PDA FDA 2024

PDA/FDA Joint Regulatory Conference 2024

Current Good Manufacturing Practice (CGMP): Leading with Quality and Integrity

09 - 11 September 2024
Westin Washington, DC Downtown
Washington, DC

Educational Sessions | Interest Groups | Networking Opportunities | Exhibit Area

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  • Peter Marks, MD, PhD

    U.S. FDA

    Director, CBER

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  • Patrizia Cavazzoni, MD

    U.S. FDA

    Director, CDER

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  • Milind Ganjawala, MS, MBA

    U.S. FDA

    Division Director, DDQ2, OMQ, OC, CDER

    Read Bio
  • Janeen Skutnik-Wilkinson

    Moderna, Inc.

    Director, Global Quality, Regulatory Intelligence & External Engagement

    Read Bio

Schedule

Discover What's Happening Each Day
Pre-Agenda08 Sep PDA/FDA Day 109 Sep PDA/FDA Day 210 Sep PDA/FDA Day 311 Sep PDA Workshop11-12 Sep PDA Training12-13 Sep

14:00 – 19:00

Registration Open

15:00 – 18:00

Speaker Ready Room Open

07:00 – 19:30

Registration Open

07:00 – 16:15

Speaker Ready Room Open

07:00 – 08:30

Continental Breakfast

08:00 – 10:00

P1: Opening Plenary

Moderator: Janeen Skutnik-Wilkinson, Director, Global Quality, Regulatory Intelligence & 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 & External Engagement, Moderna

08:30

Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research, U.S. FDA

08:55

Industry Representative Invited

09:20

Q&A

10:00 – 10:45

Networking Break in the Exhibit Area

10:45 – 12:30

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.

10:45

CBER Updates

Peter W. Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, U.S. FDA

11:00

CDER Updates

Regulatory Representative Invited

11:15

CVM Updates

Matthew A. Lucia, DVM, Director, Office of New Animal Drug Evaluation, CVM, U.S. FDA

11:30

ORA Updates

Regulatory Representative Invited

11:45

Q&A

12:30 – 14:00

Lunch on Own

14:00 – 15:30

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.


14:00 | Strategic CAPAs: Beyond Fixes, Expanding Impact Across Operations

Jonathan W. Chapman, MS, Senior Policy Advisor, OC, CDER, U.S. FDA (INVITED)

14:25 | Quality Insights: Proactive Strategies and Preventive Measures for Continuous Improvement

Industry Representative Invited

14:50 | 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.


14:00 | CGMP Guidance and Policy Updates

Tina Kiang, PhD, Director, Division of Regulation, Guidance, and Standards, OPPQ, OPQ, CDER, U.S. FDA (INVITED)

14:25 | Pharmaceutical CGMP Guidance and Policy Updates

Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA

14:50 | Q&A with Additional Panelist

Michael H. Kerrigan, PhD, Supervisory Chemist, ONADE CVM, U.S. FDA (INVITED)

SUPPLY CHAIN

C1: Selecting a Supplier

Moderator: Rick L. Friedman, MS, Deputy Director, OMQ, OC, CDER, U.S. FDA

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. Selection of a reliable CMO (or ingredient supplier) requires strong quality management systems and processes. This session will address not only evaluating the manufacturing competencies of a prospective supplier, but the need to establish trust in the partnership. Elements including auditing, risk assessment, facility capabilities, data integrity, quality system compatibilities, lifecycle risk management, and tailoring quality agreements will be discussed.


14:00 | Supplier Qualification Program: How to Select the Right CMO

Industry Representative Invited

14:25 | Use of Quality Risk Management for Supplier Lifecycle Decision-Making

Eric L. Berg, Interim Quality Site Head, Amgen Inc. (INVITED)

14:50 | Q&A

15:30 – 16:15

Networking Break in the Exhibit Area

16:15 – 17:45

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.


16:15 | 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

16:40 | Assuring Integral Data and Applying Innovative Data Analysis Tools

Shawn Larson, PhD, Development Coordinator, OMPTO, ORA, U.S. FDA (INVITED)

17:05 | Q&A with Additional Panelist

Kevin D. Wojtas, Head, Quality Regulatory Compliance, Takeda (INVITED)

CURRENT PRACTICES AND INNOVATIONS

B2: Sterile Manufacturing Facilities: How QRM Can Help

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.


16:15 | De-Risking Your Aseptic Process

Brooke K. Higgins, MS, Branch Chief, OC, CDER, U.S. FDA

16:40 | Industry Learnings on Sterile Manufacturing Facilities and QRM

Darshana Patel, Associate Director, Micro Quality & Sterility Assurance, Merck & Co., Inc.

