ISPE Baseline® Guide: Commissioning and Qualification (Second Edition)




2nd February 2021

Save The Date !




This Techtime will focus on the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition). The guide 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. The Techtime will review the application of science and risk management approaches, a focus on product and process understanding, and the application of Quality by Design concepts.

This intention of Risk based verification is to offer a compliant, integrated C&Q approach to making the qualification process efficient and cost-effective. This approach includes a System Risk Assessment process that identifies Critical Aspects and Critical Design Elements. We will discuss industry best practices regarding C&Q and present concepts that can assist organizations in meeting current regulatory expectations for system qualification. The intent of Risk Based verification is to help the pharmaceutical industry simplify and improve the C&Q process by bringing the “best of the best” GEP and C&Q practices.

Official language of the conference : English
No simultaneous translation

Tuesday, February 2nd, 2021

Connection and welcome of the attendees

Conference "ISPE Baseline® Guide: Commissioning and Qualification (Second Edition)"
Alice REDMOND, Commissioning Agents Inc.
This Techtime will discuss what is essential to an integrated risk based C&Q effort, such as:
• How to apply Quality Risk Management to C&Q
• Best practices for User Requirements Specification, System Risk assessment, Design Review, Design Qualification, and acceptance and release
• Efficient use of a change management process to support C&Q
• Good Engineering Practice documentation standards
• We will discuss a benchmark of current C&Q practices by the industry to give an indication of current trends
• Quick Wins – in Implementing Risk based C&Q.

End of the event


We use TEAMS (Microsoft Office) or ZOOM software to conduct our webinars. These secure and free collaborative platforms allow you to follow and interact with our expert, guests and other participants in the best conditions. These software are compatible with all operating systems (Windows / ios) and offer an online version compatible with many browsers (Internet Explorer, Chrome, Firefox, Safari, etc.).).

The A3P team stays at your disposal to accompany you and ensure the proper functioning of your system remotely. To do so, all you need is a computer, ideally with a headset (optional you can use your computer’s micro/audio system) and a stable internet connection.

A few days before the date of the webinar, you will receive an email invitation to access the TEAMS or ZOOM platform. On the “D” day, you will just have to connect via the link. Please make sure to have a quiet and comfortable place to follow this module in the best conditions.


For any information, please contact Nina Chatré :

Phone : +33 7 58 68 94 49
Fax : +33 (0)4 37 28 30 60
Email :
Address : A3P, 30 rue Pré-Gaudry – Lyon 69007