ISPE Nordic Conference

Annex 15 Updates
Qualification & Validation
and
Continuous Process Verification

May 26 2016 in Stockholm, Sweden

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In October 2015 the revised EU GMP Annex 15 regarding Qualification and Validation was released.

This ISPE seminar will highlight the changes from a regulatory perspective. The seminar will also present Continuous Process Verification (CPV) and how this is approached by our industry. The conference is one of few opportunities in the area to objectively learn more about a new mandatory regulation that all in pharmaceutical industry must adopt to.

Programme:
08:00 – Registration open
08:30 – Conference start and welcome by Anna Kävlemark
08:45 – General updates of Annex 15 and CPV by Inger Jönebring
09:45 – Seamless intergration of ASTM E2500 and Annex 15 by Daniel Nilsson
11:00 – The real Challenge of Annex 15 by Dr. Lorenz Liesum
12:30 – The bridge between traditional validation and CPV approach by Timur Güvercinci
13:30 – Design of Risk Based efficient approach to CPV by Tara Scherder
14:45 – Implementing CPV in small organisation by Monica Hueg and Vibeke Jensen

Download the conference programme ( 3 MB).

During the conference, you will be given the opportunity to see and learn from others who have implemented the new requirements in a production environment.

It will also be possible to buy the ISPE PQLI® Guide: Part 4 – Process Performance and Product Quality Monitoring System as part of this conference.

Further informations – please contact
Anna Kävlemark, e-mail: anna.kalvemark@complyit.se
  

Photo of Anna Kavlemark