PDA/FDA Joint Regulatory Conference 2024
Current Good Manufacturing Practice (CGMP): Leading with Quality and Integrity
Educational Sessions | Interest Groups | Networking Opportunities | Exhibit Area
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Benefit from the Annual FDA Co-Sponsored Pharmaceutical CGMP Conference.
Gain in-depth knowledge and practical understanding via focused sessions, interactive discussions, regulatory updates, and case studies regarding the CGMP requirements of the FDA.
CGMP compliance assures maintenance of a daily state of control, and is the foundation for maintaining robust quality, safety, and efficacy of drug products.
Highlighted Presenters
Key Presenters
Conference Co-Chairs
The Minds Behind the Insights
Schedule
Discover What's Happening Each Day
14:00 – 19:00
Registration Open
15:00 – 18:00
Speaker Ready Room Open
07:00 – 19:00
Registration Open
07:00 – 16:15
Speaker Ready Room Open
07:00 – 08:30
Continental Breakfast
08:00 – 09:15
P1: Opening Plenary
Moderator: Janeen Skutnik-Wilkinson, Director, Global Quality, Regulatory Intelligence and External Engagement, Moderna
08:00
Opening Remarks from PDA Leadership and Conference Co-Chairs
- Anil Sawant, PhD, Chair, PDA Board of Directors and Senior Vice President, Merck & Co., Inc.
- Glenn E. Wright, MA, President and CEO, PDA
- Milind Ganjawala, MS, MBA, Co-Chair, PDA/FDA Joint Regulatory Conference 2024 and Division Director, DDQ2, OMQ, OC, CDER, U.S. FDA
- Janeen Skutnik-Wilkinson, Co-Chair, PDA/FDA Joint Regulatory Conference 2024 and Director, Global Quality, Regulatory Intelligence and External Engagement, Moderna
08:30
A Regulatory Perspective on Quality, Integrity, and FDA Modernization
Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research, U.S. FDA
08:55
Q&A
09:15 – 10:15
Networking Break in the Exhibit Area
10:15 – 12:00
P2: Center Office Updates
Moderator: Milind Ganjawala, MS, MBA, Division Director, DDQ2, OMQ, OC, CDER, U.S. FDA
The global regulatory landscape is evolving. How will the U.S. FDA continue to optimize its strategies and actions to accomplish its mission to safeguard the quality, safety, and effectiveness of medicines for patients, even with current manufacturing and supply challenges? After introductory presentations on current Center activities, your questions will be posed to executive managers from various FDA Centers! In a roundtable format, the conversation will focus on these issues that are often cross-cutting across different centers and relevant to the entire pharmaceutical space.
10:15
CBER Updates
Peter W. Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, U.S. FDA
10:30
CDER Updates
Douglas R. Throckmorton, MD, Deputy Director of Regulatory Programs, CDER, U.S. FDA
10:45
CVM Updates
Matthew A. Lucia, DVM, Director, Office of New Animal Drug Evaluation, CVM, U.S. FDA
11:00
ORA Updates
Michael C. Rogers, MS, Associate Commissioner for Regulatory Affairs, ORA, U.S. FDA
11:15
Q&A
12:00 – 13:30
Lunch on Own
13:30 – 15:00
Concurrent Sessions
QUALITY SYSTEMS
A1: CAPA Strategy: Moving from Reactive to Proactive
Moderator: Daniel DeCiero, Consumer Safety Officer, OCBQ, CBER, U.S. FDA
When receiving 483 observations, is your company’s CAPA strategy to do the bare minimum to fix the issue? Do you wait for quality issues to arise instead of being proactive in finding and fixing them? In this session, industry quality professionals and FDA compliance officers will discuss how to be proactive instead of just reacting to issues and observations as they arise. This session will discuss how to 1) assure CGMP compliance by identifying adverse manufacturing and quality signals before they cause failures, and 2) implement effective and proactive CAPAs in response to both 483 observations and internally identified quality risks.
13:30 | Strategic CAPAs: Beyond Fixes, Expanding Impact Across Operations
Jonathan W. Chapman, MS, Senior Policy Advisor, OC, CDER, U.S. FDA
13:55 | Quality Insights: Proactive Strategies and Preventive Measures for Continuous Improvement
Paulien Groll, Head of Compliance Excellence, Takeda
14:20 | Q&A
CURRENT PRACTICES AND INNOVATIONS
B1: CGMP Guidance and Policy Updates
Moderator: Paul Z. Balcer, Program Manager, OMQ, OC, CDER, U.S. FDA
Guidance documents are important tools to provide an insight into FDA regulatory interpretations and stimulate actionable steps to assure quality through robust CGMP compliance. In this session, participants will learn about recent FDA guidance documents that advance public health by promoting improved CGMP compliance and quality.
13:30 | CGMP Guidance and Policy Updates
Tina Kiang, PhD, Director, Division of Regulation, Guidance, and Standards, OPPQ, OPQ, CDER, U.S. FDA
13:55 | Pharmaceutical CGMP Guidance and Policy Updates
Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA
14:20 | Q&A with Additional Panelist
Michael Kerrigan, PhD, Supervisory Chemist, ONADE CVM, U.S. FDA
SUPPLY CHAIN
C1: Effective Management and Maintenance of Contract Operations
Moderator: Marc Glogovsky, MS, Business Unit Manager - Microbiology, ValSource, Inc.
