Wissenschaft, Forschung, Bildung
29.02.2016 - 02.03.2016
Experiences with the New FDA and EU Guidelines on Process Validation
29th February and 1st March 2016 - Conference
2nd March 2016 - Workshop
The FDA and EU published a lot of guidelines regarding process validation which makes it hard to keep up with all the changes. As a result a lot of questions and uncertainties arise: How can CPV be implemented into daily business? How can companies assure the detection of unplanned deviations in the most economic way? Where are EU’s Guidance, ICH Q8 and CPV blending and how can they be merged and implemented most reasonably? Where does Statistical Process Control (SPC) fit into the CPV plan?
The international conference Continued and On-Going Process Verification in Berlin will, answer all the pressing questions and provide networking opportunities.
Network with the Leading Companies in Pharma and Biotech on Topics Like
* EU Regulatory Expectations since Entry of the Revised EU GMP Annex 15
* FDA’s Culture of Quality and Quality Metrics on Process Validation
* Quality by Design: CPV in Practice
* APR/PQR in Re-Validation and Technology Transfer
* Risk Based Approaches to CPV
The workshop on QbD and Continued Process Verification covers: the regulatory landscape, building process knowledge – fact and risk based process design, reaction mechanisms and criticality of organisational structures, the evolution of a CPV programme and opportunities for continuous improvement.
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