17:05 | Q&A with Additional Panelist

Kristen L. Anderson, PhD, Microbiologist, ONADE, CVM, U.S. FDA

SUPPLY CHAIN

C2: Non-Compliant Inspections and PAI Withhold Decisions: Recent Inspectional Findings

Moderator: Erika A. Pfeiler, PhD, Supervisory Microbiologist, 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.


16:15 | OAI Inspections and Defective Drugs

Timothy J. Pohlhaus, PhD, Consumer Safety Officer, OC, CDER, U.S. FDA

16:40 | Pre-License and Pre-Approval Inspectional Trends for Biologics

Madushini N. Dharmasena, PhD, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA (INVITED)

17:05 | Q&A with Additional Panelist

Jonathan G. Swoboda, PhD, Consumer Safety Officer, OCBQ, CBER, U.S. FDA (INVITED)

17:45 – 21:00

Networking Reception

07:00 – 18:00

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: Anchoring Quality Management Maturity to Business Outcomes

Moderator: Patrick J. Lynch, PhD, Lead Biologist, OPQ, CDER, U.S. FDA

FDA’s Center for Drug Evaluation and Research (CDER) is establishing a Quality Management Maturity (QMM) program to promote adoption of mature quality management practices. Case studies in this session will highlight opportunities to leverage the QMM system as a strategic asset that directly contributes to business outcomes. Presenters will also discuss how to assess maturity levels, the steps to evolve quality systems, the impact of QMM systems on reliability of drug supply, and anchoring QMM to business outcomes.

07:15 | Utilizing QMM Systems to Meet Business Goals
Industry Representative Invited

07:40 | Q&A with Additional Panelist
Alex Viehmann, Division Director, OPQ, CDER, U.S. FDA


Breakfast 2: 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 and General Manager, The Society for Sterility Assurance Professionals (INVITED)

07:40 | Q&A with Additional Panelists
Mike J. Sadowski,
Lead Scientist, Baxter Healthcare (INVITED)
Barbara J. Wilimczyk-Macri, MS, Senior Compliance Officer, OMPTO, ORA, 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
Industry Representative Invited

07:40 | Q&A with Additional Panelist
Christina Meissner, PhD, Group Manager, AGES - Austrian Agency for Health and Food Safety GmbH (INVITED)


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
Industry Representative Invited

07:40 | Q&A

08:00 – 10:15

P3: Compliance Office Updates

Moderator: Andrew D. Hopkins, PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie Inc.

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 (INVITED)

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 (INVITED)

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

Moderators: Jackie Veivia-Panter, Consultant and Janeen Skutnik-Wilkinson, Director, Global Quality, Regulatory Intelligence & 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 | Behavior Modification to Drive the Right Quality Culture and Mindset

Industry Representative Invited

11:25 | Quality Behaviors in Action and What Enabled Them

Industry Representative Invited

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 | Industry Perspective on De-Risking Your Quality Control Laboratory

Industry Representative Invited

11:25 | Major Lab Errors and Root Causes Due to Flaws in Lab Test Methods and Equipment

Industry Representative Invited

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, Vice President Quality Assurance, AbbVie Inc. (INVITED)

14:25 | Independence of the Quality Unit Case Study

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 (INVITED)

CURRENT PRACTICES AND INNOVATIONS

B4: Assuring GMPs Through Implementation of Modern Technologies

Moderator: Patrick J. Lynch, PhD, Lead Biologist, 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 (INVITED)

14:25 | Predictive Modeling for Biologics Process Monitoring

Kevin Brower, PhD, Global Head of Purification Development, Sanofi (INVITED)

14:50 | Q&A with Additional Panelists

Christina A. Capacci-Daniel, PhD, Consumer Safety Officer, OMQ, OC, CDER, U.S. FDA (INVITED)
Gang Wang, PhD, Team Lead (Senior Engineer II), Moderna

SUPPLY CHAIN

C4: Cybersecurity Hygiene in Pharma: Lessons from the Digital Battlegrounds

Moderator: Janeen Skutnik-Wilkinson, Director, Global Quality, Regulatory Intelligence & External Engagement, Moderna

Industries around the world face rising cyber threats and the need for robust cybersecurity measures have never been more pronounced. This is especially true for the pharmaceutical sector where data integrity and product quality are paramount. This session will explore the criticality of cybersecurity’s role in the pharmaceutical industry to maintain and enhance the standards of GMP. Using innovative strategies borrowed from unexpected sectors, experts will discuss the various aspects of cybersecurity pertinent to pharmaceutical operations, including data protection, network security, and the integration of secure IoT devices within manufacturing facilities. This session will provide valuable insights that can be adapted to safeguard sensitive pharmaceutical processes.


