12th QP Forum & Full Day Pre-Conference Session: Investigational Medicinal Products

12th QP Forum & Full Day Pre-Conference Session:  Investigational Medicinal Products

Budapest, Hungary

Course No 15765


Non-QPA Members: EUR 2480,--
EU GMP Inspectorates: EUR 1585,--
QP Association Members: EUR 2280,--

(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



29 November 2017
Full Day Pre-Conference Session
Specifi c Requirements for IMPs
New legislation impacting IMP QPs
Just-in-time labelling/ on demand packaging and labelling
Interactive sessions and case studies – decision making of IMP QPs
ATMP Task Force (IMP focus): introduction and current status

Programme QP Forum
30 November – 1 December 2017
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 – Eric J.M. Meier
Batch defi nition 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 – David Cockburn
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
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

Update: International Harmonisation and Working

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