PDA Global Sterile Manufacturing Regulatory Guidance Comparison Workshop 2024

A One-Stop-Shop for Global Aseptic Processing Expectations

Washington, DC
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Calling on all professionals and teams who are involved with the manufacture of aseptically filled sterile drug products for markets around the world.

Attending PDA’s new Global Sterile Manufacturing Regulatory Guidance Comparison Workshop is critical for navigating an extremely complex regulatory environment.

The workshop, based on PDA’s Global Sterile Manufacturing Regulatory Guidance Comparison Book (newly revised for release in fall 2024) and its updated comparison toolset, brings forward the regulations and information you need to ensure the compliance of your aseptic filling operations with Good Manufacturing Practice (GMP) for all major market countries and regions.

Even if you were one of the 5,000 individuals who purchased and used PDA’s Global Sterile Manufacturing Regulatory Guidance Comparison Book published in 2016, you know expectations around the world continue to change. Keeping pace with the global regulatory requirements can be overwhelming for anyone. This update fills a much-needed gap in simplifying the challenging task of looking across regulatory guidances to ensure global compliance.

It is a professional imperative that you attend the workshop.

Why Attend?

The necessity to meet the requirements for where products are manufactured as well as where they are sold can confound the most experienced professionals and teams.

Keeping track of so many variations and ensuring compliance of manufacturing activities is an absolute must for international pharmaceutical manufacturing professionals and the companies they represent.

The newly-revised PDA Global Sterile Manufacturing Regulatory Guidance Comparison Book (2024), and associated comparison toolset presents similarities and differences in guidelines for aseptic processing from seven GMP guidances: U.S. FDA, European Commission, the World Health Organization (WHO), Pharmaceutical Inspection Co-operation Scheme (PIC/S), Canada, China, and Japan.

You receive not only immersion in the updated book content but will immediately learn how to use the comparison tool set (used by pharma manufacturing professionals around the world) to help identify gaps that may exist in your current operations and hear directly from the industry experts who literally wrote the book.

What You Gain
  • You receive an early release copy of the book* and all of its tools and supporting documents (at no additional charge). This is a valuable resource to have in your hands to facilitate alignment across regions before the book is released to the industry!
  • A two-day engaging, educational and practical workshop with hands-on experiences filled with practical real-world advice to ensure understanding and appropriate manufacturing compliance.
  • Immediate application of new knowledge and understanding via facilitated and group-led discussions, case studies, and role-playing exercises.
  • Industry expert presentations on Good Manufacturing Practice (GMP) specific to aseptic processing in these best practice areas:
    1. How to perform a gap assessment in global aseptic processing requirements.
    2. How to master internal assessment of sterile manufacturing.
    3. How to inform decision-making when considering future investments.
    4. How to apply PDA’s comparison tool to ensure your training programs are in alignment with Health Authorities’ expectations and industry best practices.
    5. How to consider the impact of quality management systems on business operations.
    6. How to identify and discuss significant misalignments of the seven major sterile manufacturing guidances.

Attend the workshop to learn from PDA’s industry experts and your peers and become informed and empowered about sterile manufacturing regulations and compliance from U.S. FDA, European Commission, the World Health Organization (WHO), Pharmaceutical Inspection Co-operation Scheme (PIC/S), Canada, China, and Japan.

*PDA will release the revised Global Sterile Manufacturing Regulatory Guidance Comparison book to the industry and public for purchase in October 2024.

PROGRAM PLANNING COMMITTEE

  • Joseph Frantz, Retired (Chair)
  • Brian Bell, Amgen Inc.
  • Amanda Curtis, ValSource, Inc.
  • Nidhi Shah, Bristol Myers Squibb
  • Christine Sherman, Takeda

Early Registration

Register by 26 July 2024

Member Price

$1,595

GovernmentMember Only

$895

Health AuthorityMember Only

$895

Early Career ProfessionalMember Only

$1,395

StudentMember Only

$595

AcademicMember Only

$895

Non-Member

$1,995

Standard Registration

Register after 26 July 2024

Member Price

$2,095

GovernmentMember Only

$995

Health AuthorityMember Only

$995

Early Career ProfessionalMember Only

$1,495

StudentMember Only

$695

AcademicMember Only

$995

Non-Member

$2,395

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].