The pharmaceutical industry has continued the marked shift toward reliance on contract manufacturing organizations (CMOs) in recent years. Many companies now obtain most of their drug product supply from CMOs, rather than producing drugs in-house. The selection of a reliable CMO (or ingredient supplier) and establishing a mutual relationship requires strong quality management systems and processes from both parties. This session will address the importance of knowledge management (KM) and quality risk management (QRM) for evaluating the manufacturing competencies of a CMO/supplier, establishing trust, and developing a sustainable partnership. Elements including tailoring quality agreements, auditing, data integrity/data governance, and lifecycle risk management will be discussed.
13:30 | Applying QRM Principles to Navigate Better Outcomes and Partnerships with Your CMO
Douglas A. Campbell, Senior Consultant, InterPro QRA
13:55 | Applications in QRM and KM to Build Trust, Improve Performance, and Enhance CMO Partnership
Martin J. Lipa, PhD, Senior Research Fellow, Technological University Dublin Pharmaceutical Regulatory Science Team
14:20 | Q&A
15:00 – 16:00
Networking Break in the Exhibit Area
16:00 – 17:30
Concurrent Sessions
QUALITY SYSTEMS
A2: Data Integrity and CGMP: Leveraging Digital Tools
Moderator: Al Kentrup, Executive VP, CISPAC LLC
Modern digital capabilities provide great potential to improve problem identification, data analysis, data sharing, cross-disciplinary reviews, quality decision-making, and efficiency. This session will explore how CGMPs and data integrity (DI) will be well served by implementing modern digital strategies. Presenters will address the persistent industry DI issues, focusing on how digital tools could prevent DI problems, while also cautioning to ensure all digital systems are suitable for their intended use. Participants will leave with a better understanding of novel applications of digital tools in production and laboratory settings to enhance CGMP compliance, DI, quality, and efficiency.
16:00 | Prioritizing Root Causes and Enhancing DI with Monte Carlo Failure Mode and Effect Analysis
Paul Hanson, PhD, Vice President, Head of Lifecycle Management, Innovation, and Strategy, Takeda
16:25 | Assuring Integral Data and Applying Innovative Data Analysis Tools
Shawn Larson, PhD, Development Coordinator, OMPTO, ORA, U.S. FDA
16:50 | Q&A with Additional Panelist
Kevin D. Wojtas, Head, Quality Regulatory Compliance, Takeda
CURRENT PRACTICES AND INNOVATIONS
B2: Quality Risk Management Integration in New Sterile Manufacturing Facilities
Moderator: Mai X. Huynh, MS, Supervisory Chemist, ONADE, CVM, U.S. FDA
Aseptic processing has always been known as one of the highest risk processes. An effective quality risk management (QRM) program is essential in aseptic processing facilities, as risk management can be instrumental in identifying and minimizing potential sources of contamination. This session will outline the important aspects of how to initiate and conduct a QRM process for a new aseptic processing facility or process line. Presenters will share case studies and lessons learned in the effective application of QRM principles and tools, including illustrating steps that can be taken to reduce or eliminate hazards in aseptic process design.
16:00 | De-Risking Your Aseptic Process
Brooke K. Higgins, MS, Branch Chief, OC, CDER, U.S. FDA
16:25 | Unlocking the Power of Prevention Controls in QRM to Optimize Aseptic Processing
Darshana Patel, Associate Director, Micro Quality & Sterility Assurance, Merck & Co., Inc.
16:50 | Q&A with Additional Panelists
Kristen L. Anderson, PhD, Microbiologist, ONADE, CVM, U.S. FDA
Robert J. Ham, MEng, Investigator, OMPTO, ORA, U.S. FDA
SUPPLY CHAIN
C2: Non-Compliant Inspections and PAI Withhold Decisions: Recent Inspectional Findings
Moderator: Erika A. Pfeiler, PhD, Supervisory Microbiologist, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER, U.S. FDA
Patients expect, and rely on, safe and effective drug products, which require high-reliability manufacturing. But what happens when circumstances take a different turn? This group of FDA experts will discuss recent notable inspection findings that led to official action indicated (OAI) decisions and product recalls, as well as PAI withhold decisions. Participants in this session will hear case studies on the real-world implications of poor quality and come away with an appreciation of the foundational role of CGMPs in assuring reliable drug quality and availability.
16:00 | OAI Inspections and Defective Drugs
Timothy J. Pohlhaus, PhD, Senior Policy Officer, OC, CDER, U.S. FDA
16:25 | Pre-License and Pre-Approval Inspectional Trends for Biologics
Madushini N. Dharmasena, PhD, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA
16:50 | Q&A with Additional Panelists
Irene E. Abia-Angeh, PharmD, PhD, Chemist, ONADE, CVM, U.S. FDA
Jonathan G. Swoboda, PhD, Consumer Safety Officer, OCBQ, CBER, U.S. FDA
17:30 – 20:30
Networking Reception
07:00 – 19:00
Registration Open
07:00 – 16:45
Speaker Ready Room Open
07:00 – 08:30
Continental Breakfast
07:15 – 08:15
Concurrent Breakfast Sessions
Breakfast 1: Sterility Assurance: The Role of Supply Vendors, Contract Irradiators, and Laboratories
Moderator: Marc Glogovsky, MS, Business Unit Manager - Microbiology, ValSource, Inc.