14:00 | Secure by Design

Regulatory Representative Invited

14:25 | The Intersection of Cybersecurity and Data Integrity

Ash H. Edmondson, Associate Vice President, Security Architecture and Engineering, Eli Lilly and Company (INVITED)

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 Inc.

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

Industry Representative Invited

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 | The “Art of The Possible” by Applying ML/AI in GMP Manufacturing

Ravi Medandravu, MS, Associate Vice President, Manufacturing and Quality Tech, Eli Lilly and Company

16:40 | Digital Twin Applied to Vaccine Manufacturing

Sandrine Dessoy, Science & Technology Innovation Director, GSK (INVITED)

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 | Crafting a Risk-Based Audit Plan with External Intelligence and Logs

Nidia Acevedo, PhD, Senior Vice President Global Quality Compliance, Eli Lilly and Company (INVITED)

16:40 | Overcoming CMO Audit Challenges: Info Sharing, Time, and System Transparency

Industry Representative Invited

17:05 | Q&A with Additional Panelist

Seneca D. Toms, MS, MSEH, RAC, National Expert, Drugs, OMPTO, ORA, U.S. FDA (INVITED)

18:00 – 19:00

Concurrent Interest Group (IG) Sessions

IG1: Data Governance, Management, Integrity, and Digitalization

Leaders

  • Kir Henrici, CEO, The Henrici Group
  • Ulrich Köllisch, Managing Partner, GxP-CC

IG2: Drug Compounding

Leaders

  • Arielle Anahory, MS, Senior Director, XBU Strategy and Customer Excellence, Regulatory Compliance Associates
  • David Short, Chief Quality Officer, QuVa Pharma, Inc.

IG3: Quality Risk Management

Leaders

  • Amanda McFarland, MS, Senior Consultant, ValSource, Inc.
  • Malav Parikh ME, Associate Director, Global Quality Compliance and Systems, Takeda

IG4: Quality Systems

Leaders

  • Ghada Haddad, PhD, Executive Director, Global Quality Shared Services and Regulatory Intelligence, Merck & Co., Inc.
  • Michele Simone, Director, Corporate Quality Compliance, Risk Management & Continual Improvement, Bracco
  • Eva M. Urban, Senior Director, Risk Management, Bristol Myers Squibb

IG5: Regulatory Affairs

Leader

  • Ruhi Ahmed, PhD, RAC, Senior Vice President, FLAG Therapeutics, Inc.

IG6: Technology Transfer

Leaders

  • Mirko Gabriele, PhD, CEO, InfiniteVision
  • Elizabeth Kramer, PhD, Senior Director, Eli Lilly and Company

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
Industry Representative Invited

07:40 | Q&A

Breakfast 6:

Moderator: Paul Z. Balcer, Program Manager, OMQ, OC, CDER, U.S. FDA

07:15 | Hot Topic Discussion
Representative Invited

07:40 | Q&A

Breakfast 7: 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 Technology Case Study
Betty Howard, MBA, Senior Radiation Sterilization Manager, STERIS Applied Sterilization Technologies (AST) (INVITED)

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 (INVITED)

07:55 | Q&A


Breakfast 8: 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 Panelist
Omar Tounekti, PhD, MBA, Manager, Cell, Gene Therapies and Radiopharmaceuticals Division, Health Canada

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 (INVITED)

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 (INVITED)
Ronda R. Loyd-Jones, MBA, Director, Compliance Branch, OPQO, OMPTO, ORA, U.S. FDA (INVITED)

10:00 – 10:30

Networking Break

10:30 – 12:00

P5: Operationalizing Quality Risk Management and Knowledge Management

Moderator: Rick L. Friedman, MS, Deputy Director, 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

Industry Representative Invited

10:55

Operationalizing KM

Industry Representative Invited

11:20

Q&A

12:15 – 13:15

Lunch with the Regulators

Moderator: Rebecca E. Dowd, MS, Director, Investigations Branch, Division 3, OPQO, 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
  • Laura S. Huffman, MS, CVM Pre-Approval Facilities Assessment Program, Lead, ONADE, CVM, U.S. FDA (INVITED)
  • Regulatory Representatives Invited

13:00 – 15:00

P6: Closing Plenary

Moderators: Mary E. Farbman, PhD, Associate Vice President, Global Quality Compliance, Merck & Co., Inc. and Rick L. Friedman, MS, Deputy Director, OMQ, OC, CDER, U.S. FDA

This year’s closing plenary will feature a roundtable of esteemed retired industry leaders sharing their insights and reflections on past challenges and successes. Following this conversation, 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

Panel Discussion

Industry Representatives Invited

14:20

Q&A

14:55

Closing Remarks from the Conference Co-Chairs

Activities and Networking Opportunities

Connect and Collaborate
Tuesday, 10 September 2024

Monuments by Moonlight Trolley 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.

