Commissioning and Qualification

News & Press Releases
01 July 2019
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
Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and....
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,....
Training
This classroom course is designed to improve the way in which the industry delivers regulated manufacturing capacity: improving the ability to meet....