Sterility combines two processes – irradiation and microbiological assessment. Ancillary products (e.g., gowns and gloves) used in aseptic processing and bio-processing industries must be sterile before use. So how does a drug manufacturer have confidence that these ancillary products meet this requirement? This session will address the standards, activities, controls, logistics, and documentation chain of the processes that deliver sterile products. A panel will also discuss what microbiologists and quality unit personnel can, and should, assess to be confident that these supplies are fit for use.
07:15 | Industry Perspective on Sterility Assurance Roles
Arthur Dumba, Director, The Society for Sterility Assurance Professionals
07:40 | Q&A with Additional Panelists
Mike J. Sadowski, Lead Scientist, Baxter Healthcare
Barbara J. Wilimczyk-Macri, MS, Senior Compliance Officer, OMPTO, ORA,
U.S. FDA
Breakfast 2: Anchoring Quality Management Maturity to Business Outcomes
Moderator: Patrick J. Lynch, PhD, Director, Division of Product Quality Assessment XIII, OPQ, CDER, U.S. FDA
FDA’s Center for Drug Evaluation and Research (CDER) is establishing a Quality Management Maturity (QMM) program to promote the adoption of mature quality management practices that go beyond current GMP requirements. This session will discuss potential advantages of implementing mature quality management practices, assessment of maturity levels, the steps to evolve quality systems, and the impact of QMM practices on business operations and reliability of the drug supply.
07:15 | Utilizing QMM Systems to Meet Business Goals
RJ Doornbos, PharmD, Vice President, Quality Operating Systems and Services, Amgen
07:40 | Q&A with Additional Panelists
Magaly E. Aham, MSc, Senior Director, Quality Compliance, Takeda
Alex Viehmann, Division Director, OPQ, CDER, U.S. FDA
Breakfast 3: Platform Technologies Development, Part 1: GMP and CMC Considerations for Vaccines (RNA)
Moderator: Francesco Cicirello, PharmD, MSc, Senior Director Quality Compliance, BioNTech
Platform technologies are not a new concept per se, however in the last 5-10 years they have come to prominence as an effective way of using prior knowledge to accelerate the introduction of new products especially in the field of RNA medicinal products.
Currently, global regulators from FDA, EMA, WHO, and other agencies are supportive of codifying an approach that would allow streamlined marketing approval of new products that fall within the same manufacturing class. Simultaneously, there are industry led efforts to find the best approach to also apply it to the development phase.
07:15 | Industry Perspective on Platform Technologies for Vaccines
Charalampos Koutsoulas, PharmD, PhD, Director Product Quality, BioNTech SE
07:40 | Q&A with Additional Panelists
Robin Levis, PhD, Deputy Director, Division of Viral Products, OVRR, CBER, U.S. FDA
Christina Meissner, PhD, Group Manager, AGES - Austrian Agency for Health and Food Safety GmbH
Breakfast 4: Is That a Particle? Dealing with Particulates in Cell and Gene Therapies (ATMPs)
Moderator: Daniel DeCiero, Consumer Safety Officer, OCBQ, CBER, U.S. FDA
Explore the critical challenge of particulate contamination in cell and gene therapies (ATMPs). This session will delve into identifying, analyzing, and mitigating particulates to ensure product safety and efficacy. Participants will learn about the latest detection technologies, regulatory requirements, and optimizing practices for contamination prevention. Don’t miss this session addressing one of the most pressing issues in the development and production of advanced therapies!
07:15 | Industry Perspective on Dealing with Particulates in ATMPs
Sarah Bottini, Associate Director, Supplier Quality Supplier Engineer Lead, Bristol Myers Squibb
07:40 | Q&A with Additional Panelists
Stephen E. Langille, PhD, Senior Microbiology Consultant, ValSource, Inc.
John H. Vergara, PhD, Senior Manager, Bristol Myers Squibb
08:00 – 10:15
P3: Compliance Office Updates
Moderator: Andrew D. Hopkins, PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie
Featuring Office of Compliance leaders from the U.S. FDA Centers and Office of Regulatory Affairs, this session continues as one of the highlights of the Conference. In a roundtable format, FDA’s top leaders in compliance and enforcement will describe their programs, initiatives, and recent actions related to inspections and compliance. Regulatory challenges and FDA’s current enforcement strategy for a wide array of medical products will be addressed. This is a great opportunity for participants to understand FDA’s thinking and expectations for industry compliance. In addition, there will be ample time to ask questions of FDA’s senior leadership.