Wednesday, 11 September EDT

  • Registration Open

  • P1: How to Compare Global Sterile Manufacturing Regulations

    • Moderator: Joseph C. Frantz, MS, PhD, Consultant

    Join us for an immersive session demonstrating how to leverage PDA’s Global Sterile Manufacturing Regulatory Guidance Comparison (2024). Learn practical strategies and approaches for leveraging PDA’s comparison tool in achieving regulatory compliance and the potential competitive edge of understanding and addressing regulatory challenges. The expert presenters will reveal the mindset of regulators and share insights into their priorities and concerns, including the limited focus on the global market and the emphasis on local laws and regulations.
    • Welcome and Opening Remarks from Workshop Chair

      • Chair: Joseph C. Frantz, MS, PhD, Consultant

    • Seeing the Challenge and Charting the Course

      • Presenter: Josh Eaton, MS, Senior Director, Scientific and Regulatory Affairs, PDA

    • Navigating Regulatory Minds: Strategies and Practices for Compliance

      • Presenter: Stephen E. Langille, PhD, Senior Microbiology Consultant, ValSource, Inc.

    • Q&A

  • Networking Reception in the Exhibit Area

Thursday, 12 September EDT

  • Continental Breakfast

  • Registration Open

  • P2: Using the Comparison to (Re-)Design a Training Program

    • Moderator: Christine Sherman, Global Sterility Assurance & Microbiology, Takeda

    A robust training program is critical to ensuring manufacturing staff compliance, however, the design and maintenance of training programs tend to be an afterthought. Gaps in the training of both new and experienced staff include missing references to applicable guidelines, no explanation as to the “why” behind the instruction, and insufficient or lack of training for certain tasks are common. Get an introduction on how to use the comparison document to ensure your training programs are in alignment with Health Authorities and general best practices. Case studies and small group working sessions will illustrate some commonly found gaps in training programs and offer practical experience using the comparison document to identify and remediate them.
    • Building a Solid Foundation by Optimizing Your Training Program

      • Presenter: Amanda Curtis, Microbiology Consultant, ValSource, Inc.

    • Designing a Compliant Aseptic Process Simulation (APS): Small Group Work

      • Presenter: Amanda Curtis, Microbiology Consultant, ValSource, Inc.

    • Report Out and Discussion

  • Networking Break in the Exhibit Area

  • P3: Significant Misalignment of Sterile Manufacturing Guidances

    • Moderator: Amanda Curtis, Microbiology Consultant, ValSource, Inc.

    The Global Sterile Manufacturing Regulatory Guidance Comparison analyzes seven international sterile manufacturing guidances. Although many requirements and expectations are aligned across these documents, there are differences that exist. In some cases, these differences are vernacular or theoretical, while others are significant. And to make it more challenging, some health authorities require additional measures that are not a part of other sterile manufacturing guidelines. In this session, we will identify and discuss significant misalignments of the seven sterile manufacturing guidances. We also provide an opportunity for industry peers to discuss mitigation strategies and communication approaches for regulatory documents and inspections.
    • Understanding the Differences of Sterile Manufacturing Guidance for Personnel, Training, and Qualification

      • Presenter: Nidhi Shah, MBA, Senior Director, Value Stream CAR-T Manufacturing Operations, Bristol Myers Squibb

    • Manufacturing Facilities and Equipment: The Old, the New, and the Challenging

      • Presenter: Brian L. Bell, PhD, Senior Director Cellular Sciences, Amgen Inc.

    • Hands-On Exercise Addressing Challenges in Implementing International Sterile Guidance

      • Presenter: Brian L. Bell, PhD, Senior Director Cellular Sciences, Amgen Inc.

