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2021 PDA FDA

2021 PDA/FDA Joint Regulatory Conference

The Roaring 20s: Crisis, Collaboration, Commitment to Quality

Sep 27 - Sep 29, 2021
Eastern Standard Time | Online
  • Virtual
  • Conference
  • Online

Overview

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 30th 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. 

Agenda

  • Day 1
  • Day 2
  • Day 3
  • MONDAY, 27 SEPTEMBER

    09:15 – 11:00 | Plenary 1: Opening Plenary        
    Moderator: Francis RW Godwin, MBA, Director, Office of Manufacturing Quality, CDER, U.S. FDA

    11:00 – 11:30 | Virtual Exhibit Hall Open and Connect & Network

    11:30 – 13:00 | Plenary 2
    Moderator: Valerie Whelan, Vice President, Head of R&D Quality and Compliance, Amgen Inc.

    13:00 – 13:30 | Virtual Exhibit Hall and Connect & Network

    13:30 – 15:00 | Concurrent Sessions

    QUALITY ASSURANCE & QMS

    A1: Aging Facilities vs. Modern Facilities
    Moderator: Christina Y. Scully, MS, Vice President, Internal Manufacturing & Supply Chain Quality, Bristol Myers Squibb

    SUPPLY CHAIN & MANUFACTURING CHALLENGES

    B1: Supply Chain Collaboration and Product Approvals during a Pandemic
    Moderator: Paul Z. Balcer, Consumer Safety Officer, CDER, U.S. FDA

    EMERGING TRENDS & INNOVATION

    C1: Biologics Hot Topics
    Moderator: Ingrid Markovic, PhD, Senior Science Advisor, Office of the Center Director, CBER, U.S. FDA

    15:00 – 15:30 | Virtual Exhibit Hall and Connect & Network

    15:30 – 17:00 | Ask the Regulators 

    U.S. FDA investigators, reviewers, and compliance officers will answer your questions in this Q&A session that will provide you with insights regarding current topics and initiatives.
  • TUESDAY, 28 SEPTEMBER

    08:30 – 09:30 | Special Topic Sessions

    09:30 – 09:45 | Break

    09:45 – 11:15 | Plenary 3: Compliance Office Updates
    Moderator: John D. Ayres, MD, Risk Assessment Clinician, Pharma Safety Solutions, LLC

    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 virtual Roundtable format, U.S. 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 U.S. FDA’s thinking and expectations for industry compliance. Most importantly, there will be ample time for the audience to ask questions of U.S. FDA’s senior leadership.

    11:15 – 11:45 | Virtual Exhibit Hall and Connect & Network

    11:45 – 13:15 | Plenary 4: Current GMP Compliance Trends and Topics
    Moderator: David L. Chesney, MSJ, Principal and General Manager, DL Chesney Consulting, LLC

    New this year as a plenary, this perennial “standing room only” session will include presentations from CDER and CBER CGMP managers that are designed to provide insights beyond the usual “Top 10” 483 observations. Attendees will learn about major CGMP issues and notable warning letters. These presentations will be followed by a discussion with Center and ORA panelists.

    13:15 – 13:30 | Break

    13:30 – 15:00 | Concurrent Sessions

    QUALITY ASSURANCE & QMS

    A2: Non-Sterile Drug Products: Microbial Risks
    Moderator: Pahala Simamora, PhD, Division Director, OPQ, CDER, U.S. FDA

    SUPPLY CHAIN & MANUFACTURING CHALLENGES

    B2: Supplier Oversight
    Moderator: Keduo Qian, PhD, Chemist, CDER, U.S. FDA

    EMERGING TRENDS & INNOVATION

    C2: Drug Quality Lifecycle: Current Regulatory Concerns
    Moderator: Patricia F. Hughes, PhD, Senior Scientific Advisor, CDER, U.S. FDA


    15:00 – 15:30 | Virtual Exhibit Hall and Connect & Network

    15:30 – 17:00 | Concurrent Sessions

    QUALITY ASSURANCE & QMS

    A3: Quality Systems: How to Ensure Resilience and Effectiveness
    Moderator: Denise M. DiGiulio,
    Senior Director, Johnson & Johnson

    SUPPLY CHAIN & MANUFACTURING CHALLENGES

    B3: Manufacturing during and after the Pandemic
    Moderator: Mary E. Farbman, PhD,
    Executive Director, Global Quality Compliance, Merck & Co., Inc.

