10th Qualified Person Forum: 1/2 Day Session "Appropriate Quality of Excipients"

24 November 2015, Berlin, Germany

Course No. 9335

header-image

Programme

1/2 Day Pre-Conference Session Appropriate Quality of Excipients
Facilitated by:
Richard Bonner / Tony Scott / Edit Szõcs
QP survey on excipients: outcome and interpretation of the data
What level of GMP and supplier qualification is needed (and what is too much)
Challenges and solutions


QP Forum, 25 - 26 November 2015

Keynote: The QP Job - what about Ethics and Culture?
Comply or die?
Responsibility, confidence & dialogue: My triangle of orientation
Wolfgang Loh

The Falsified Medicines Directive: Harmonisation needed?
The Written Confirmation and the impact on global pharma
Differences of the transposition of the FMD into national law
Different countries - different approaches
The FMD: a more secure supply chain now?
Liz Tolan

The Falsified Medicines Directive: What will be important?
New packaging design and Change Control
Batch Record Review and batch release
How to handle returns (are all returns falsified medicines?)
What to do in the case of suspected falsification
Tor Gråberg

Data Integrity: what the QP needs to know
Why is it making everybody nervous?
Data Integrity in the own company
Data Integrity with suppliers and contractors
Dr Bob McDowell

PAT and Real Time Release: really a hot Topic for QPs?
What is the current status? (is anyone doing that at all?)
Things to consider for QPs
The link to process validation and master batch documentation
Dr Line Lundsberg-Nielsen

Cross Contamination Observations: what a QP can learn
Poor practices observed
Examples of deficiencies & recommendations
Recalls related to cross contamination
Risk Management

Why QPs should love Statistics (a final Presentation)
The power of statistical techniques and error theory
Statistical interpretation of data
What is necessary for QPs
Christopher Burgess


Parallel Sessions: Working on Case Studies

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

2) Annex 16 - Status quo and new tasks
Delegation
QP Discretion
Ulrich Kissel and Christina Meissner

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

4) The Role of the QP at the GMP/GCP interface
Where does the IMP QP responsibility end?
Where and when should the IMP QP be involved in the clinical trial (e.g. Site-to-site transfer, temperature excursions, shelf life extension, complaint handling, joint GMP/GCP inspections etc.)
Managing incidents at the GMP/GCP interface
IMP Working Group

5) The QP/GDP Interface
Where does responsibility end and when does it come back?
QP and RP co-operation
Deviations in the supply chain: reporting and handling
Johanna Linnolahti and Aidan Madden

6) The QP and Contracts
What does a QP need to know?
EU regulations vs. non-EU regulations - what counts?
How to keep the overview
Involvement of the QP
Afshin Hosseiny and Monika Hupfauf

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.

Q&A Session
During the 2 days of the Forum, delegates can post their questions. The answers will be given by the expert speakers in a dedicated session and/or published in the members' area of the EQPA web-site.

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
American Express Visa Mastercard

icon
Further dates on-site
Further dates on-site
Not available
icon
Further dates online
Further dates online
Not available
icon
Recording
Not available

Do you have any questions?

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

Woman with headset

Go back

Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023