Commissioning and Qualification

Video
Why is commissioning & qualification important? Is qualification the same as verification? What is a key factor when implementing a risk management approach to commissioning and qualification? What is a common...
Video
Complimentary Extended Learning Learning Level: Intermediate This webinar session is a follow-up to last summer’s popular webinar, “Polishing an Old Gem: Commissioning & Qualification Baseline Guide Update” which gave...
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Commissioning and Qualification (C&Q) are terms and processes related to the manufacturing of pharmaceutical or biotechnology products. Each term represents a scope of work that is part of a larger framework for making...
iSpeak Blog
This blog is the last of four posts addressing questions received during the August 2019 webinar summarizing the introduction of 2nd Edition, ISPE Baseline Guide Vol 5: Commissioning and Qualification. The guide provides a well-defined framework for a...
iSpeak Blog
This blog is the third of four posts addressing questions received during the August 2019 webinar summarizing the introduction of 2nd Edition, ISPE Baseline Guide Vol 5: Commissioning and Qualification. The guide provides a well-defined framework for a...
Technical
Over the years, the roles and responsibilities of engineering and quality/validation personnel for commissioning and qualification (C&Q) activities have evolved. Now more than ever, commissioning and qualification approaches based on quality risk management (QRM) principles rely heavily on...
Video
Complimentary This webinar will introduce the revision to the ISPE Baseline Guide Vol 5: Commissioning and Qualification. The guide was first issued in 2001 and reflective of that time. With emerging markets, changes in...
Guidance Documents
01 July 2019
News & Press Releases
ISPE announced the release of their latest guide, ISPE Baseline® Guide: Commissioning and Qualification (Second Edition). This Guide provides practical guidance on the implementation of a science and risk-based approach for the commissioning and...