12th QP Forum & 1/2 Day Pre-Conference Session The QP in special Areas

12th QP Forum & 1/2 Day Pre-Conference Session The QP in special Areas

Budapest, Hungary

Course No 15768


Costs

Non-QPA Members: EUR 2180,--
EU GMP Inspectorates: EUR 1285,--
QP Association Members: EUR 1980,--

(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



Programme

29 November 2017
1/2 Day Pre-Conference Session The QP in special Areas: ATMPs, Radiopharmaceuticals, Blood and Blood Products
New classes of medicines such as ATMPs, Blood and Tissue Products or
Radiopharmaceuticals are creating special challenges for the QPs
certifying these products. This session aims to provide good insight and
experienced views, address and discuss challenges and see what the
participating delegates can learn from each other.

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
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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