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28 February 2008

Review of the QP Education Course in Vienna, 21–22 February 2008

On 21 and 22 February more than 50 QPs, future QPs and delegates who are interested in the duties and responsibilities of a QP met in Vienna to hear about and discuss general compulsory and regulatory issues. The Education Course was compiled by the QP Association Advisory Board to provide a general idea of the special tasks and responsibilities of a Qualified Person. In various workshops, case studies were presented to discuss and convey possible solutions to given problems.

In his opening presentation, Dr Chris Burgess, QP in the U.K. gave an overview about the legal and professional duties of the Qualified Person. In descriptive flow charts, the legal background and additional duties were presented in a comprehensive manner. Guidance was also given with respect to essential knowledge and practical experience the QP needs to have.

Lance Smallshaw of Eli Lilly presented a complete overview about the recent changes in EU legislation. An outlook was given towards growing GMP-requirements for excipients and the envisaged revisions to EU GMP Guidelines.

Richard Bonner explained and elaborated the role of the QP in assuring product quality. It was discussed when and how the QP needs to be involved in the various steps of the manufacturing process. Questions like:

  • Does the QP need to release the API?

  • Does the QP need to perform all audits?

  • How can the QP assure supplier qualification?

  • Who needs to sign the contract?

were addressed. Also, EMEA’s Statement on QP Discretion on Batch Certification was part of this comprehensive presentation.

In a workshop moderated by Dr Bernd Renger, Chairman of the QP Association, six real case studies were presented. In small groups the QPs talked about appropriate actions and release decisions and outlined possible strategies in case of an inspection.

In Richard Bonner’s workshop on Batch Disposition, the groups discussed the disposition of a formulated parenteral batch of a live-saving oncolytic product. Based on the information given, the QPs had to decide what actions to take.

This first day of the QP Education Course was completed by a very special social event. Vienna is not only famous for its romantic nostalgia & modern hype, but also for one of the best movies ever made. The film noir masterpiece "The Third Man", broaches the issue of fake drugs in post-war Vienna. Dealers of counterfeited or diluted medicines are no less unconscionable today than they were decades ago, but meanwhile the business has grown to a frightening degree. The participants got a picture of this story during this special event.

Day 2 of the course started with a third workshop. Questions were elaborated and answered what a QP needs to know about laboratory operations to ensure correct decision making. This interactive session was presented by Dr Chris Burgess and Lance Smallshaw. Questions addressed were for example:

  • What should the QPs do to assure themselves that the laboratory is in compliance?

  • How to assure that the laboratory CAPA system is efficient and effective

John Taylor, Quality and Standards Manager of the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) presented the possibilities of delegating duties and responsibilities. The role of contract QPs was also part of this talk – an issue which is getting more and more into discussion; especially when the QP’s availability at the manufacturing site is questioned.

Dr Renger’s presentation then further elaborated the role of the QP in supplier qualification. Topics were regulatory and authority expectations, audits, assessments, risk based qualification and joint audits to name a few.

Another area, where the QP is getting more and more involved, is the pharmaceutical supply chain. Storage and transportation compliance issues and concerns were presented by John Taylor and possibilities how to face these challenges were discussed.

How to face regulatory inspections and current inspection hot topics were then introduced by Richard Bonner in the last session of this QP Education Course.

This successful event will be repeated in Berlin, Germany, on 1-2 October 2008.

Wolfgang Schmitt
On behalf of the European QP Association

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