9:00 Welcome & Introduction

9:15 Guidance and Regulations• FDA Sterile Guidance• Annex 1 2008 and revised version• ISO 14644• USP/EP• PDA TR13 ‘Fundamentals of an

Environmental Monitoring Program’

10:30 Coffee Break

11:00 Classification of Cleanrooms and EMPQ• ISO 14644-1 & 2• Selection of representative sample locations• Use of risk• Periodic classification• Baseline studies• Environmental Monitoring risk assessments• Static and Dynamic EMPQ

12:30 Lunch Break

13:30 Establishing Cleaning and Disinfection Programs• Selecting agents• Mopping• Rotations• Disinfectant Efficacy Studies

15:30 Coffee Break

16:00 EM Risk Assessment Methods• EM-REM• FMEA• HACCP

18:00 End of Day 1

Thursday, 18 Oct 2018 9:00 – 16:30

9:00 Environmental Monitoring Equipment• Sampler types for viable and nonviable• Microbial ID EQ

9:30 Environmental Monitoring (EM)• Non-viable particulates• Viable air and surface• Surface particulates• Personnel EM• Frequency of monitoring• Number of samples• Growth promotion of media• Establishing EM SOPs• In-house vs. CTO options• EMPQ

10:30 Coffee Break

11:00 EM for Different Manufacturing Processes• Sterile Products• Low Bioburden• Non-sterile• Cell and Gene Therapy

12:30 Lunch Break

13:30 EM Trending• Establishing alert and action levels• Meaningful trending and reporting• Use of EM Software

14:30 EM Investigations• Conducting EM Investigations

15:00 Coffee Break

15:30 Microbial Identifications

16:00 Summary, Q&A

16:30 End of Course

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Guenther Gapp, Independent Consultant, Gapp Quality GmbHSince 2013, the microbiologist Guenther Gapp has been working as an independent consultant for different clients around the globe, and has been engaged in more than 30 projects e.g. in assignments for remediation of companies cited with a Warning letter. In the previous steps of his career, he served in the pharmaceutical industry during 20 years as Head of QA/QC Microbiology department and Sterility Assurance Expert and Troubleshooter in global projects and supplier audits. During this period, he gained in-depth experience in Aseptic processing key elements, Training and motivation of operators, media fill practices of finished dosage forms and bulk products, environ-mental monitoring, rapid testing methods and regulatory agency audits. Guenther has been a subject matter expert in more than 20 FDA

audits. He also created a new sterile risk assessment tool to identify and reduce the microbial contamination and compliance risk of aseptically prepared, sterile products, and this method is used now worldwide. The publication of this Risk Assessment tool won him the 2011 PDA Journal of Pharmaceutical Science and Technology Award. He has been a speaker at several PDA conferences in the past years. Since 2017 he has been member of PDA s EU Annex 1 Revision Task Force, Science Advisory Board and Co-Chair in the Isolator Taskforce.

Faculty

Learning Objectives • Gain deeper knowledge and insights into specific topics like sterilization, training and motivation of shop-floor staff, correct aseptic

working practices, media fill worst case criteria, effective environmental monitoring programs, good cleaning & disinfection practices, etc.• Understand key requirements and challenges in parenteral production• Understand the importance of a good quality culture within a company• Apply the executed and presented case studies and team exercises in her/his daily job • Get answers and interpretations about - potentially - unresolved questions and problems• Gain confidence for audits

Overview

Aim of this training course is to facilitate a deeper understanding and provide insights into the Aseptic Processing environment, and to go beyond what is commonly covered in books on that subject. A practical and highly interactive approach will enable participants to get actively involved, discussing guidelines and Warning Letters in addition to sharing perspectives and solu-tions to issues found in everyday job situations.

A kaleidoscope of hot topics such as Best Practices and Case Studies from different areas of Aseptic Processing, Sterile Produc-tion facilities, QA/ QC Microbiology Control, Shop Floor Mentoring and Oversight will be addressed. Training and Motivation of staff, use of Risk Assessments and Quality Culture are further relevant aspects.

Lively interactions will make this a valuable learning experience for all.

