2022 PDA/FDA Joint Regulatory Conference

12 Sep - 14 Sep 2022
Washington, DC

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The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) are once again co-sponsoring the PDA/FDA Joint Regulatory Conference, which is now in its 31st year. This flagship conference provides opportunities for attendees to learn about current issues relating to manufacturing and quality assurance. The Conference emphasizes the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality. The roles of robust systems, facilities, processes, raw material quality, supplier relationships, industrial modernization, and quality risk management are emphasized. Case studies are presented throughout the conference to provide practical insights into these concepts and illustrate how sustainable compliance establishes the foundation for quality and supply consistency. International collaboration efforts that improve quality and benefit the consumer are also highlighted.
Program Highlights

We're pleased to announce that Shankar Vedantam, host of The Hidden Brain podcast, will be presenting "The Halo Effect: A Discussion" during the closing plenary!

Listen to the Halo Effect Podcast Episode

Shankar Vendantam

Shankar Vedantam
Podcast Host and Creator
The Hidden Brain
Livestream
Conference Elements In-Person Attendance Virtual 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 No
Interest Group Discussions with FDA Participation Yes No
Lunch with the Regulators 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
Register - Livestream

Agenda

Discover What's Happening Each Day
Day 1 12 Sep Day 2 13 Sep Day 3 14 Sep
Monday, 12 September

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

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.

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

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.

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!

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

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

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

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

13:45 – 15:15 | Concurrent Sessions

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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!

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

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

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

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

19:00 – 22:00 | Grand Opening Reception

Tuesday, 13 September

TUESDAY, 13 SEPTEMBER

07:00 – 18:00 | Registration Open

07:00 – 08:30 | Continental Breakfast

07:15 – 08:15 | Concurrent Breakfast Sessions

Breakfast 1: Digital Twins
Moderator: Nicole Deschamps, PhD, Senior Director, Strategic Product Quality, GSK

In this session, participants will gain a fundamental understanding of what digital twins are and an appreciation of their power in accelerating process development, ensuring robust production, and improving quality.

07:15 | Impact and Potential of Digital Twins in The Development and Launch of Medicines and Vaccines
Matt Harrison, Vice President, Projects & Digital Sciences, GSK

07:40 | Q&A

Breakfast 2: GMP at a Distance: The Present and The Future of Remote Regulatory Assessments
Moderator: Xiuju Lu, PhD, Chemist, CBER, U.S. FDA

Are you wondering if your facility is a good candidate for a remote regulatory assessment (RRA)? Want to learn more about different types of approaches regulators use or the best ways to prepare for them? Curious if you should even care about RRAs, now that travel has largely resumed? These questions (and more!) will be addressed in this session where participants will discuss the lessons learned from two years of using this regulatory tool and its utility in the post-pandemic world.

07:15 | International PIC/S Regulatory Perspective on Distant Assessments
Susan Laska, MS, Deputy Chairperson, Pharmaceutical Inspection Co-operation Scheme (PIC/S) and Deputy Assistant Commissioner, OMPTO, ORA, U.S. FDA (INVITED)

07:40 | Q&A with Additional Panelists
Milind Ganjawala, MS, MBA, Division Director, OC, CDER, U.S. FDA
Priscilla María Pastrana López, Consumer Safety Officer, ORA, U.S. FDA
Derek S. Smith, PhD, Deputy Director, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER, U.S. FDA (INVITED)

Breakfast 3: Using Audit Observations to Predict Problems
Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.

Supplier audits, self-audits, regulatory audits, and client audits are all part of any company’s audit program. The normal reaction to observations related to audits is to respond to the auditor with the actions taken to correct the noted observation. The question is: Can we also use the collective observations to try and predict problems that may result in down time, quality issues, or, at worst, drug shortages? This session will explore how to use all the information from the various audits as a predictive tool for potential problems as a part of a comprehensive quality risk management program.

