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
Program
| 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 |
Speakers
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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. |
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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. |
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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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