MONDAY, 12 SEPTEMBER
07:00 – 19:30 | Registration Open
Beat the Monday morning crowd by picking up your badge on Sunday, 11 September from 14:00 – 19:00!
07:00 – 08:30 | Continental Breakfast
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08:00 – 10:00 | P1: Looking to the Future
Moderator: Valerie Whelan, Vice President Quality, Drug Substance Division, Thermo Fisher Scientific
Dr. Peter Marks, FDA’s Director of the Center for Biologics Evaluation and Research, will kick-off the 31st PDA/FDA Joint Regulatory Conference with a presentation on the synergies between science, compliance, quality, and facility capabilities. The second presenter is Susan Hynes, the Senior Vice President of Global Supply Chain Quality at GSK. The presenters will emphasize the bright future ahead of us afforded by adopting and committing to good practices in product development, quality systems, and manufacturing performance throughout the lifecycle.
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08:00 | Welcome and Opening Remarks from PDA Leadership and Conference Co-Chairs
Susan J. Schniepp, Chair, PDA Board of Directors and Distinguished Fellow, Regulatory Compliance Associates Inc.
Richard M. Johnson, MSc, President and CEO, PDA
Rick L. Friedman, MS, Co-Chair, PDA/FDA Joint Regulatory Conference and Deputy Director, OMQ, CDER, U.S. FDA
Valerie Whelan, Co-Chair, PDA/FDA Joint Regulatory Conference and Vice President, Quality, Thermo Fisher Scientific
08:30 | Emerging from Covid: An FDA Perspective
Peter W. Marks, MD, PhD, Director, CBER, U.S. FDA
08:55 | Emerging from Covid: An Industry Perspective
Susan Hynes, MA, Senior Vice President, GSC Quality, GSK
09:25 | Q&A |
10:00 – 10:45 | Refreshment Break in Exhibit Area
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10:45 – 12:15 | P2: What Does Sustainable Compliance Look Like?
Moderator: Rick L. Friedman, MS, Deputy Director, OMQ, CDER, U.S. FDA
This session will address why maintaining compliance with FDA requirements is so important and in the best interests of both manufacturers and patients. Presentations will provide insights into key attributes in organizations that maintain sustainable compliance, including how knowledge-driven systems and a quality assurance foundation lead to durable solutions to complex problems. The patient and business benefits of a persistent focus on a preventive (the “P” in CAPA) mindset throughout operations will be explored. The presenters will ultimately describe how this systemic approach to compliance creates the lifecycle vigilance and adaptability that provides the foundation for consistent quality and supply.
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10:45 | Sustainable Compliance
Donald D. Ashley, JD, Director, Office of Compliance, CDER, U.S. FDA
11:10 | Juan Andres, Chief Technical Operations and Quality Officer, Moderna, Inc.
11:35 | Q&A with Additional Panelist
Francis RW Godwin, MBA, Office Director, OC, CDER, U.S. FDA |
12:30 – 13:30 | Concurrent Interest Group (IG) Sessions
Grab a boxed lunch and bring your comments, questions, and ideas to these interactive IG discussions. Participants will vote on their top discussion topic and then a timed, lively discussion will ensue between the participants, IG leaders, and FDA co-facilitators. When the timer goes off, the group will move on to the next hot discussion topics. IGs are your opportunity to make your voice heard!
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IG1: Biopharmaceutical Manufacturing
- IG Leaders
- Peter J. Makowenskyj, MEng, Director of Design Consulting, G-CON Manufacturing, Inc.
- Toni Manzano, CSO and Co-Founder, Aizon
- FDA Co-Facilitators
- Patricia F. Hughes, PhD, Senior Scientific Advisor, OPQ, CDER, U.S. FDA
- Mai X. Huynh, MS, Supervisory Chemist, CVM, U.S. FDA
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IG2: Lyophilization
- IG Leader: Edward H. Trappler, President, Lyophilization Technology, Inc.
- FDA Co-Facilitator: Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA
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IG3: Quality Risk Management
- IG Leaders
- Amanda McFarland, MS, Senior Consultant, ValSource, Inc.
- Malav Parikh, ME, Associate Director, Global Quality Compliance and Systems, Takeda
- FDA Co-Facilitators
- Paresma R. Patel, PhD, Division Director, OPQ, CDER, U.S. FDA
- Alex M. Viehmann, Division Director, OPQ, CDER, U.S. FDA
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IG4: Technology Transfer
- IG Leader: Beth J. Haas, MChE, Owner/Consultant, Haas Pharma Consulting
- FDA Co-Facilitators
- Rebecca E. Dowd, MS, Supervisory Investigator, ORA, U.S. FDA
- Victor R. Gaines, Branch Chief, OC, CDER, U.S. FDA
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13:45 – 15:15 | Concurrent Sessions
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A1: How Effective Is Your GMP Training?
