Experiences with the New FDA and EU Guidlines on Process Validation
29th February and 1st March 2016 – Conference
2nd March 2016 – Workshop
The FDA and EU published a lot of guidlines regarding process validation which makes it hard to keep up with all the changes. As a result a lot of questions and uncertanties 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 is created to show best practice cases, answer all the pressing questions and provide networking opportunities.
Bernd Bödecker (GMP Inspectorate of Hannover, Germany) talks about on-going process verification – EU regulatory expectations since the entry of the revised EU GMP Annex 15 into force. Aidan Collins (Eli Lilly Company, Ireland) covers a risk based approach to CPV. The topic María Jesus Alonso (Reig Jofre Group, Spain) is presenting will be APR/PQR in re-validation and technology transfer – implementing CPV into business. A business case for Stage 3: Continued/on-going process verification will be introduced by Ajay Pazhayattil (Apotex Inc., Canada).
Ajaz S. Hussain (Insight, Advice & Solutions, LLC (Former FDA Deputy Director), USA) provides an insight into FDA”s trending new validation strategies.
The workshop on the 2nd March covers QbD and Continued Process Verification, including exploring the regulatory landscape, building process knowledge – fact and risk based process design, reaction mechanisms and criticality of organisational structures in addition to the evolution of a CPV programme and opportunities for continuous improvement.
For more information please visit:
Sabine Groß, Marketing Manager
Tel. +41 71 677 8700, Fax +41 71 677 8701
Die Chem-Academy veranstaltet erstklassige Tagungen, Konferenzen und Workshops zu aktuellen Themen aus der chemischen Industrie. Die Veranstaltungen zeichnen sich durch einen hohen Praxisbezug und erfahrene Referenten aus Wissenschaft und Praxis aus.