EU GMP Changes

About this course

Time: 10am EST - Duration: 1 hr

Proposed and recently implemented changes to the EU GMPs (EudraLex Volume 4 Part 1) are reviewed in detail; changes to Chapters 1 to 9 and the Annexes will be covered. This webinar will cover what the EU is expecting to minimize cross contamination risks in production, effectively transfer analytical methods, significant changes in the area of process validation, and the expanding role of the Qualified Person. We will help you understand the changes, their rationale, and what you need to do to be well prepared.

What You Will Learn

• EudraLex Volume 4 Part 1, Chapters and Annexes, are reviewed for changes made effective in 2013
• Proposed changes to EudraLex Volume 4 Part 1, Chapters and Annexes, and their potential impact
• Understand how to best interpret these changes and what actions to take

Course outline

• EudraLex Volume 4 Part 1, Chapters and Annexes, are reviewed for changes made effective in 2013
• Proposed changes to EudraLex Volume 4 Part 1, Chapters and Annexes, and their potential impact
• Understand how to best interpret these changes and what actions to take

Venue

Webinar

Please register through the ‘book now’ button on the right to receive joining instructions

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our expert for this webinar is:

• 

  Mr Peter Gough
  Executive Director
  MSc, CSci, CChem, FRSC, FCQI, CQP

  • [email protected]
  • +44(0)1751 432999
• 

  Mrs Janeen Skutnik
  Vice President
  BSc

  • [email protected]
  • + 1 857 277 0060

What you've said

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