Best Practices and Points to Consider in Aseptic Processing

Who Should Attend

• Production Management and Shop Floor Supervisors• QA and QC Microbiologists

• Qualified Persons• Personnel from technical departments

Personnel involved in Aseptic Processing from sterile production departments such as:

A basic understanding of Aseptic Processing is a prerequisite.

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Wednesday, 17 October 2018 9:00 – 17:45

9:00 Welcome and Collection of Participant Expectations

9:30 Introductional Test about Selected Hot Topics in Aseptic Processing• Discussion of answers

10:30 Coffee Break

11:00 Important Aspects of Sterilization, Cleaning and Disinfection, Gowning Procedures• Steam & Dry Heat Sterilization – Technical Report 1 (TR 1) Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification – TR 3 Validation of Dry Heat Processes Used for Depyrogenation and Sterilization – TR 48 Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance – TR 61 Steam in Place• Key elements for Cleaning & Disinfection in cleanrooms – TR 70 Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing• Gowning steps for entering grade A/B area

12:30 Lunch Break

13:30 Aspects of Clean Room Concepts and Good Aseptic Working Practices• Conventional filling lines• RABS systems and isolators• Understanding First Air and barrier concepts – TR 62 Recommended Practices for Manual Aseptic Processes• Points to Consider for Aseptic Processing: Part 1 & Part 2 • Update on TR 34 Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products

14:30 Team Excercise 1: How to Maintain an Aseptic Environment

15:30 Coffee Break

16:00 Effective Oversight at the shop floor, Good Training Methods• Regulatory requirements and framework • Sharing my best practices and effectiveness• Examples from the shop floor worldwide

17:45 End of Day 1

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Thursday, 18 October 2018 9:00 – 16:30

9:00 Best Practices in Aseptic Processing Simulation• Basic Concepts and Regulatory Framework about Process Simulations• Best Practices in Media Fills for Finished Dosage Form and API – TR 22 Process Simulation for Aseptically Filled Products – TR 28 Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals• (Re)Qualification of Operators • Categorization of Interventions

10:00 EU Annex 1 Revision• Selected Comments from the PDA Taskforce

10:30 Coffee Break

11:00 Important Aspects in Environmental Monitoring• TR 13 Fundamentals of an Environmental Monitoring Program• Regulatory requirements and expectations• Rationale for sample locations and frequency• How to proceed in case of excursions

11:30 Team Exercise 2: Set-up a EM Program for Cleanrooms/Isolators

12:30 Lunch Break

13:30 Team Exercise 3: Share your own case studies and problems, and find resolutions as a team

15:00 Coffee Break

15:30 Team Exercise 4: Benchmarking between team members

16:30 End of Course

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V E N U EBerlin Marriott HotelInge-Beisheim-Platz 110785 BerlinGermanyTel: +49 30 22 00 00

CO NTAC T I N FO R M ATI O NConference InquiriesMelanie DeckerDirector Events & [email protected]

Conference Program InquiriesSylvia [email protected]

Registration Customer CareTel: +49 30 [email protected]

Education Program InquiriesElke von [email protected]

Exhibition/Sponsorship Inquiries Nadjeschda Gomez-StahlNadjeschda [email protected]

G E N E R A L A D D R E S SPDA Europe gGmbHAm Borsigturm 6013507 Berlin, GermanyTel: +49 30 4365508-0Fax: +49 30 4365508-66

CO N FE R E N C E R EG I S TR ATI O N H O U R SMonday, 15 October: 8:00 – 18:00Tuesday, 16 October: 8:00 – 13:30

CO U R S E R EG I S TR ATI O N H O U R SWednesday, 17 October: 8:00 – 17:00Thursday, 18 October: 8:00 – 13:00

S PEC I A L R EQU I R E M E NT SIf you require special accommodations to fully par- ticipate, please attach a written description of your

needs with your registration form. Specific questions can be directed to [email protected].

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INFORMATION

Media Partners

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 incur-able and/or debilitating diseases. At Sonnen-hof, 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 confer-ence speakers, PDA has decided to donate this amount to the Sonnenhof Hospice. You can also contribute and help us increase 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


SAVE THE DATEPDA Europe BioManufacturing3 - 4 September 2019

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