08:30
CBER Compliance Updates
Melissa J. Mendoza, JD, Director, OCBQ, CBER, U.S. FDA
08:45
CDER Compliance Updates
Jill Furman, JD, Director, OC, CDER, U.S. FDA
09:00
CVM Compliance Updates
Cindy L. Burnsteel, DVM, Deputy Director for Drugs and Devices, OSC, CVM, U.S. FDA
09:15
ORA Compliance Updates
Alonza E. Cruse, Director, OPQO, ORA, U.S. FDA (INVITED)
09:30
Q&A
10:15 – 11:00
Networking Break in the Exhibit Area
11:00 – 12:30
Concurrent Sessions
QUALITY SYSTEMS
A3: Aging Facilities: Use of Risk Communication to Address Issues and Ensure Sustainable Product Quality
Moderator: Rebecca E. Dowd, MS, Program Division Director, OPQO3, ORA, U.S. FDA
When it comes to aging facilities, the potential for quality impact-related risks grows over time and may not be readily noticed by those closest to the processes. The risks associated with aging facilities are further compounded when communication streams that enable key stakeholder engagement and decision-making are not fully established. Efforts to stay ahead of aging facility risk require timely communication of information to all relevant parties and decision-makers that are able to implement appropriate action.
In this session, participants will hear from industry leaders on successful aging facility communication paths and the related impact on product quality. Case studies will illustrate the benefits of good facility and equipment communication and the pitfalls when communication channels fail.
11:00 | Industry Perspective on Risk Communication
Nicholas A. Violand, Director, Enterprise Regulatory Compliance, Johnson & Johnson
11:25 | Aseptic Facility Communication and Assessment
Paul R. Palmer, MSc, MBA, Managing Director/Pharmaceutical Consultant, Paul R Palmer Limited
11:50 | Q&A with Additional Panelist
Sandra A. Boyd, Drug National Expert, OMPTO, ORA, U.S. FDA
CURRENT PRACTICES AND INNOVATIONS
B3: Quality Enabling Behaviors
Moderator: Janeen Skutnik-Wilkinson, Director, Global Quality, Regulatory Intelligence and External Engagement, Moderna
Discover how behavior modification principles can drive a quality culture within organizations. This session will include a case study on implementing these techniques and insights from a company that successfully adopted behavior modification programs, such as performance reviews, reward systems, and leadership development, to enhance quality. Learn practical strategies to foster quality-focused behaviors in your organization!
11:00 | Behavioral Changes and Management Strategies: Lessons Learned from Sustainable Procurement
Jane Zhang, MBA, Co-Founder & Co-CEO, ETCH Sourcing
11:25 | Quality Behaviors in Action
Jason Kerr, MBS, MBA, Senior Manager, Global Quality, Regulatory Intelligence and External Engagement, Moderna
11:50 | Q&A
SUPPLY CHAIN
C3: De-Risking Your Quality Control Laboratory
Moderator: Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA
One of the three main objectives of ICH Q10 is to facilitate continual improvement, identify and implement appropriate improvements in product quality, the manufacturing process, reduction in variability, innovation, and pharmaceutical quality system (PQS) enhancement. This is intended to increase the ability to fulfill a manufacturer’s own quality needs consistently. This session will discuss continual reactive and proactive improvement and use of quality risk management (QRM) to identify and prioritize areas of focus of the quality control laboratories. For example, how can we learn from out-of-specification and out-of-trend results and general laboratory errors to improve the overall laboratory system (e.g., equipment, methodology choices, and automation)? Presenters will explore case studies in chemistry and analytical laboratories.
11:00 | Quality Control Laboratory Case Studies
Andrea Sutter Karpinecz, MS, Vice President of Quality Control, Iovance Biotherapeutics
11:25 | Risk-Proofing Science with a Mindset of Quality Always
Aaron R. Goerke, PhD, Site Quality Head, Merck & Co., Inc.
11:50 | Q&A
12:30 – 14:00
Lunch on Own
14:00 – 15:30
Concurrent Sessions
QUALITY SYSTEMS
A4: Independence of the Quality Unit
Moderator: Irving Ford, MSc, VP of Quality, Adaptimmune
Are you independent or is it just an illusion? The Quality Organization must operate independently and have complete autonomy to make decisions. Often, Quality is guided by the demands of “the organization” and decisions are handed to Quality rather than Quality having the final say. If this is the current culture at your organization or an intruder you are trying to stop in its track in your organization, this session will provide information to guide you in your efforts to change the trajectory with robust preventive tactics. Learn how to finally declare your independence and authority!
14:00 | Industry Perspective on Independence of the Quality Unit
Sean McEwen, MEng, Senior Vice President, Quality Assurance & Environmental, Health, and Safety, AbbVie
14:25 | The Case for Global Quality – Compliance and The Bottom Line
Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
14:50 | Q&A with Additional Panelist
Tracy Guldan, MA, Head of Quality Systems, Civica Rx
CURRENT PRACTICES AND INNOVATIONS
B4: Assuring GMPs Through Implementation of Modern Technologies
Moderator: Patrick J. Lynch, PhD, Director, Division of Product Quality Assessment XIII, OPQ, CDER, U.S. FDA
This session will explore recent advances in process modeling for monitoring, control, and validation in GMP. Participants will gain insights into the tech life cycle, focusing on early planning for validation and compliance from development through commercialization and post-marketing. Presenters will share case studies showcasing applications in both small and large molecule processes, highlighting practical implementations and benefits.