07:15 | Panel Discussion
Bob Buhlmann, Head of Quality Digital Systems, AstraZeneca
CDR John W. Diehl, MS, Chief, Medical Products and Tobacco Policy Branch, ORA, U.S. FDA
Valerie Whelan, Vice President, Quality, Thermo Fisher Scientific

Breakfast 4: Got 483?
Moderator: Jay Jariwala, Senior Director, Regulatory Compliance, Sidley Austin LLP

After receiving an FDA Form 483, Inspectional Observations (FDA-483) companies may wonder, “How should I respond? What should a response contain? How does it affect FDA’s decision making?” In this session, participants will learn what a firm should do after receiving FDA-483 as well as what steps firms should take, including importance of a closeout meeting, how to analyze observations, elements of an effective response, and the importance of responding to verbal observations.

07:15 | The FDA-483: History, Law, and Policy Perspectives
David L. Chesney, MSJ, Principal and General Manager, DL Chesney Consulting, LLC

07:40 | Q&A with Additional Panelist
CAPT Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA

08:30 – 10:15 | Plenary 3: Center Office Updates
Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.

The global regulatory landscape is evolving, and innovative approaches to product life cycle and quality paradigms are met by new real-life challenges and complexities every day – patient-individualized medicines, supply challenges for legacy products, transition to new technologies, highly globalized supply chains. How will the U.S. FDA continue to optimize its mission to safeguard the quality, safety, and effectiveness of medicines for patients even with these manufacturing and supply challenges? After introductory presentations, your questions on these and other issues will be posed to FDA executive management 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.

08:30 | CBER Updates
Peter W. Marks, MD, PhD, Director, CBER, U.S. FDA

08:45 | CDER Updates
Jacqueline Corrigan-Curay, JD, MD, Principal Deputy Center Director, CDER, U.S. FDA

09:00 | CVM Updates
Steven M. Solomon, DVM, MPH, Director, CVM, U.S. FDA

09:15 | ORA Updates
Judith A. McMeekin, PharmD, Associate Commissioner for Regulatory Affairs, ORA, U.S. FDA

09:30 | Q&A

10:15 – 11:00 | Refreshment Break in Exhibit Area

11:00 – 12:45 | Plenary 4: Compliance Office Updates
Moderator: Mary E. Farbman, PhD, Associate Vice President, Global Auditing and Compliance Support, Merck & Co., 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 inspection and compliance. Current regulatory challenges and FDA’s current enforcement strategy for a wide array of medical products will be addressed. This is the best possible opportunity for you to understand FDA’s thinking and expectations for industry compliance. Most importantly, there will be ample time for the audience to ask questions of FDA’s senior leadership.

11:00 | CBER Compliance Updates
Melissa J. Mendoza, JD, Acting Director, Office of Compliance and Biologics Quality, CBER, U.S. FDA

11:15 | CDER Compliance Updates
Donald D. Ashley, JD, Director, Office of Compliance, CDER, U.S. FDA

11:30 | CVM Compliance Updates
Cindy L. Burnsteel, DVM, Deputy Director for Drugs and Devices, Office of Surveillance and Compliance, CVM, U.S. FDA

11:45 | ORA Compliance and Inspectional Activity Updates
Alonza E. Cruse, Director, Office of Pharmaceutical Quality Operations, ORA, U.S. FDA

12:00 | Q&A

12:45 – 14:15 | Portfolio Steering Committee Meeting (Invite Only)

13:00 – 14:00 | 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!

IG9: Cell & Gene Therapy

  • IG Leader: Darius Pillsbury, Senior Consultant, ValSource, Inc.
    FDA Co-Facilitator:
  • Ingrid Markovic, PhD, Senior Science Advisor, Office of the Center Director, CBER, U.S. FDA

IG10: Combination Products & Prefilled Syringes

  • Combination Products IG Leader: Lee Leichter, RAC, MBA, President, P/L Biomedical
  • Prefilled Syringes IG Leader: Olivia A. Henderson, PhD, Principal Engineer, Amgen Inc.
  • FDA Co-Facilitators
    • Bing Cai, PhD, Division Director, OPQ, CDER, U.S. FDA
    • Timothy J. Pohlhaus, PhD, Consumer Safety Officer, OC, CDER, U.S. FDA

