Process Validation

Video
Guide contributor (co-lead) Robert Beall, PMP, ProPharma Group, shares why process validation is an essential part of the pharma industry and how you’ll benefit from the ISPE Good Practice Guide: Practical Implementation...
Video
ISPE training instructor, Maurice Parlane, B Tech MIT, New Wayz Consulting Ltd., CBE Pty Ltd., shares the top three takeaways you will gain by attending ISPE process validation training. Register Now For even more on...
Discussion Papers
This discussion paper proposes ideas for answering the questions about the application of the lifecycle approach to PV to Biotech product...
Discussion Papers
Authors: Mette Bryder (Lundbeck), Harold Etling (Eli Lilly), Jeff Fleming (Pfizer), Yanhui Hu (Abbott), Peter Levy (PL Consulting) 1 Introduction...
Discussion Papers
This discussion paper proposes ideas for answering the questions “How is Stage 3 monitoring and testing following PPQ determined, as part of the...
Discussion Papers
Numerous guidances are available from regulatory and industry sources concerning process validation; however, very few provide information regarding...
Discussion Papers
Authors: David Dolgin (PSC Biotech), David Hughes (Sandoz), Matthew McMenamin (GSK), Parab Parkash (BMS), Domenico Schiavone (Fresenius-Kabi), Chris...
Discussion Papers
Authors: Carly Evans (Akebia Therapeutics), Katherine Giacoletti, (SynoloStats LLC), Declan Hurley (Lilly), Robert Ievers [Co-Lead] (Merck), Matthew...
Discussion Papers
Authors: Robert Beall (ProPharma Group), Penny Butterell (Pfizer), Kurtis Epp (CSL Behring), Lois Hintz (Corden Pharma), Russell Miller (Lilly), Rusty...
iSpeak Blog
We are in a period of unprecedented change – some would even say disruption in the types of medicines and technologies adopted. This comes in an environment with ever increasing demands to improve time to market and manage resources. Process validation...