14:00 | Chemometrics for Process Control
Chunsheng Cai, PhD, Chemist, OPQ, CDER, U.S. FDA
14:25 | Towards Advanced Process Modeling for Monitoring and Control of Integrated and Continuous Purification
Kevin Brower, PhD, Global Head of Purification Development, Sanofi
14:50 | Q&A with Additional Panelists
Christina A. Capacci-Daniel, PhD, Consumer Safety Officer, OMQ, OC, CDER, U.S. FDA
Gang Wang, PhD, Team Lead (Senior Engineer II), Moderna
SUPPLY CHAIN
C4: Accelerating Robust Manufacturing with Advanced End-To-End Risk Profiling
Moderator: Janeen Skutnik-Wilkinson, Director, Global Quality, Regulatory Intelligence and External Engagement, Moderna
Developing a robust fill-finish manufacturing process often requires complex, time-consuming iterations, with no guarantee of finding the lowest-risk, most scalable option. Manual process design and documentation create bottlenecks, hindering safety and automation efforts. This session will highlight a new approach using computer-generated, end-to-end process design, risk assessment, and documentation to streamline operations, reduce errors, and enhance scalability.
14:00 | Fast-Track to Robust Manufacturing: A Case Study on Frame-by-Frame Process Modeling
Jeff Gensler, MBA, Vice President of Quality, Kindeva Drug Delivery
14:25 | Quantification of Risk Reduction for Robust Manufacturing: A Case Study Addressing ICH Q9(R1) Requirements
Sebastian Scheler, MSc, Managing Director and Chief Methodologist, Innerspace GmbH
14:50 | Q&A
15:30 – 16:15
Networking Break and Passport Drawing in the Exhibit Area
16:15 – 17:45
Concurrent Sessions
QUALITY SYSTEMS
A5: Engaging the Whole Organization in Quality
Moderator: Andrew D. Hopkins, PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie
It’s not you, it’s me! We have all heard the stories – when companies asked who is responsible for quality, the rest of the organization points to the quality unit. This session will show how this culture can be changed and how the rest of the organization can join this journey, and even lead the process! With insights from FDA and senior industry speakers, participants will leave with a better understanding of how this has and can been done, and the impacts when not done properly.
16:15 | Case Study on Engaging the Whole Organization in Quality
Cormac Dalton, PhD, Vice President of Manufacturing (Europe), AbbVie
16:40 | Industry Perspective on Engaging the Whole Organization in Quality
Melissa S. Seymour, MBA, EVP and Chief Quality Officer, Eli Lilly and Company
17:05 | Q&A with Additional Panelist
Kevin J. O’Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority
CURRENT PRACTICES AND INNOVATIONS
B5: Innovations in GMP Compliance: Embracing Digital Technologies in GMP Manufacturing
Moderator: Nicole Deschamps, PhD, Senior Director, External Development Operations and Process Excellence, GSK
Using industry case studies, this session will highlight both the current and potential applications of machine learning/artificial intelligence (ML/AI) and digital twins in GMP manufacturing facilities. The associated regulatory and quality considerations as well as perspectives on future applications and potential challenges with adoption will also be discussed.
16:15 | AI in Manufacturing
Scot Lindsey, Senior Vice President, Information Officer, Manufacturing and Quality, Eli Lilly and Company
16:40 | Digital Twin Applied to Vaccine Manufacturing
Sandrine Dessoy, Science & Technology Innovation Director, GSK
17:05 | Q&A with Additional Panelist
Damodharan Muniyandi, PhD, Chief Quality Officer – Global Quality & Regulatory Affairs, Sai Life Sciences Ltd
SUPPLY CHAIN
C5: Improving Auditing Programs: Going Beyond a Checkbox Approach
Moderator: Denyse D. Baker, PE, RAC, Associate Vice President, Global Quality Compliance, Eli Lilly and Company
Auditing is a key tool in ensuring robust quality systems and processes so that patients receive safe and effective medicines. Audits can also be tremendously resource intensive requiring expert personnel and significant travel time. To maximize the return on that investment and best use learnings gained to ensure continuous improvement, audit findings need to be integrated with overall quality systems and quality practices. This session will explore best practices for a GMP audit program including how to incorporate current external expectations into an audit plan, how to link risk registers to audit planning and outcomes, and how to incorporate audit learnings back into quality procedures or practices.
16:15 | CMO, Partner, and Internal Audits
David Doleski, Compliance Head for Vaccines, Sanofi
16:40 | Enhancing Quality Systems Through Effective Auditing
Nidia Acevedo, PhD, Senior Vice President, Global Quality Compliance, Eli Lilly and Company
17:05 | Q&A with Additional Panelist
Seneca D. Toms, MS, MSEH, RAC, National Expert, Drugs, OMPTO, ORA, U.S. FDA
18:00 – 19:00
Concurrent Interest Group (IG) Sessions
IG1: Technology Transfer
Leaders
- Mirko Gabriele, PhD, CEO, InfiniteVision
- Elizabeth Kramer, PhD, Senior Director, Eli Lilly and Company
- Ghada Haddad, PhD, Executive Director, Global Quality Shared Services and Regulatory Intelligence, Merck & Co., Inc.