IG11: Microbiology/Environmental Monitoring

  • IG Leaders
    • Marc Glogovsky, MS, SM (NRCM), Business Unit Manager/Senior Consultant - Microbiology, ValSource, Inc.
    • Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK
  • FDA Co-Facilitator: Patricia F. Hughes, PhD, Senior Scientific Advisor, OPQ, CDER, U.S. FDA

IG12: Vaccines

  • IG Leaders
    • Jane L. Halpern, Executive Director, IAVI
    • Sabrina Restrepo, PhD, Director, Large Molecules - Technical Product Stewardship, Merck & Co., Inc.
  • FDA Co-Facilitator: Xiuju Lu, PhD, Chemist, CBER, U.S. FDA

14:15 – 15:45 | Concurrent Sessions

A3: Warning Letters and Consent Decree: How to Avoid Them by Staying in Compliance
Moderator: Denise M. DiGiulio, Senior Director, Johnson & Johnson

Are you struggling with an uptick of quality problems and regulatory scrutiny; challenges that can lead to costly regulatory consequences such as a warning letter or worse yet a consent decree? As companies’ product portfolios have become more complex and supply chains more global, regulators have heightened concerns about patient safety, product quality, and drug shortages. This session will discuss insights into preventing the conditions that result in regulatory actions, and why this is far better than reactive and costly remediation. We will leverage a case study from industry to demonstrate a proactive approach to managing quality and compliance risks. An experienced quality executive will share their knowledge, experience, and lessons learned in the remediation of several consent decrees and warning letters. Both topics will demonstrate how putting quality first helps senior leadership transform the quality culture to establish and sustain quality and CGMP compliance for the long haul.

14:15 | Consent Decree Remediation Success, A Sustainable Quality System
Ron Branning, MBA, Chief Executive Officer, GXP Quality Systems, LLC

14:40 | Compliance Premediation
Mary E. Farbman, PhD, Associate Vice President, Global Auditing and Compliance Support, Merck & Co., Inc.

15:05 | Q&A with Additional Panelists
Peter E. Baker, MS, President, Live Oak Quality Assurance
Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, U.S. FDA

B3: Innovative Manufacturing: Pathways to Implementation for Biologics and Biotech
Moderator: Denyse D. Baker, PE, RAC, Senior Director of Global Regulatory Policy, AstraZeneca

The scope of innovative manufacturing can be so much more than continuous processing of tablets. Come to this session for an interactive opportunity to learn about successfully bringing new technology into your biologics and biotech manufacturing operations including gaining regulatory acceptance. Experts will discuss how industry can have early interactions with their CBER Advanced Technology Team (CATT) to de-risk the implementation of advanced technologies, including case studies, and how they are supporting the adoption of new technology through extramural research. Then, the head of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) will share case studies on how the institute is partnering with industry and academic institutions to enable and encourage the adoption of new technology and overcome perceived barriers.

14:15 | The CBER Advanced Technologies Team (CATT): Promoting the Adoption of Advanced Manufacturing Technologies
Manuel Osorio, PhD, Senior Scientist for Emerging Technologies and Medical Countermeasures, CBER, U.S. FDA

14:40 | Accelerating Manufacturing Innovation: Shared Understanding and Going First Together 
Kelvin H. Lee, PhD, Institute Director,  National Institute for Innovation in Biopharmaceutical Manufacturing (NIIMBL)

15:05 | Q&A with Additional Panelist
Lily Y. Koo, PhD, Biomedical Engineer, CBER, U.S. FDA

C3: Contamination Control Strategy: It’s Just Good Business
Moderator: Sharyl D. Hartsock, Associate Vice President, Global Quality Systems, Eli Lilly and Company

The Annex I update has gone through multiple sets of industry review, comment, and revision. One aspect that has remained constant through those updates is the requirement for implementation of a contamination control strategy (CCS). This session will focus on key elements of CCS and highlight how robust application serves as a competitive advantage within the industry. Both agency and industry microbiologists will discuss critical prevention and detection controls to minimize microbial and particulate risk along with an evaluation of effectiveness as part of an overall program aimed at driving continuous improvement. They will also discuss how the CCS enables rapid detection of an issue that may be investigated quickly, to prevent product contamination, in accordance with PDA Technical Report No. 88 (TR 88) Microbial Data Deviation Investigations in the Pharmaceutical Industry.