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
  • Denyse Baker, PE, RAC

    Eli Lilly and Company

    AVP Global Quality Compliance

    Read Bio
  • Paul Z. Balcer

    U.S. FDA

    Program Manager, OMQ, OC, CDER

    Read Bio
  • Tara Gooen Bizjak, MBS

    U.S. FDA

    Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER

    Read Bio
  • Francesco Cicirello, PharmD, MSc

    BioNTech

    Senior Director Global BioNTainer Quality Compliance

    Read Bio
  • Daniel DeCiero

    U.S. FDA

    Consumer Safety Officer, OCBQ, CBER

    Read Bio
  • Nicole Deschamps, PhD

    GSK

    Senior Director, External Development Operations and Process Excellence

    Read Bio
  • Rebecca E. Dowd, MS

    U.S. FDA

    Program Division Director, OPQO3, ORA

    Read Bio
  • Mary Farbman, PhD

    Merck & Co., Inc.

    Associate Vice President, Global Quality Compliance

    Read Bio
  • Irving Ford, MSc

    Adaptimmune

    VP of Quality

    Read Bio
  • Rick Friedman, MS

    U.S. FDA

    Deputy Director, OMQ, OC, CDER

    Read Bio
  • Marc Glogovsky, MS

    ValSource, Inc.

    Business Unit Manager - Microbiology

    Read Bio
  • Andrew D. Hopkins, PGDip

    AbbVie Inc.

    Director, Operation Quality QA Audit and Compliance

    Read Bio
  • Mai X. Huynh, MS

    U.S. FDA

    Supervisory Chemist, ONADE, CVM

    Read Bio
  • Al Kentrup

    CISPAC LLC

    Executive VP

    Read Bio
  • Patrick J. Lynch, PhD

    U.S. FDA

    Director, Division of Product Quality Assessment XIII, OPQ, CDER

    Read Bio
  • Ingrid Markovic, PhD

    U.S. FDA

    Senior Science Advisor, Office of the Center Director, ORO, CBER

    Read Bio
  • Erika Pfeiler, PhD

    U.S. FDA

    Supervisory Microbiologist, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER

    Read Bio
  • Jackie Veivia-Panter

    Consultant

    Read Bio
  • Photo coming soon

    Kenneth Nolan

    U.S. FDA

    Senior Advisor

    Bio Coming Soon
  • Photo coming soon

    Lorraine D. Wood, MS

    U.S. FDA

    Health Science Project Manager

    Bio Coming Soon

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Supporters

Supporters and Collaborators
  • Diamond
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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

Cancellation Policy
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.
The Westin Washington DC

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.

 

Rate: $331 plus applicable taxes and fees (currently 15.95%)
Cut-Off Date: Friday, 09 August 2024
How to Get Here
By Air The Westin Washington, DC Downtown is accessible from three major airports: Ronald Reagan Washington National Airport (DCA - approx. 5 miles/8 km), the Washington Dulles International Airport (IAD - approx. 28 miles/45 km), and the Baltimore/Washington International Thurgood Marshall Airport (BWI - approx. 34 miles/55 km).
By Car The Westin Washington, DC Downtown is located at 999 9th Street NW, Washington, DC 20001. Both onsite parking ($48+/day) and valet parking ($65+/day) are available.
By Other Options The Westin Washington, DC Downtown is easily accessible from the following Metro stops: Gallery Place-Chinatown (Green, Red, and Yellow Lines, 7th St. & H St., NW exit - approx. 0.2 miles/0.3 km) and Metro Center (Blue, Orange, Red, and Silver Lines, 11th St. and G St., NW exit - approx. 0.4 miles/0.6 km).

Registration

Pricing Options

Early Registration

Register by 17 July 2024

Member Price

$2,395

GovernmentMember Only

$895

Health AuthorityMember Only

$895

Early Career ProfessionalMember Only

$1,395

StudentMember Only

$595

AcademicMember Only

$895

Non-Member

$2,795

Standard Registration

Register after 17 July 2024

Member Price

$2,895

GovernmentMember 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 Details

Member Price

$2,395

GovernmentMember Only

$895

Health AuthorityMember Only

$895

Early Career ProfessionalMember Only

$1,395

StudentMember Only

$595

AcademicMember Only

$895

Non-Member

$2,795

See Qualifying Criteria for Member Types.

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].


 

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