PharmaceuticalManufacturing & Quality:

Emerging Regulations and Their Impact

22 - 24 September | Singapore Standard Time (GMT+8)

VIRTUAL CONFERENCE

ASIA PACIFIC

14:00 – 14:10 Welcome & Introduction Richard Johnson, President, PDAMarcel Ewals, Executive Director, PDA Asia PacificBruce Loxley, Steering Committee Chair and President, PDA Singapore Chapter

The regulatory part of the conference will give an update on the upcoming GMP Annex 1 document. An inspector will share the latest version of the document, highlight the new parts and share what the future expectations will be. Industry representatives will summarize the position of the pharmaceutical industry and the trends in international inspections will be shared. Risk management and data handling play a significant role in the new regulations and therefore two presentations will share the essentials.

14:10 – 14:40 Emerging RegulationsThis session gives an update on the new regulations, especially on GMP (Annex 1). What is new, what are the implication on manufacturing and how to implement it. Regulators will give an overview and explain what the new best practices are. Industry experts share their perspective.Moderator: Georg Roessling, Senior Consultant, Business Development Asia, PDA

14:10 – 14:40Regulatory Update: Annex 1 Rico Schulze, GMP Inspector, Saxon State Ministry for Social Affairs and Cohesion

14:40 – 16:25 Implications of The New Guidelines on the Pharmaceutical IndustryThis session continues with discussions and questions. In addition, the perspective of PDA and from the pharmaceutical industry will be given.Moderator: Bruce Loxley, President, PDA Singapore Chapter

14:40 – 15:25 Industry Perspective on Annex 1 Draft Gabriele Gori, Co-Chair of the PDA comment team on Annex 1, GSKDi Morris, Co-Chair of the PHSS comment team on Annex 1, GSK

15:25 – 15:55GMP Inspection Trends – Industry Perspective Yvonne Kwan, Executive Director, Amgen Singapore Manufacturing

15:55 – 16:25 Panel Discussion and Q&A Moderator: Bruce Loxley

16:25 – 16:40 l Sponsor Demonstration – PTI

16:40 – 17:00 l Break

17:00 – 18:30 Quality Risk Management This session´s focus is on quality risk management, a very important aspect of the new regulations. A presentation will show how ICH Q9 became an integral part of the coming Annex1 and how it should be used in a manufacturing environment. The second presentation is related to data handling. PIC/S guideline on Good Practices for Data Management and Integrity will be presented. Most relevant are the aspects data integrity and data criticality assessment.Moderator: Bruce Loxley, President, PDA Singapore Chapter

17:00 – 17:30 QRM and its Application in GMP for Sterile Products’ Stephan Roenninger, Director Quality External Affairs, Amgen (Europe) GmbH

17:30 – 18:00 Data Criticality Assessment, PIC/S PositionDinesh Khokal, Former Regulator at HSA, Singapore, Amgen Biotechnology Singapore

18:00 – 18:30 Panel Discussion and Q&AModerator: Bruce Loxley and Georg Roessling

Pharmaceutical Manufacturing & Quality:Emerging Regulations and Their ImpactTuesday, 22. September – Regulatory | Singapore Standard Time (GMT+8)

The upcoming regulations asks for detailed manufacturing understanding with a risk management of the process, including equipment/machines, IPCs/sensors and personnel activities. Two presentations will address risk-based approaches for maintenance of manufacturing equipment to ensure reliable product quality but also production efficiency and cost advantages. The new requirements for aseptic process simulation, interventions, personnel involvement, and general risk mitigation strategies will be discussed. Finally, the topic of aged facilities will be addressed and potential ways to upgrade such facilities to reach a standard which complies with the new regulations. PDA´s technical reports on these topics will describe the current bestpractices.

14:00 – 15:30 Manufacturing and MaintenanceThe session will demonstrate approaches of maintenance for manufacturing facilities. Proactive maintenance and engineering help avoid unexpected process interventions. How can this be done and what are the advantages for quality, production efficiency and costModerator: Andiyanto Sutandar, Manager, NNIT Singapore

14:00 – 14:30 Setting Calibration Frequencies by a Risk Based Approach: Weibull Probability DistributionJosef Burgmaier, Senior Manager, Asset Management Center, Cilag (JnJ)

14:30 – 15:00 Internal Auditing of Maintenance and CalibrationMichéal O’Hehir, Engineering Compliance Manager, Pharma Supply Chain Engineering, GSK