14:15 | Contamination Control Strategy: Case Study on Microbiological Application
Frederic B. Ayers, Advisor - Global Quality Systems, Eli Lilly and Company

14:40 | Innovative Technologies to Support Contamination Control Strategies
Maik W. Jornitz, MSEng,  President and CEO, G-CON Manufacturing

15:05 | Q&A with Additional Panelists
Thomas J. Arista, Consumer Safety Officer, ORA, U.S. FDA
Rick L. Friedman, MS, Deputy Director, OMQ, CDER,U.S. FDA

15:45 – 16:30 | Refreshment Break and Passport Drawing in Exhibit Area

16:30 – 18:00 | Concurrent Sessions

A4: Pre-Approval Inspections: Facility Deviations, Findings, and FDA 483 Responses
Moderator: Paresma R. Patel, PhD, Division Director, OPQ, CDER, U.S. FDA

In this session, participants will gain familiarity with prior approval inspections and tools utilized by FDA to assess manufacturing facilities, including remote evaluation. An industry case study will be presented along with lessons learned with respect to FDA’s risk-based prior approval inspections of manufacturing facilities.
16:30 | Pre-License and Pre-Approval Inspections for Biologics
Madushini N. Dharmasena, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA

16:55 | Case Study in Resolving Quality Issues: A Small US Drug Manufacturing Company’s Journey from Complete Response to FDA Approval and Beyond
Nicole Oliynyk, Executive Director Regulatory Affairs, Ocular Therapeutix

17:20 | Q&A with Additional Panelists
Michele L. Obert, Pre-Approval Manager, ORA, U.S. FDA
Derek S. Smith, PhD, Deputy Director, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER, U.S. FDA

B4: How ICH Enables Modernization and Innovation
Moderator: Ingrid Markovic, PhD, Senior Science Advisor, Office of the Center Director, CBER, U.S. FDA

International Council for Harmonisation (ICH) has a key role in promoting regulatory convergence of quality standards. Rapid advancements in science and technology, expanding global markets, and the onset of the pandemic underscored the need for convergence working in sync with continuous improvement and innovation, mitigating supply chain vulnerabilities, and enabling patient access to breakthrough therapies.

This session will discuss how ICH helps enable modernization and innovation viewed through the lens of the quality discussion group (QDG). QDG reinforced holistic views of quality risk management and science accommodating advanced technologies and approaches such as automation, isolation, digital technology, AI, modeling, knowledge management through data clouds and structured data formats, portable manufacturing, etc., across ICH quality guidelines and therapeutic modalities.

The session will also discuss current perspectives on ICH Q12 implementation, with a goal of facilitating utilization and realizing the benefits of enhanced science, controls, and quality systems in streamlining post approval change implementation.

16:30 | ICH QDG 2022: Global Harmonization via Improved ICH Implementation
Roger Nosal, MA, Vice President, GCMC, Pfizer

16:55 | FDA Perspective on ICHQ12 Implementation
Mahesh R. Ramanadham, PharmD, MBA, Associate Director Scientific Operations, CDER U.S. FDA

17:20 | Q&A with Additional Panelists
Frank Montgomery, PhD, Vice President CMC RA, AstraZeneca
Kevin J. O’Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority

C4: Managing External Suppliers: Complexities and Knowledge Management
Moderator: Jay Jariwala, Senior Director, Regulatory Compliance, Sidley Austin LLP

