Webinar - Proposed Revision to EU GMP Annex 16 on Qualified Persons

About this course

The draft revision of Annex 16 is a complete re-writing of this crucial guidance that addresses the fundamentals of how medicinal (drug) products are released for sale within the EU/EEA. This draft seeks to address the challenges posed by the continuing globalisation of pharmaceutical manufacturing and improve harmonisation across Europe.

In this webinar Peter Gough, NSF Health Sciences expert on pharmaceutical law and the role of the Qualified Person (QP), will review the proposed revision and look at the changes that this could make to areas such as:

• The responsibilities of MA holder and the QP
• The linkage between QP certification and batch release
• The process of QP certification
• The sampling and testing of imported products
• The use of third party audits
• Unplanned deviations and the so called ‘QP discretion’

Comments on the proposed changes are due by 7 November, so don’t miss this opportunity to fully understand the implications of this extensive change.

Course outline

• The responsibilities of MA holder and the QP
• The linkage between QP certification and batch release
• The process of QP certification
• The sampling and testing of imported products
• The use of third party audits
• Unplanned deviations and the so called ‘QP discretion’

The webinar will start at 4.00pm BST and will be approximately 1 hour long

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

What you've said

These are just a couple of examples of the type of feedback we get from our course delegates

“Superb, enjoyable and expertly delivered.”

Doug Strachan, Emcor, UK

“The standard of lecturers/presenters was excellent, very impressed with the quality and completeness of the material covered.”

Gerrard Kemmy, Covidien, Republic of Ireland