15:00 – 15:30 Panel Discussion and Q&A Moderator: Andiyanto Sutandar

15:30 – 15:45 l Sponsor Demonstration - Merck

15:45 – 16:00 l Break

16:00 – 18:30 Quality Risk Management (QRM) in ManufacturingThis session will focus on the implementation of risk-based approaches in manufacturing.Moderator: Bruce Loxley, President, PDA Singapore Chapter

16:00 – 16:30 New Requirements for Personnel, Aseptic Processing and Aseptic Process Simulation in Latest Draft Annex 1Goh Choon Wee, Senior Compliance Audit Manager, Roche

16:30 – 17:00 Sampling in an Aseptic Process – Risk Mitigation & Regulatory ComplianceSomasundaram G., Senior Technical Consultant, APAC, Process Solutions, Merck KGaA

17:00 – 17:30 PDA Standard Practice for QRM of Aseptic ProcessingHal Baseman, Chief Operating Officer, Valsource

17:30 – 18:00: Upgrading Aged Facilities and Manufacturing Lines Review of Aging Facilities: The Impact and Further Options Maik Jornitz, President, G-CON, Chair of the PDA Taskforce

18:00 – 18:30 Panel Discussion and Q&AModerator: Bruce Loxley and Georg Roessling

Pharmaceutical Manufacturing & Quality:Emerging Regulations and Their ImpactWednesday, 23. September – Manufacturing | Singapore Standard Time (GMT+8)

For any pharmaceutical manufacturing facility, a robust contamination control strategy is important, and for injectable products especially microbiological aspects are most relevant.

This part of the conference will start with an update of the latest micro chapters of USP. A US FDA regulator will present observations from international GMP inspections and he also will share his thoughts about improvements needed for the future. Environmental Monitoring, control, EM trending and how to apply risk-based approaches in cleaning and disinfection will be the focus of the next session.

The conference will close with a session on new microbiological technologies especially rapid micro methods. What technologies are available and how they can be used will be given in a case study.

09:00 – 10:15 Microbiology in Pharmaceutical ManufacturingThis session gives an overview of regulatory and compendial requirements. Observations of regulatory inspections are presented.Moderator: Georg Roessling, Senior Consultant, Business Development Asia, PDA

09:00 – 09:30 Current Activities and Enhancement Performed by Microbiology Thomas Arista, Field Investigator National Expert Pharmaceutical & Biotechnology, US-FDA

09:30 – 10:15 General Overview of Latest Chapters in USP Micro - Bioburden Characterization, Endotoxins- Rapid Micro QC Methods- Our Ongoing WorkRadhakrishna Tirumalai, Principal Scientific Liaison-General Chapters in the Science Division, USP

10:15 – 10:30 l Sponsor Demonstration - West Pharmaceutical Services, Inc

10:30 – 10:45 l Break

10:45 – 13:25 Environmental Control in Sterile and Non-Sterile FacilitiesIn the Annex 1 draft, it is requested that a contamination control strategy is implemented across the facility. Important elements of that are cleaning and disinfection, monitoring and trending and preventive actions. This session will present examples using risk-based approaches to achieve the regulatory requirements.Moderator: Emily Cheah, Managing Director of Charles River Laboratories Singapore (Microbial Solutions)

10:45 – 11:25 Risk-based Environmental Monitoring Program Ziva Abraham, CEO, Microrite

11:25 – 11:55 A Risk-based Approach to Cleaning & Disinfection Jim Polarine, Senior Technical Service Manager, STERIS Corporation

11:55 – 12:25 Annex 1: Making Sense of EM Microbial Trending and Driving Effective CAPA Plans Ulrich Herber, Director of Technology and Market Development, Charles River Laboratories

12:25 – 13:25Panel Discussion and Q&AModerator: Emily Cheah and Georg Roessling 13:25 – 13:40 l Sponsor Demonstration - Charles River Laboratories

13:40 – 14:30 l Break

14:30 – 16:30 Microbiology/ New Technologies / Rapid Micro MethodsThis session gives insights into new methods to test for microorganism in the manufacturing environment. Technologies of rapid micro-methods will be discussed and a case study will be presented showing the advantages getting microbial test results very quickly.Moderator: Georg Roessling, Senior Consultant, Business Development Asia, Emily Cheah, Managing Director of Charles River Laboratories Singapore (Microbial Solutions)

14:30 – 15:00The Value of Rapid Micro MethodsAndrew Hopkins, Director, Audit Readiness, Abbvie