Globalization and the need for manufacturing flexibility have given rise to use of external suppliers and contract manufacturing organizations (CMOs) throughout pharmaceutical manufacturing.  The use of CMOs comes with practical risks. Effective governance sees sourcing and managing CMOs as a win-win approach where the benefit of all stakeholders is considered, providing a strategic partner that shares the same quality and patient safety values, rather than a transactional focus. As such, a distributed supply chain amplifies the need for vigilance that ensure that quality exercises throughout the product lifecycle. This session will focus on areas that are essential in cultivating a strong, agile, and sustainable ecosystem of CMOs: a smart supply chain, communication and collaboration to avoid data silos, a strong governance structure, risk management, and data-driven and quality-focused metrics and analytics. Presenters will also discuss strategies firms should consider during selection, managing lifecycle risks, and paradigm shift with strategies and integrated use of highly capable technology for ongoing assurance due to physical supplier audit limitations.

16:30 | Your Suppliers' Risk Is Your Risk: Things to Consider While Developing a Robust Supplier Management Program
Ernest F. Bizjak, Compliance Officer/Acting Team Leader, OMQ, CDER, U.S. FDA

16:55 | Data Driven Supplier Knowledge: Management and Governance
Lisa Gibson, Director of QA – New Site Integration, Thermo Fisher Scientific

17:20 | Q&A with Additional Panelist
Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA

18:00 – 21:00 | PDA Capital Area Chapter Reception

Wednesday, 14 September

WEDNESDAY, 14 SEPTEMBER

07:00 – 15:00 | Registration Open

07:00 – 08:30 | Continental Breakfast

07:15 – 08:15 | Concurrent Breakfast Sessions

Breakfast 5: Reinventing the Efficiency and Reliability of the Microbiology Lab
Moderator: Sharyl D. Hartsock, Associate Vice President, Global Quality Systems, Eli Lilly and Company

There are many opportunities for the microbiology laboratory to transform its often 20th century manual infrastructure by leveraging automation and digitization. The efficiencies and quality advantages of a 21st century laboratory are substantial, including better method reliability, preventing common manual errors, digital capture of data instead of transcription, more efficient batch release, and built-in data integrity security. The presenter will discuss the need to improve microbiology laboratory reliability to assure quality, CGMP compliance, and availability of safe and effective drugs for patients.

07:15 | The Microbiology Lab of the 21st Century: Efficiency and Reliability through Automation and Digitization
Robert Spignesi, MBA, CEO, Rapid Micro Biosystems

07:40 | Q&A with Additional Panelist
Kham Nguyen, Senior Director, Global Field Service and Validation, Rapid Micro Biosystems

Breakfast 6: FDA’s Next Steps in Advancing Quality Metrics and Maturity
Moderator: Denyse D. Baker, PE RAC, Senior Director of Global Regulatory Policy, AstraZeneca

FDA has issued two important publications in 2022 in the area of quality maturity and metrics, 1) an update to the metrics program where FDA has suggested a menu of options for establishments to select, define, and report metrics; and 2) the Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals. Bring your questions to this breakfast session and hear from FDA leaders on the progress with both programs and what are the next steps toward implementation.

07:15 | Advancing Regulatory Oversight: An Overview of Initiatives from the Office of Quality Surveillance
Alex M. Viehmann, Division Director, OPQ, CDER, U.S. FDA

07:40 | Q&A with Additional Panelists
Jean Chung, MS, Chemist, OPQ, CDER, U.S. FDA
Jennifer A. Maguire, PhD, Director, Office of Quality Surveillance, OPQ, CDER, U.S. FDA

Breakfast 7: Achieving Zero Defects
Moderator: Nicole Deschamps, PhD, Senior Director, Strategic Product Quality, GSK

The reduction of visible particles in injectable products is an important element in the consistent delivery of high-quality parenteral products. An important part of this effort is the control of particles that may emanate from the primary packaging materials. The scope of this PDA working group's activities will be discussed, including test and inspection methods, acceptance criterion considerations, and training opportunities.