Moderator: Paul Z. Balcer, Program Manager, OC, CDER, U.S. FDA
Training programs in industry vary in their design but all are intended to meet the CGMP requirement to ensure employees are qualified for their job function. The routine ongoing training program is also often accompanied by ad hoc retraining when a failure is attributed to them. Yet truly effective CAPA should normally include mistake-proofing and not solely stop with retraining an operator. Rethinking training may include adding competencies such as investigations, CAPA, root cause analysis, and design thinking to ensure a set of specialized personnel are able to create resilient solutions by improving systems and design, whenever needed, to prevent recurrence of problems. In this session, we will examine the key features of an effective GMP training program that builds the foundation for GMP compliance and improving training programs and strategies to better support robust quality assurance and state of control.
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13:45 | Human Error = Equipment Failure
James L. Vesper, PhD, MPH, Director, Learning Solutions, Valsource, Inc.
14:10 | After You Rule Out Human Error...
Tracie H. Sharp, MHA, Branch Chief, OC, CDER, U.S. FDA
14:35 | Q&A |
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B1: Speed vs. Quality: Advantages and Pitfalls of Just-In-Time Manufacturing
Moderator: Valerie Whelan, Vice President Quality, Thermo Fisher Scientific
How often have you found yourself in a fire fighting situation with a project, a lot/batch, a customer audit or inspection where you are doing a significant clean up after the fact with a situation that could have been avoided if there had been a greater willingness to slow down, design, and plan properly before you started? As the intensity within our industry and focus on speed-to-market for new therapies continues to increase, the natural inclination is to just try to go faster when, in reality, we need to “go slow to go fast.” In this session, presenters will leverage case studies from industry to demonstrate the value of taking this type of approach versus one focused on speed and share examples from the regulator’s perspective on how robust planning helps ensure success.
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13:45 | Haste Makes Waste: Lessons Learned for How to Avoid a Crisis
Douglas A. Campbell, Senior Consultant, InterPro QRA
14:10 | Speed vs. Quality: An FDA Perspective
Sandra A. Boyd, Drug National Expert, ORA, U.S. FDA (INVITED)
14:35 | Q&A |
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C1: Recently Published Guidances on CGMP and Quality
Moderator: CAPT Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA
New policy, guidance, procedures, oh my! FDA has published many new documents over the past year. In this all-FDA presenter session, participants will hear a high-level overview about new quality guidance. Presentations will also include a case-related dive into the draft Guidance for Industry on Inspection of Injectable Products for Visible Particulates (Dec 2021), to be followed by a multi-center panel Q&A.
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13:45 | What's New in Pharmaceutical Quality (v.2022)
Tina Kiang, PhD, Director, Division of Regulation, Guidance, and Standards, OPQ, CDER, U.S. FDA
14:10 | The Need for the FDA Guidance on Inspection of Injectables for Visible Particulates
Timothy J. Pohlhaus, PhD, Consumer Safety Officer, OC, CDER, U.S. FDA
14:35 | Q&A with Additional Panelists
CDR John W. Diehl, MS, Director, Chief, Medical Products and Tobacco Policy Branch, ORA, U.S. FDA
J. Kevin Rice, PhD, CVM Facilities Assessment Program, CVM, U.S. FDA
Anita F. Richardson, MAS, Associate Director for Policy, OCBQ, CBER, U.S. FDA |
15:15 – 16:00 | Refreshment Break in Exhibit Area
15:25 – 15:55 | Press Conference (Invite Only)
16:00 – 17:30 | Concurrent Sessions
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A2: Human Error: Effectively Resolving the Most Common Cause of Quality Failures
Moderator: Rosemary Orciari, Director Quality, Pfizer
Human error is the most common reason for manufacturing quality failures, but we often stop at addressing this symptom rather than addressing the actual root causes. In this session, practical presentations will detail why training alone is not the answer to human error reduction. Real-life examples will address the roles of risk analysis, process performance monitoring, CAPA, digital tools and continual improvement in minimizing human error and its impact.