    EMERGING TRENDS & INNOVATION

    C3: Improving Manufacturing via Modern Technology
    Moderator: Rebecca E. Dombrowski, MS,
    Supervisory Investigator, ORA, U.S. FDA

  • WEDNESDAY, 29 SEPTEMBER

    08:30 – 09:30 | Special Topic Sessions

    09:30 – 09:45 | Break

    09:45 – 11:15 | Plenary 5: Center 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 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 senior management officials from various FDA Centers! In a virtual round table format, the conversation will focus on these issues that are often cross-cutting across different centers and relevant to the entire pharmaceutical space. 

    11:15 – 11:45 | Virtual Exhibit Hall and Connect & Network

    11:45 – 13:15 | Concurrent Sessions

    QUALITY ASSURANCE & QMS

    A4: Process Validation Lifecycle: 10 Years in Review
    Moderator: CDR Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, CDER, U.S. FDA

    SUPPLY CHAIN & MANUFACTURING CHALLENGES

    B4: ICH Update: Q9, Q12, and Other Initiatives
    Moderator: Clarice H. Hutchens, PhD, MA, DM, Senior Director, Pfizer

    EMERGING TRENDS & INNOVATION

    C4: Moving Quality to the Next Level: "What Would it Take?"
    Moderator: Mike G. Labruto, MS, Executive Director, GlaxoSmithKline

    13:15 – 13:45 | Virtual Exhibit Hall and Connect & Network

    13:45 – 15:15 | Concurrent Sessions

    QUALITY ASSURANCE & QMS

    A5: Managing Investigations in a Global Network
    Moderator: Rick L. Friedman, MS, Deputy Director, OMQ CDER, U.S. FDA

    SUPPLY CHAIN & MANUFACTURING CHALLENGES

    B5: Sterile Drug Hot Topics
    Moderator: Douglas A. Campbell, Senior Consultant, InterPro QRA

    EMERGING TRENDS & INNOVATION

    C5: All That Data…Now What?
    Moderator: Sharyl D. Hartsock, Senior Director Quality, Global Quality Systems, Eli Lilly and Company

    15:15 – 15:45 | Break

    15:45 – 17:15 | Plenary 6: Closing Plenary
    Moderator: Mary E. Farbman, PhD, Executive Director, Global Quality Compliance, Merck & Co., Inc.

Learning Objectives

At the completion of this conference, participants will gain skills to:

  • Conduct successful investigations of Out-of-Specification (OOS)/Out-of-Trend (OOT) findings
  • Effectively implement data integrity remediation
  • Establish robust processes and maintain state of controls
  • Improve product availability and avoid shortages
  • Manage post-approval changes and change management processes
  • Successfully implement quality management techniques and robust manufacturing
  • Update facilities to support dependable quality and supply

Who Should Attend

Departments
  • Corporate Offices, Research and Development
  • Regulatory Affairs
  • Manufacturing
  • Quality Assurance/Control
  • Marketing
  • Sales
Job Function
  • Quality Assurance
  • Manufacturing
  • Compliance/Inspection Management
  • Supply Chain
  • Auditing
  • Executive Management
Academia
  • Pharmaceutical sciences
  • Regulatory science
Global Regulatory Authorities

Registration Fees

Register Now
Early Registration
Registration Type Price by 31 July 2021
Member $958
Non-member $1098
Govern./Health Authority/Academic Member $280
Govern./Health Authority/Academic Non-member $320
Student Member $112
Student Non-member $124
Young Professional Member $479
Regular Registration
Registration Type Regular Registration
Price after 31 August 2021
Member $1,341 $1,724
Non-member $1,537 $1,976
Govern./Health Authority/Academic Member $392 $504
Govern./Health Authority/Academic Non-member $448 $576
Student Member $157 $202
Student Non-member $174 $223
Young Professional Member $671 $862

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  • Molly E. O’Neill, CMP
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    Tel: +1 (301) 656-5900 ext. 132
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