15:00 – 15:30 Rapid Microbiological Method via ATP-Bioluminescence for Cell & Gene Therapy Products Brice Chasey, Senior Product Manager, Charles River Labs

15:30 – 16:00 Training on Hygiene in Times of Covid -19: What are the New Challenges David Spaulding, Partner/ Training Manager, SeerPharma

16:00 – 16:30 Panel Discussion and Q&AModerator: George Roessling and Emily Cheah

16:30 Closing remarks Georg Roessling, Senior Consultant, Business Development Asia, PDA

Pharmaceutical Manufacturing & Quality:Emerging Regulations and Their ImpactThursday, 24. September – Microbiology | Singapore Standard Time (GMT+8)

BRUCE LOXLEY (GSK)Steering Committee ChairmanBruce performs regional and global auditing of GSK Vaccines and third-party provider sites and functions focusing on the Asia Pacific. Bruce has 29 years in the Pharma and Vaccines businesses, a variety of roles in Validation and Compliance in both Drug Substance and Drug Product Manufacturing in the UK, France, and Singapore.

Bruce has been a PDA Singapore Chapter member since 2014. Since February 2020 he has been PDA Singapore Chapter President.

DR. EMILY CHEAH(CHARLES RIVER LABORATORIES)A registered pharmacist, Dr. Emily Cheah is currently the Managing Director of Charles River Laboratories Singapore (Microbial Solutions). Emily oversees strategic technical operations and market development in Singapore, Malaysia, and Indonesia; and is involved in the implementation of new technology/services at the Singapore site. She also conducts numerous training for the Industry. She received her Ph.D. (Pharm. Technology) from the National University of Singapore and is currently pursuing her EMBA.

Emily is President-Elect of the PDA Singapore Chapter and is an active volunteer with the Chapter since its inception in 2014.

STEERING COMMITTEE

DR. ANDIYANTO SUTANDAR (NNIT)Dr. Andiyanto Sutandar is a Manager in the NNIT Group Life Sciences Divisions of HGP Asia Pte Ltd, Singapore and manages the operations of PT Halfmann Goetsch Partner, Indonesia. Andi leads HGP's Manufacturing Science and Technology service unit. Andi has broad and in-depth experience in technology transfer, risk management, qualification and supply chain management in pharmaceutical industry. Additionally, Andi has expertise indesign and risk management of high containment facilities.

Andi has been a volunteer with PDA Singapore Chapter since 2015 and is currently serving as the Secretary of PDA Singapore Chapter board.

RATNA SOLSIALIN(KALBIO GLOBAL MEDIKA)Ratna Sosialin holds a professional carrier as the Responsible Pharmacist for Quality at various Pharmaceutical Multinational Companies. She started with Pfizer Indonesia in 1991, Roche Indonesia and Bayer Indonesia before moving to a National Company i.e Kalbe Farma in one of the pharma sites, DankosFarma.

Ratna Sosialin is currently the Quality Head of PT. Kalbio Global Medika, a Kalbe company that manufactures bio-tech products both Drug Substances and Drug Products.

Ratna Sosialin was active in a professional organization, namely QA/QC Managers Group for being part of the committee and chairperson for a period. She is also part of the Indonesian GMP experts.

STEERING COMMITTEE

DR. GEORG ROESSLING (PDA)Georg Roessling has been a consultant since 2017. From 2006-2017 he held the position of Sr. Vice President of PDA Europe, where he started the office in Europe and developed a number of conferences and training courses together with regulatory agencies, pharmaceutical industry and suppliers. Before that he worked from 1984-2005 with Schering AG in various positions. These roles included head of pharmaceutical devlopment of parenterals and head of Global CMC Technology office.

Georg is a chemist by training, has a PhD in Physical chemistry from the university of Karlsruhe and was a post-doc in Chemical Engineering in Berkeley, USA. He has been a PDA member for almost 30 years and he received the PDA Honorary Membership.

STEERING COMMITTEE

2020 PDA APAC SINGAPORE SPONSORSPLATINUM SPONSORS

Company Name:CHARLES RIVER LABORATORIES

For more than 70 years, Charles River Laboratories, Inc. has evolved into a worldwide supportnetwork,allowing us to act as a steadfast partner to our clients, from discovery to lot release testing for accelerating drug discovery and development. The Microbial Solutions division strategically built our portfolio to bring you progressive products and services that deliver accurate,relevant and reliable data to fuel confident decisions on product quality and contamination control. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identification and strain typing keeps your manufacturing operations running efficiently and smoothly, lowers your cost to manufacture, andprotects your reputation.