07:15 | PDA "Achieving Zero Defects for Visible Particles in Injectables" Working Group Update
John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

07:40 | Q&A with Additional Panelist
Ravi Patel, Director, Quality Engineering & Metrology, West Pharmaceutical Services, Inc.

Breakfast 8: Water Systems
Moderator: Mary Farbman, PhD, Associate Vice President, Global Auditing and Compliance Support, Merck & Co., Inc.

Generating and delivering pharmaceutical grade water to our manufacturing processes remains a challenge despite decades of experience with this ubiquitous drug component. In this session, presenters will review case studies of how water system design, control, and maintenance can pose challenges to product quality and to compliance – and how improvements in our water system design, upkeep, and monitoring programs can help protect our products and patients.

07:15 | Water System Design and Maintenance Case Study
Cynthia L. Lake, Executive Director, Merck & Co., Inc.

07:40 | Q&A with Additional Panelist
Rebecca E. Dowd, MS, Supervisory Investigator, ORA, U.S. FDA

08:30 – 10:00 | P5: Current GMP Compliance Trends and Topics
Moderator: David L. Chesney, MSJ, Principal and General Manager, DL Chesney Consulting, LLC

In this perennial “standing room only” session, presenters from CDER and CBER CGMP management will provide insights beyond the usual “Top 10” 483 observations. Attendees will learn about major CGMP issues and notable warning letters.

08:30 | CDER CGMP Update
Francis RW Godwin, MBA, Office Director, OC, CDER, U.S. FDA

08:55 | CBER Compliance Update
Daniel DeCiero, Consumer Safety Officer, CBER, U.S. FDA

09:20 | Q&A with Additional Panelists
Lance M. De Souza, MBA, Director, Compliance Branch, OMPTO, ORA, U.S. FDA
Marea K. Harmon, Consumer Safety Officer, CVM, U.S. FDA

10:00 – 10:45 | Refreshment Break

10:45 – 12:15 | Concurrent Sessions

A5: Strong Investigations and CAPA
Moderator: Mai X. Huynh, MS, Supervisory Chemist, CVM, U.S. FDA

Successful handling of manufacturing and quality problems requires a robust quality system that executes timely actions. Deviations, defects, complaints, and out of specification results are among the areas that require careful investigation to prevent marketed product recalls and supply shortfalls. Participants will learn about root cause analyses, deficiencies noted in audits, developing an effective Corrective and Preventive Actions (CAPA) plan, and how to properly evaluate such actions to incorporate adaptations that safeguard future batch production cycles of the product. This session will also discuss “What, Why, and How,” in order to scope out and close an investigation. Learn how to get all the information you need to correct a quality event and remain compliant.

10:45 | Investigations Related to Media Fills and Sterility Testing
Nicholas A. Violand, Investigator/Drug National Expert, ORA, U.S. FDA (INVITED)

11:10 | A Case Study: Closed Loop Investigation System Ensures Identification and Remediation of True Root Cause
Lori F. Hirsch, JD, Vice President, Regulatory Compliance and External Engagement, Bristol Myers Squibb

11:35 | Q&A with Additional Panelists
Renée S. Blosser, Microbiologist, CVM, U.S. FDA (INVITED)
Rebecca Parrilla, MS, Compliance Officer/CSO, OMQ, OC, CDER, U.S. FDA

B5: Understanding the Capability of Your Facility to Improve Quality Output
Moderator: Rebecca E. Dowd, MS, Supervisory Investigator, ORA, U.S. FDA

Aging facilities and associated risks (“hazards”) therein have been a regulatory focus for many years. The potential impact of these risks on pharmaceutical operations and drug supply are just some of the many affecting consumer confidence and patient safety. Error prevention in equipment, facility, and process design is paramount to ensuring regulatory compliance and reliable supply, yet accurate determination of the root cause of errors can often present a challenge in aging facilities. Through case studies, the presenters will explore example ways to understand the capability of a facility, assess the risks within facilities, leverage existing technologies to modernize operations, and explore innovations that encourage flexibility, reliability, and sustainable compliance.

