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Event info
Date:16 May
Time:08:30 - 11:00
Venue:Medicon Valley Alliance (HubNordic) – Auditorium, Arne Jacobsens Allé 13, 2300 Kbh. S (Ørestad)
Contact person
Mia Ritterband-Rosenbaum

Mia Ritterband-Rosenbaum

Event Manager & PA to CEO

+45 21 63 38 88

Ensuring alignment with FDA/EMA guidelines through Continuous Process Verification (CPV)

Continued Process Verification (CPV) is replacing the traditional three PQ batch approach in the pharmaceutical industry. The FDA issued Warning Letters to seven companies in fiscal year 2021 for process validation issues, citing 21 CFR 211.100 (Subpart F- Production and Process Controls, written procedures; deviations). If you are currently in stage 3 and have not implemented CPV, you may not be in compliance with current standards and could face audit challenges.

Join us for an informative event on how to stay up-to-date with current standards and solve process validation challenges in the pharmaceutical industry.

Don’t miss this opportunity to stay ahead of the game and ensure the success of your current and future operations!

Key learning objectives:

  • Discover the latest updates on the shift from ISPE’s 3-batch method to Continued Process Verification (CPV)
  • Gain an understanding of the challenges associated with implementing a CPV strategy from stage 3
  • Explore practical approaches for successfully implementing CPV in your specific context

Date: Tuesday, 16th of May, 2023
Time: 8:30 – 11:00 CET
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Meeting room: Auditorium



08:30 Networking, registration and light breakfast
09:00 Welcome
David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance
Michael Schmidt, Marketing Specialist at JMP
09:05 What is new in ISPE 3-batch-method and CPV?
Christian Bille, Systems Engineer, JMP
09:45 Practical applications of how CPV can be implemented
Per Vase, Managing Partner, NNE
Louis Meyer, IT Consultant, NNE
10:30 Networking & 1:1 Private Consultancy Appointments
All presenters will be available for private, no-obligation discussions on specific programs and challenges. 
11:00 End of Good Morning Meeting



Christian Bille, Systems Engineer at JMP
Christian Bille is a Systems Engineer for JMP. With a background in materials and manufacturing engineering, Bille previously worked as a consulting analyst for pharmaceutical engineering consulting firm NNE. Bille holds a Master of Science and Bachelor of Science in engineering, both from Technical University of Denmark.
Per Vase, Managing Partner at NNE
Per Vase is an acknowledged data analysis expert with more than 30 years of experience. His focus is on applying Six Sigma in good manufacturing practice (cGMP) environments, combining compliance and process optimization efforts to ensure both high quality and low costs. Per Vase holds a Ph.D. in materials science from the Technical University of Denmark and an M.Sc. in experimental physics from Aarhus University.
Louis Meyer, IT Consultant at NNE
Louis Meyer is a data enthusiast with 2+ years of experience in the pharmaceutical industry. Here, his focus is on combining Six Sigma with Good Manufacturing Practice (GMP) and statistical analytical methods with knowledge of the process to ensure the best results for the customers in terms of quality, yield, and cost while still being in compliance. Louis Meyer holds a M.Sc. in Autonomous Systems and a B.Sc. in Production and Manufacturing Intelligence.


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