Commissioning and Qualification

Video
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 the regulatory...
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...
Guidance Docs
The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) provides practical guidance on the implementation of a science and risk-based approach for the Commissioning and Qualification (C&Q) of pharmaceutical manufacturing facilities, systems, utilities, and equipment to demonstrate that they are suitable for the intended purpose.
Guidance Docs
Published: July 2014 Pages: 120 Table of Contents Special Pricing for Emerging Economies Water and steam may be used in the manufacture of products, cleaning operations, and laboratory activities within pharmaceutical or biopharmaceutical operations
Training
This online course provides an overview of success factors for Commissioning and Qualification projects. It examines key planning steps at the program level and important system level activities that occur prior to...
Training
This presentation discusses the challenges and benefits of applying a science and risk based commissioning and qualification approach within a contract manufacturing organization, presented by Frank van der Steen, SynCo...
Training
A review of the recent changes in the FDA's thinking on lifecycle based process validation as published in their long awaited update to the 1987 PV guidance. This presentation provides an overview of the key elements of...
Training
Science and Risk-based Commissioning and Qualification - Applying the ISPE Baseline Guide, Volume-5, Second Edition: Commissioning and Qualification....
Training
This interactive classroom course will provide the learner with tools on how to implement a sustainable approach to a risk-based C&Q program....