PDA Global Sterile Manufacturing Regulatory Guidance Comparison Workshop 2024

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.