- Eva M. Urban, MSc, Senior Director, Risk Management, Bristol Myers Squibb
- Arie Anahory, MS, Senior Director, Strategy and Customer Excellence, Regulatory Compliance Associates Inc.
- David Short, Chief Quality Officer, QuVa Pharma, Inc.
- Julian Petersen, Head of Global Business Development Pharma, groninger & co. gmbh
- Kir F. Henrici, Chief Executive Officer, The Henrici Group
- Ulrich Koellisch, PhD, Partner, GxP-CC GmbH
- Amanda McFarland, MS, Senior Consultant, ValSource, Inc.
- Malav Parikh, ME, Director, Quality Risk Management, Global Quality Compliance and Systems, Takeda
- Ruhi Ahmed, PhD, RAC, Senior Vice President, FLAG Therapeutics, Inc.
IG2: Quality Systems
Leaders
IG3: Drug Compounding AND Sterile Processing/Parenteral Drug Manufacturing
Drug Compounding Leaders
Sterile Processing/Parenteral Drug Manufacturing Leader
IG4: Data Governance, Management, Integrity, and Digitalization
Leaders
IG5: Quality Risk Management
Leaders
IG6: Regulatory Affairs
Leader
07:00 – 15:00
Registration Open
07:00 – 11:00
Speaker Ready Room Open
07:00 – 08:30
Continental Breakfast
07:15 – 08:15
Concurrent Breakfast Sessions
Breakfast 5: Disaster Recovery Planning: Updating Your Contingency Plan
Moderator: Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA
"By failing to prepare, you're preparing to fail." – Benjamin Franklin
A robust contingency and response plan is crucial for disaster event preparation (e.g., tornado, earthquake, etc.). Recently, a tornado caused severe damage to a sterile facility responsible for manufacturing nearly 50 medicines (equating to approximately 8% of the total U.S. hospital supply). This session will focus on the post-disaster responses, how CGMP operations were restarted, and lessons learned for even better preparation for potential future disaster events.
07:15 | Lessons Learned from Rocky Mount
Bryan Timothy Bassler, PhD, Vice President, Sterile Injectable & Biotech Quality Operations Cluster Lead, Pfizer
Breakfast 6: X-Ray Technology
Moderator: Mai X. Huynh, MS, Supervisory Chemist, ONADE, CVM, U.S. FDA
X-ray technology emerged as an alternative to gamma irradiation. How practical and/or reliable is this technology as compared to other means of sterilization? What are the hurdles when considering transitioning from gamma-ray sterilization modalities to X-ray? Using X-ray facility case studies, experts will demonstrate compliance with FDA GMP and the types of testing (e.g., physicochemical, mechanical, extractable testing, etc.,) performed on products to fulfil filing requirements.
07:15 | X-Ray Industry Perspective
Betty Howard, MS, MBA, Senior Radiation Sterilization Manager, STERIS Applied Sterilization Technologies (AST)
07:35 | CDRH Master File Pilot Program to Address Modality Transition and Shortage
Ryan A. Ortega, PhD, Regulatory Policy Advisor, OPEQ, CDRH, U.S. FDA
07:55 | Q&A with Additional Panelist
Irene E. Abia-Angeh, PharmD, PhD, Chemist, ONADE, CVM, U.S. FDA
Breakfast 7: Platform Technologies Development, Part 2: GMP and CMC Considerations for Cell and Gene Therapies (ATMPs)
Moderator: Francesco Cicirello, PharmD, MSc, Senior Director Global BioNTainer Quality Compliance, BioNTech
Platform technologies are not a new concept per se, however in the last 5-10 years they have come to prominence as an effective way of using prior knowledge to accelerate the introduction of new products, especially in the field of cell and gene therapies.
Currently, global regulators from FDA, EMA, WHO, and other agencies are supportive of codifying an approach that would allow streamlined marketing approval of new products that fall within the same manufacturing class. Simultaneously, there are industry led efforts to find the best approach to also apply it to the development phase.
07:15 | Industry Perspective on Platform Technologies for Cell and Gene Therapies (ATMPs)
Markus Gruell, MSc, Vice President Head of Quality, Autolus Ltd.
07:40 | Q&A with Additional Panelists
Kathryn Landes, Vice President Global Product Quality, BioNTech
Omar Tounekti, PhD, MBA, Manager, Cell, Gene Therapies and Radiopharmaceuticals
Division, Health Canada
Breakfast 8: Building a Bridge: Leveraging Data Governance Towards the Adoption of Emerging Technologies
Moderator: Nicole Deschamps, PhD, Senior Director, External Development Operations and Process Excellence, GSK
We live in an exciting time! Digital transformation, data science, and the utility of emerging technologies, like AI, are fueling the life science industry towards endless opportunities to better serve patients globally. In a good practice (GxP) environment, the promise and potential of these innovations share a common essential asset: regulated data. Assuring the integrity of regulated data is a requirement of GxP regulations, leading many organizations to implement formal data governance programs within the quality management system (QMS). This session will address how, in a rapidly evolving and innovative ecosystem, data governance is mission critical, including establishing principles and measures that can be leveraged to build a bridge towards the compliant adoption of emerging technology.
