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PDA New England Chapter Webinar: A new sterility assurance paradigm? A deep dive into the EU GMP Annex 1 revision

Sep 02, 2020
1:00 PM
-
2:30 PM
| Eastern Standard Time
Online
  • Chapter
  • Online
Register Now

Overview

EU GMP Annex 1 is undergoing a substantial revision. The Annex sets out the minimum standards for the manufacture of sterile products (both aseptically filled and terminally sterilized). A major focus within the Annex is on the need for a contamination control strategy and with applying the principles of quality risk management (QRM).

This webinar examines the main changes contained within the revision and what this signals for bio-pharmaceutical manufacturers. This includes the role of barrier technology to protect products, to novel technologies for assessing the manufacturing process.

Speaker Information

Dr.Tim Sandle works for a sterile products manufacturer in the UK. He is also a visiting lecturer at the University of Manchester (teaching pharmaceutical microbiology) and University College London (training Qualified Persons). Dr. Sandle has written or edited 30 books and 165 peer reviewed papers, plus 500 technical papers relating to microbiology and pharmaceuticals.

Agenda

  • Key Discussion Topic:

    • Contamination Control Strategies applying Quality Risk Management

Who Should Attend

  • Quality Control
  • Quality Assurance
  • Quality Systems
  • Regulatory / Compliance
  • Clean-room Management
  • Manufacturing
  • Validation

Registration Fees

Register Now
Registration Type Price
Member* $25.00
Non-Member $65.00

*A special discount is available for PDA Members. To get this discount code, send an email to PDA Membership Dept: [email protected] or Shanna Morgan, [email protected].

NOTE: When entering a discount code, ensure that all characters are in UPPER case, when applying. Do not cut & paste.

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