12th Qualified Person Forum

12th Qualified Person Forum

Budapest, Hungary

Course No 15771


Costs

Non-QPA Members: EUR 1790,--
EU GMP Inspectorates: EUR 895,--
QPA Members: EUR 1590,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Objectives

This Conference is designed by QPs for QPs as an international Expert Forum with focus on sharing information and experience and on discussing the critical areas of the QP’s daily work.

Background

Dear Colleagues,
In the last eleven years, the European QP Association Forum has been becoming a
major event for European Qualified Persons.
Speakers from EMA, FDA and various national authorities as well as QPs have been sharing their view of roles and responsibilities of the Qualified Person.
Hoping to continue the success of this unique Forum, the Advisory Board of the QP Association has set up the programme at hand for the 12th QP Forum to give you an update about recent developments and important matters to consider. Representatives from the authorities as well as QPs and well-known experts will present latest issues and share their point of view. During the three pre-conference sessions and the six parallel sessions at the Forum, various case studies will be presented and discussed to come up
with possible solutions.
Make use of this event by exchanging experiences with your colleagues and by establishing informal contact and networking.

I would like to invite you to this outstanding event, and I look forward to meeting you.
Best regards,
Richard M. Bonner
Chairman of the Qualified Person Association

Target Group

The Forum is designed for all Qualified Persons and aspiring Qualified Persons. It also addresses upper management functions and authority representatives who want to be informed about the latest development regarding the duties and responsibilities of
Qualified Persons.

Programme

The X-Factor

  • Human behaviours and errors & what the QP needs to know about these
What the QP needs to know about Continuous Manufacturing and Real Time Release
  • Batch definition in continuous manufacturing
  • Important GMP and Quality aspects to consider
  • Control Strategy using PAT and automation
  • State-of-control operation
  • Batch Release
Falsifications: Handling, Decision Making and Communication
  • A case study on the amount of activities and involvement of the QP
International Developments and their possible Impact on GMP and
Manufacturers

  • Brexit
  • MRA with FDA and other MRAs
  • The role of WHO in regulating GMP
  • What is on the horizon in the GMP area
What the QP needs to know about the current Cleaning Validation Requirements
  • What is new?
  • Minimising the risk of cross contamination
  • Change control and information fl ow
  • Involvement of the QP
The Involvement of the QP in Auditing
  • What is necessary
  • How to instruct a 3rd party (or own company) auditor
  • How to interpret 3rd party audit reports
  • What to do with a negative audit outcome (QP Declaration and supplier approval)
Update: International Harmonisation and Working

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