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16:00 | Training Won't Fix This
Kenneth A. Whitehead, Vice President - Global Manufacturing Services, Eli Lilly and Company
16:25 | Human Error in GMP: A Regulator's Perspective
Kevin J. O’Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority
16:50 | Q&A with Additional Panelists
Sophia Finckbone, Deviations & CAPA Global Process Owner, GSK
Leah M. Randall, Deviation Manager, AstraZeneca |
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B2: The Digital Automation Revolution: Implementation and Validation
Moderator: Mike G. Labruto, MS, Executive Director, University of Pennsylvania/Gene Therapy Program
Appropriate use of data is critical throughout process development; it helps inform a firm's lifecycle problem recognition, control strategy improvements, risk evaluations, and CAPAs. In this session, participants will hear how the use of artificial intelligence (AI) has been applied within the biopharm process validation stages. The validity and efficiency of the analytical methods employed during the continued process validation (CPV) require extensive knowledge of the process. The challenge for new processes exists as there is limited knowledge available. This will include a case study demonstrating the suitability of methods based on machine learning/artificial intelligence (ML/AI) for the CPV applied across a 5L bioprocess monitoring program and demonstration of cell physiological control. The case study will also include examples and considerations for managing AI using quality systems to ensure the integrity of the data is properly controlled. The second presentation will highlight the aspects of data controls within PDA Technical Report No. 84 (TR 84) Integrating Data Integrity Requirements into Manufacturing & Packaging Operations, including the importance of data criticality. It will also provide recent data from observations related to data integrity/management from recent inspections.
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16:00 | Evolution of Biopharma Processes Rely upon Robust Data Quality: Case Study on Usage of AI in Continued CPV
Toni Manzano, Chief Security Officer, Aizon
16:25 | Agency’s View on Data Criticality and Control Mechanisms to Support Data Integrity Program, Including Recent Data Integrity Observations
Rebecca Parrilla, MS, Compliance Officer/CSO, OMQ, OC, CDER, U.S. FDA
16:50 | Q&A |
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C2: Building Quality into Complex Drug Products
Moderator: Bing Cai, PhD, Division Director, OPQ, CDER, U.S. FDA
This session will focus primarily on building quality into the drug product development throughout the lifecycle management, including product development, manufacturing process design, and quality controls, with tools of risk assessment of critical quality attributes (CQAs) and assurance of reliable supply chain. During this session, participants will learn how this strategy is used for complex drug products and novel continuous manufacturing process features, real-time process control strategy, including rapid assessment of process parameters and material attributes, and adequate control of the product quality and performance. Participants will also learn how to achieve commercial quality readiness and sustainable production with the establishment of a reliable supply chain and business continuity planning. |
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16:00 | Continuous Manufacturing of Liposomes and Lipid Nanoparticles: Control Strategy on the Product Quality
Tony Costa, PhD, Chief Executive Officer, DIANT Pharma Inc.
16:25 | Drug Product Development Technical Review and Stage Processes and the PAI Connection
Eric Thostesen, Senior Director, Regulatory Compliance, Johnson & Johnson
16:50 | Q&A with Additional Panelists
Arwa El Hagrasy, PhD, Associate Director, Regulatory Affairs (CMC), Alnylam Pharmaceuticals
Peter Wojciechowski, PhD, Knowledge Management, Technical Development, Moderna, Inc. |
17:45 – 18:45 | Concurrent Interest Group (IG) Sessions
Bring your comments, questions, and ideas to these interactive IG discussions. Participants will vote on their top discussion topic and then a timed, lively discussion will ensue between the participants, IG leaders, and FDA co-facilitators. When the timer goes off, the group will move on to the next hot discussion topics. IGs are your opportunity to make your voice heard!
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IG5: Data Integrity
- IG Leaders
- Kir F. Henrici, CEO, The Henrici Group
- Ulrich Köllisch, PhD, Manager Data Integrity, GxP-CC
- FDA Co-Facilitators
- Sandra A. Boyd, Drug National Expert, ORA, U.S. FDA
- Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, U.S. FDA
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IG6: Packaging Science
- IG Leaders
- Susan M. Dounce, PhD, Director – Head of Global Product Management, SCHOTT
- Derek I. Duncan, PhD, Director Product Line, Lighthouse Instruments
- FDA Co-Facilitators
- Patricia F. Hughes, PhD, Senior Scientific Advisor, OPQ, CDER, U.S. FDA
- Jeffrey D. Meng, MSE, Program Division Director, OPQO, ORA, U.S. FDA
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IG7: Process Validation
- IG Leader: Mauro Giusti, Senior Director, Site External Network, Eli Lilly and Company and President, PDA Italy Chapter
- FDA Co-Facilitators
- CAPT Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA
- Nicholas A. Violand, Investigator/Drug National Expert, ORA, U.S. FDA
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IG8: Regulatory Affairs & Supply Chain Management
- Regulatory Affairs IG Leader: Ruhi Ahmed, PhD, RAC, Senior Vice President, FLAG Therapeutics Inc.
- Supply Chain Management IG Leader: Lucy M. Cabral, Global Supplier Quality, Genentech, A Member of the Roche Group
- FDA Co-Facilitator: Wei Wang, PhD, Microbiologist, CBER, U.S. FDA
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19:00 – 22:00 | Grand Opening Reception