      • Presenter: Nidhi Shah, MBA, Senior Director, Value Stream CAR-T Manufacturing Operations, Bristol Myers Squibb

    • Report Out and Discussion

  • Networking Lunch in the Exhibit Area

  • P4: Effective Strategies for Comprehensive Gap Assessments

    • Moderator: Brian L. Bell, PhD, Senior Director Cellular Sciences, Amgen Inc.

    Do you dread the task of completing a gap assessment against a regulatory document or internal Standard Operating Procedure? You’re not alone! Many of us have faced the overwhelming challenge of this assignment. Join this session to learn how to conduct a comprehensive gap assessment for your facilities without feeling like you’d rather be at the dentist. Through hands-on exercises, we’ll explore the essential components of effective gap assessments and what they should not entail.
    • Congratulations! You Have Volunteered to Complete a Gap Assessment

      • Presenter: Christine Sherman, Global Sterility Assurance & Microbiology, Takeda

    • Finding the Gaps: Hands-On Strategies

      • Presenter: Christine Sherman, Global Sterility Assurance & Microbiology, Takeda

    • Report Out and Discussion

  • Networking Break in the Exhibit Area

  • P5: The Impact of Quality Management Systems on Business Operations

    • Moderator: Nidhi Shah, MBA, Senior Director, Value Stream CAR-T Manufacturing Operations, Bristol Myers Squibb

    A comprehensive quality management system holds significant potential to harmonize business operations with regulatory requirements, leading to efficient solutions that enhance overall quality in a cost-effective manner. In this session, a case study will serve as a practical example showcasing an effective approach. Engage in role-playing exercises that simulate the process of presenting these strategies to senior management for approval. Don’t miss the opportunity to gain actionable insights to apply in your own professional settings!
    • Creating a Simplified Value Stream Map: Small Group Work

      • Presenter: Joseph C. Frantz, MS, PhD, Consultant

    • Group Discussion: How to Have Effective Communication with Senior Management

    • Closing Remarks from Workshop Chair

      • Chair: Joseph C. Frantz, MS, PhD, Consultant

Agenda is subject to change.

Presenters

  • Brian L. Bell, PhD

    Senior Director Cellular Sciences, Amgen Inc.

    Committee Member
    Moderator
    Presenter
    Read Bio
  • Amanda Curtis

    Microbiology Consultant, ValSource, Inc.

    Committee Member
    Moderator
    Presenter
    Read Bio
  • Josh Eaton, MS

    Senior Director, Scientific and Regulatory Affairs, PDA

    Presenter
    Read Bio
  • Joseph C. Frantz, MS, PhD

    Consultant

    Chair
    Moderator
    Presenter
    Read Bio
  • Stephen E. Langille, PhD

    Senior Microbiology Consultant, ValSource, Inc.

    Presenter
    Read Bio
  • Nidhi Shah, MBA

    Senior Director, Value Stream CAR-T Manufacturing Operations, Bristol Myers Squibb

    Committee Member
    Moderator
    Presenter
    Read Bio
  • Christine Sherman

    Global Sterility Assurance & Microbiology, Takeda

    Committee Member
    Moderator
    Presenter
    Read Bio

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.

Individual reservations cancelled within seventy-two (72) hours prior to arrival will forfeit one night’s room deposit. Individuals will be responsible for payment of their own cancellation fees.

Discover the vibrant heart of the city at the new Westin Washington, DC Downtown—an energizing gathering place bursting with fresh ideas. Immerse yourself in the allure of iconic experiences, just steps away from the hotel in Washington, DC. From the National Mall to Chinatown, Capital One Arena to CityCenterDC, the best of the city awaits outside the doors. Unwind in the 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 complete transformation has given rise to inspiring spaces, where Westin guests thrive, finding productivity and rejuvenation in perfect harmony.

Additional Hotel Information

  • 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).