07:15 | Paving the Way for Innovation and Compliance Through Data Governance
Kir F. Henrici, Chief Executive Officer, The Henrici Group
08:30 – 10:00
P4: Current GMP Compliance Trends and Topics
Moderator: Ingrid Markovic, PhD, Senior Science Advisor, Office of the Center Director, ORO, CBER, U.S. FDA
With presentations from CDER and CBER, this can’t miss session will provide more than just the “top ten” 483 observations! Experts will highlight recent trends from violative inspections to enforcement actions giving participants key topics to consider and take back to their team members and colleagues for discussion.
08:30
CDER Updates
Francis RW Godwin, MBA, Office Director, OMQ, OC, CDER, U.S. FDA
08:55
CBER Updates
Daniel DeCiero, Consumer Safety Officer, OCBQ, CBER, U.S. FDA
09:20
Q&A with Additional Panelists
Marea K. Banks, Consumer Safety Officer, OSC, CVM, U.S. FDA
Ronda R. Loyd-Jones, MBA, Director, Compliance Branch, OPQO, OMPTO, ORA, U.S. FDA
10:00 – 10:30
Networking Break
10:30 – 12:00
P5: Operationalizing Quality Risk Management and Knowledge Management
Moderator: Paul Z. Balcer, Program Manager, OMQ, OC, CDER, U.S. FDA
This plenary session will provide practical insight into how quality risk management (QRM) and knowledge management (KM) are being operationalized in pharmaceutical manufacturing. International regulators and industry experts will present principles and tangible examples illustrating how QRM and KM optimize manufacturing processes, reduce errors, and ensure compliance with regulatory standards, ultimately safeguarding patient health and trust in quality of medicines.
10:30
Operationalizing QRM
Kevin J. O’Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority
10:55
Operationalizing KM
Industry Representative Invited
11:20
Q&A with Additional Panelist
Martin J. Lipa, PhD, Senior Research Fellow, Technological University Dublin Pharmaceutical Regulatory Science Team
12:15 – 13:15
Lunch with the Regulators
Moderator: Rebecca E. Dowd, MS, Program Division Director, OPQO3, ORA, U.S. FDA
In this lunch Q&A session, FDA investigators, reviewers, and compliance officers will answer participants’ questions and provide further insights into inspection trends and center initiatives.
Panelists:
- Sandra A. Boyd, Drug National Expert, OMPTO, ORA, U.S. FDA
- Alifiya H. Ghadiali, PhD, RAC, Lead Consumer Safety Officer, OCBQ, CBER, U.S. FDA
- Brooke K. Higgins, MS, Branch Chief, OC, CDER, U.S. FDA
- Laura S. Huffman, MS, CVM Pre-Approval Facilities Assessment Program, Lead, ONADE, CVM, U.S. FDA
- Derek S. Smith, PhD, Deputy Director, OPMA, OPQ, CDER, U.S. FDA
13:30 – 14:30
P6: Closing Plenary
Moderator: Mary E. Farbman, PhD, Associate Vice President, Global Quality Compliance, Merck & Co., Inc.
This year’s closing plenary will feature CBER Director Dr. Peter Marks will close out the Conference with a forward-looking presentation.
13:30
The Evolving Landscape of Pharmaceutical Manufacturing
Peter W. Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, U.S. FDA
13:55
Q&A
14:20
Closing Remarks from the Conference Co-Chairs
PDA 529 Technical Report No. 54: Foundations of Quality Risk Management
12 SepPDA 374 Technical Report No. 22: Process Simulation for Aseptically Filled Products
12 SepPDA 515 The Impact of CGMPs on Biomanufacturing Facility Design and Operation
12 SepPDA 279 Biotechnology: Overview of Principles, Tools, Processes and Products
12 Sep - 13 SepPDA 530 Quality Risk Management: Risk Control and Risk-Based Decision-Making
12 Sep - 13 SepPDA 576 Root Cause Investigation for CAPA
12 Sep - 13 Sep
Activities and Networking Opportunities
Connect and Collaborate
Monuments by Moonlight Trolley Tour
Tuesday, 10 September 2024See DC’s most popular monuments in a different light! On the Monuments by Moonlight Trolley Tour, be transported to many of the city’s most famous sights while enjoying the tranquil night and evening breeze.
Date and time
Tuesday, 10 September / 18:45 – 21:00 ET
Cost
$52 per person, includes private trolley tour and professional live tour guide.
Limit
35 people Max.
About this tour
See DC’s most popular monuments in a different light! On the Monuments by Moonlight Trolley Tour, be transported to many of the city’s most famous sights while enjoying the tranquil night and evening breeze. Along the way, a professional tour guide will take you back in time as they share historic tales and anecdotes about the city’s fascinating history. Learn about the curse of the Hope Diamond and its legacy of death and despair and hear about the Medal of Honor winner who donated his amputated leg to a museum (and often visited it!). You haven’t seen DC until you’ve seen it at night!
