Skip To The Main Content

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
  • Chapter
  • Online


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.


  • 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.

Got a Question? We have answers

Contact Us
Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information


Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Media Partners

PDA Members Save Substantially