11th Qualified Person Forum & ½ Day Pre-Conference Session: The new Annex 16: Quality Risk Management for QPs

30 Nov - 2 Dec 2016, Madrid, Spain

Course No. 15365



Speakers from Authorities and Public Health Organisations:

Klaus Eichmüller, Wolnzach, c/o German GMP Inspectorate
Dr Rainer Gnibl, Government of Upper Franconia
Paul Hargreaves, MHRA and PIC/S Chairman
Mag.pharm. Andreas Kraßnigg, Austrian Agency for Health and Food Safety (AGES)
Gillian Renouf, Royal Pharmaceutical Society QP Assessment Panel

Speakers from the Industry:
Justin Barry, Midatech Pharma España
Richard M. Bonner, Chairman of the EQPA, form. with Eli Lilly
Dr Susanne Ding, Boehringer Ingelheim
DI Georg Göstl, Baxter AG
Tor Gråberg, AstraZeneca
Dr Afshin Hosseiny, Tabriz Consulting
Dr Ulrich Kissel, Roche Pharma
Dr Line Lundsberg-Nielsen
NNE Pharmaplan, Aidan Madden
FivePharma, Dr Jean Denis Mallet
Form Head of the French Pharmaceutical Inspection Department
Sue Mann, Sue Mann Consultancy
Ann McGee, McGee Pharma International
form. Irish Health Products Regulatory Authority
Dr Bernd Renger, Immediate Past Chairman of the EQPA
Markus Roemer, comes compliance services
Niina Taylor, Pfizer
Andrew Teasdale, AstraZeneca
Brenda Van Assche, Janssen Pharmaceutica NV
Philippe Van der Hofstadt, B&C Group


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.


Dear Colleagues,

In the last ten 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 11th 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.


1/2 Day Pre-Conference Session on 30 November

The new Annex 16: Quality Risk Management for QPs
Facilitated by:
Richard M. Bonner / Aidan Madden

The term “quality risk management” is used throughout the new Annex 16. But how could the QP use this tool? In this session you will get some practical advice!

Programme QP Forum

What the QP needs to know about the new Annex 15
The influence on the work and responsibility of the QP
Expectation of an inspector
Klaus Eichmüller

What the QP needs to know about Serialisation
Implementation of the FMD: influence on batch documentation and certification
Challenges for industry and especially the QP
Jean-Denis Mallet

The Detection of falsified Medicines
The protection of the public and how the QP could support this
Paul Hargreaves

What the QP should know about Out of Stock Situations
Co-operation with the authorities
Tor Gråberg

Case Study on the QP Declaration
Challenges and possible solutions
Experiences made
Ulrich Kissel

Elemental Impurities: global Approaches and possible Solutions
What are the global challenges (different expectations, different directions?)
What is the role and responsibility of the QP?
Case study
Andrew Teasdale

1) Update on GMP-relevant Topics and what QPs are expected
to do
Discussion, questions, answers
Bernd Renger and Rainer Gnibl

2) The QP and ICH Q8/ Q12
The link to PAT and Real Time Release
Batch documentation and batch certification: things to consider
for QPs
Line Lundsberg-Nielsen and Afshin Hosseiny

3) QP Scenarios – How serious could they be?
Make decisions based on real-life situations
Sue Mann and Gillian Renouf

4) Quality Oversight of IMP QPs in global Supply Chains
Maintaining quality oversight at relevant interfaces
Testing of IMPs in various scenarios (importation, intercompany-, intracompany shipments)
QP GMP declaration for 3rd country IMP manufacture
IMP Working Group

5) Data Integrity: Why it is so important for QPs
How can the QP be sure about the integrity of data: what to focus on, what to check
Markus Roemer and N.N. (speaker invited)

6) Quality Metrics vs. Quality Parameters
What are the different expectations in the EU and the US
What is important for QPs
How to interpret data
How the QP can use quality data reviews for their daily work
Ann McGee and N.N. (speaker invited)

You will be able to attend three of these parallel sessions. Please choose the ones you like to attend when you register for the Forum.

This training/webinar cannot be booked. Send us your inquiry by using the following contact form.

To find alternative dates for this training/webinar or similar events please see the complete list of all events.

For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.

* also payable by credit card
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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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