10:45 | Leveraging Current Technology and Quality Signals to Unlock Bottlenecks in Production while Enhancing Quality Output
Kurt E. Davies, Quality Site Lead, AstraZeneca

11:10 | Proactive Assessment of Equipment Design to Enable Quality Improvements and Reliable Drug Supply
Mark Wittrig, Director of Quality Operations, Pfizer

11:35 | Q&A with Additional Panelist
Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, U.S. FDA

C5: Lifecycle Management of Risks: From Original Application Approval to Post-Approval
Moderator: Patricia F. Hughes, PhD, Senior Scientific Advisor, OPQ, CDER, U.S. FDA

This session will discuss the new FDA assessment tool, Knowledge-aided Assessment and Structured Application (KASA), which is intended to capture and manage knowledge during product lifecycle. KASA is a modernization tool to improve CMC structured data management and should allow for consistent product quality assessments, facilitate the use of new technological and manufacturing advances and improve product supplies during lifecycle. FDA will provide updates on KASA and related PQ/CMC initiatives and discuss progress made on CMC data structuring and use. Examples from industry on how to build CMC structured data for sharing, submission review, and post-approval management will be presented.

10:45 | Role of KASA and Other Related Initiatives (PQ/CMC) to Manage Application Assessments and Post-Approval Lifecycle Management
Lawrence Yu, PhD, Director, Office of New Drug Products, OPQ, CDER, U.S. FDA

11:10 | Industry Perspective on CMC Data Structuring to Manage Knowledge During Product Lifecycle
Michael J. Abernathy, MS, RAC, Executive Director, Regulatory Affairs, Amgen Inc.

11:35 | Q&A

12:30 – 13:30 | Lunch with the Regulators
Moderators: Ingrid Markovic, PhD, Senior Science Advisor, Office of the Center Director, CBER, U.S. FDA and Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.

Grab your boxed lunch and bring questions for U.S. FDA investigators, reviewers, and compliance officers to this Q&A session that will allow for direct input and will provide you with insights regarding inspection trends and center initiatives.

PANELISTS
Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA
Laura S. Huffman, MS, CVM Pre-Approval Facilities Assessment Program, Lead, CVM, U.S. FDA
Jeffrey D. Meng, MSE, Program Division Director, OPQO, ORA, U.S. FDA
Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, U.S. FDA
Derek S. Smith, PhD, Deputy Director, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER, U.S. FDA
Wei Wang, PhD, Microbiologist, CBER, U.S. FDA

13:45 – 14:45 | P6: Moving Forward
Moderator: CAPT Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA

This thought-provoking closing session will discuss how collaboration, innovation, and applying lessons learned to advance industrial quality management are essential to our future success.

13:45 | Moving Forward: The Good, the Bad, and the Ugly
Martin G. VanTrieste, President Emeritus & Board Member, Civica Rx

14:10 | The Halo Effect: A Discussion
Shankar Vedantam, Podcast Host and Creator, Hidden Brain

14:45 | Q&A

15:05 | Closing Remarks from Conference Co-Chairs

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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.

Renaissance Washington, DC Downtown Hotel

999 9th Street, NW
Washington, DC

+1 (202) 898-9000

The Renaissance Washington, DC Downtown hotel is now sold out! While there are no other Conference room blocks, we recommend checking the following hotels for rooms as they are the closest walkable hotels with availability.


 
How to Get Here
By Air Reagan National Airport (DCA) is approximately 5 miles from the Renaissance Washington, DC Downtown hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International Airport (IAD), 27.8 miles away, and Baltimore-Washington International Airport (BWI), 34 miles away. Taxi fares from DCA are approximately $25 one way, not including tip, and will take about 15 minutes. One way taxi fares from IAD is approximately $70 and from BWI about $85.
By Car The Renaissance Washington, DC Downtown hotel is located at 999 9th Street NW, Washington, DC. Parking is available onsite at the following rates: Daily Self Parking - $35; Daily Valet Parking - $60.18

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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 registration@pda.org.

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