Monuments include the Franklin Delano Roosevelt Memorial, the Korean War Veterans Memorial, the Lincoln Memorial, the Marine Corps War Memorial, the Martin Luther King, Jr. Memorial, the Thomas Jefferson Memorial, the United States Capitol, the Vietnam Veterans Memorial, and the Washington Monument.
Timeline
- 18:45 Tour participants meet PDA staff in Westin Washington, DC Downtown lobby
- 19:00 Tour departs from Westin Washington, DC Downtown
- 21:00 Tour returns to Westin Washington, DC Downtown
Program Planning Committee
The Team Behind the Event's Agenda
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Tara Gooen Bizjak, MBS
U.S. FDA
Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER
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Francesco Cicirello, PharmD, MSc
BioNTech
Senior Director Global BioNTainer Quality Compliance
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Nicole Deschamps, PhD
GSK
Senior Director, External Development Operations and Process Excellence
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Patrick J. Lynch, PhD
U.S. FDA
Director, Division of Product Quality Assessment XIII, OPQ, CDER
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Ingrid Markovic, PhD
U.S. FDA
Senior Science Advisor, Office of the Center Director, ORO, CBER
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Erika Pfeiler, PhD
U.S. FDA
Supervisory Microbiologist, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER
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Promotion and Press
Promote the Conference
Get Shareable Images and PostsRequest Press Pass
Submit Your InformationSupporters
Supporters and Collaborators
Diamond Supporter
Platinum Supporter
Silver Supporter
Bronze Supporter
Exhibitors
Exhibitors and Innovators
Media Partners
Location and Travel
Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Conference Venue & Hotel Accommodations
Westin Washington, DC Downtown
999 9th Street, NWWashington, DC 20001, United States
Individual reservations cancelled within seventy-two (72) hours prior to arrival will forfeit one night’s room deposit. Individuals will be responsible for payment of their own cancellation fees.
Discover the vibrant heart of the city at the new Westin Washington, DC Downtown—an energizing gathering place bursting with fresh ideas. Immerse yourself in the allure of iconic experiences, just steps away from the hotel in Washington, DC. From the National Mall to Chinatown, Capital One Arena to the CityCenterDC outdoor shopping area, the best of the city awaits outside the doors. Unwind in inviting guest rooms, featuring the renowned Heavenly® Bed. Ignite your passion in the expansive 10,000 sq. ft. fitness center, the largest in Washington, D.C. Indulge in locally sourced culinary delights that will invigorate your senses. The hotel’s complete transformation has given rise to inspiring spaces, where Westin guests thrive, finding productivity and rejuvenation in perfect harmony.
How to Get Here
Registration
Pricing Options
Standard Registration
Member Price
$2,895GovernmentMember Only
$995
Health AuthorityMember Only
$995
Early Career ProfessionalMember Only
$1,495
StudentMember Only
$695
AcademicMember Only
$995
Non-Member
$3,295
Livestream Registration
Livestream DetailsMember Price
$2,395GovernmentMember Only
$895
Health AuthorityMember Only
$895
Early Career ProfessionalMember Only
$1,395
StudentMember Only
$595
AcademicMember Only
$895
Non-Member
$2,795
GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].
Presenters
MEET OUR PRESENTERS
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Tara Gooen Bizjak, MBS
U.S. FDA
Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER
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Paul Hanson, PhD
Takeda
Vice President, Head of Lifecycle Management, Innovation, and Strategy
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Laura Huffman, MS
U.S. FDA
CVM Pre-Approval Facilities Assessment Program, Lead, ONADE, CVM
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Martin Lipa, PhD
Technological University Dublin Pharmaceutical Regulatory Science Team
Senior Research Fellow
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Christina Meissner, PhD
AGES - Austrian Agency for Health and Food Safety GmbH
Group Manager
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Damodharan Muniyandi, PhD
Sai Life Sciences Ltd
Chief Quality Officer – Global Quality & Regulatory Affairs
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Become a Supporter
Amplify Your Presence and Reach Your Customers!
Become a supporter and/or exhibitor at the only co-sponsored pharmaceutical Current Good Manufacturing Practice (CGMP) conference offered in the United States. As a supporter and/or exhibitor, you'll have unparalleled opportunities to connect with industry leaders, showcase your products and services, and establish your company as a part of the industry.
Become a SupporterLivestream Details
| Conference Elements | In-Person Attendance | Livestream Attendance |
|---|---|---|
| Plenary Sessions | Yes | Yes |
| Concurrent Sessions | Yes | Yes |
| Breakfast Sessions | Yes | Select sessions with audio only |
| Ability to Submit Questions for Q&A | Yes | Yes |
| Lunch with the Regulators | Yes | Yes |
| Interest Group Discussions with FDA Participation | Yes | No |
| Exhibit Hall | Yes | No |
| Monday Evening Networking Reception | Yes | No |
| In-Person Networking with Industry and Regulatory Participants, Presenters, and Panelists | Yes | No |
Have a question or need assistance?
Send us a message, and our team will get back to you shortly. We're here to help!