At Charles River we continue to kindle the spark that inspired our founding: an urgency to advance human health by supporting our clients’ research every step of the way.

Company Website: www.criver.com

With the Celsis® detection platform for rapid sterility, we’ve created an unprecedented set

of solutions, features, and options in a package that’s designed for simplicity, not complexity. More

than just an instrument, we’ve partnered with other industry suppliers to create a

complete solution that makes perfect sense.

®

Company Name:MERCK

Merck, a life science leader, is a business of Merck KGaA, Darmstadt, Germany. Our comprehensive portfolio supports customers during all stages of the drug manufacturing process. With our broad range of products, applications and services including single-use manufacturing, filtration, chromatography and purification, virus reduction, pharma and biopharma raw materials, drug delivery compounds, and engineering and validation services we are committed to best support your goals of intensified, connected or continuous bioprocessing. Our industry expertise and regulatory know-how help you get to clinic faster, allowing you to focus on what matters most — delivering safe, effective therapies sooner to the patients that need them most.

Company Website: www.merckmillipore.com

2020 PDA APAC SINGAPORE SPONSORSPLATINUM SPONSORS

MK_AD6566EN 32855 08/2020

Monitor your process with confi dence

NovaSeptum® GO Sterile Sampling SystemA secure and fl exible smart solution for consistent, representative samplesWe understand it is crucial to protect your samples, operators and process during sampling in biopharmaceutical manufacturing. That is why we designed Novaseptum® GO sterile sampling system to minimize risk of cross contamination.

The system provides you with the fl exibility and safety you need when sampling at any point in your aseptic or sterile biomanufacturing process. From the bioreactor to fi nal fi ll, the NovaSeptum® GO sterile sampling system provides you with consistent and representative samples to analyze pH, conductivity, cell viability, and metabolites, as well as monitor bioburden, and endotoxins. Its closed design and security features ensure contamination control and support global regulatory trends including process validation, process analytical technologies (PAT) and quality by design (QbD). A closed, sterile sampling method can signifi cantly reduce your sampling risk and is recommended by regulatory bodies.

Introduce confi dence into your process with Novaseptum® GO sterile sampling system, a solution you can rely on.

Learn more at MerckMillipore.com/SterileSampling

The life science business of Merck operates as MilliporeSigma in the U.S. and Canada.

© 2020 Merck KGaA, Darmstadt, Germany and/or its affi liates. All Rights Reserved. Merck, the vibrant M, Millipore, and NovaSeptum are trademarks of Merck KGaA, Darmstadt, Germany or its affi liates. All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources.

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Company Name:PTI

PTI is a global leader in package quality testing equipment. We specialize in non-destructive testing equipment for high risk packaging applications in the pharmaceutical and medical device industries. With continuous innovation in the space for new drugs and drug delivery systems, PTI manufactures solutions for container closure integrity, package integrity, and seal quality inspection. Our technologies conform to ASTM and other regulatory standards.

Company Website: www.ptiusa.com

2020 PDA APAC SINGAPORE SPONSORSGOLD SPONSORS

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For more information, contact West today. www.westpharma.com

North America 1-800-345-9800 option 8 | South America +55 11 4055 6061 | Europe +49 (0) 2403-7960 | Asia Pacific +65 6862 3400

West and the diamond logo, and FluroTec® are registered trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions. FluroTech technology is licensed from Daikyo Seiko Ltd. Copyright © 2020 West Pharmaceutical Services, Inc. #10313 0617

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Company Name:WEST PHARMACEUTICAL SERVICES

West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept 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 customers from locations in North and South America, Europe, Asia and Australia. West's 2019 net sales of $1.84 billion reflect the daily use of approximately 100 million of its components and devices, which are designed to improve the delivery of healthcare to patientsaround the world.

Company Website: www.westpharma.com

2020 PDA APAC SINGAPORE SPONSORSGOLD SPONSORS

Company Name:STERIS LIFE SCIENCES

STERIS Life Sciences is your trusted partner in contamination control. For over 100 years, STERIS has been a global leader and expert in the industries of sterilization, cleaning, and infection control. Today, we continue to build on this heritage by providing the products and resources you need throughout every step of your process. From innovation to results, our comprehensive portfolio of products and services is designed to meet your needs. Trust STERIS Life Sciences to help you create a healthier and safer world.

Company Website: www.sterislifesciences.com

2020 PDA APAC SINGAPORE SPONSORSEVENT TRACK SPONSOR

Track Sponsor : Microbiology

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