Paperless CQV and Baseline Guide 5 скачать в хорошем качестве

Paperless CQV and Baseline Guide 5

About The Webinar Pharmaceutical Manufacturers are required to demonstrate facilities, systems, utilities, and equipment are suitable for purpose. The ISPE Baseline Guide 5 (Second Edition) provides a 'best of the best' practical guidance on the implementation of a science and risk-based approach for Commissioning and Qualification (C&Q). As the pharmaceutical industry adopts paperless validation systems for C&Q, understanding how to employ Baseline Guide 5 in paperless C&Q processes presents unique challenges and opportunities. During this webinar, understand the key principles of the ISPE's Baseline Guide Volume 5, how to use paperless validation software to embed its best practices. Part 1: ISPE Baseline® Guide Volume 5-Commissioning and Qualification: The Industry Best Practice Part 2: How Paperless Validation Software Enables ISPE Baseline Guide 5 Part 3: Case Study: Building a Paperless C&Q Process upon Baseline Guide 5 Joon Leong Ng, Senior Manager- NoDeviation LLP. With 15 years of experience across APAC region with focus on Commissioning, Qualification & Validation in the pharmaceutical industry. Throughout the years, Joon has gathered extensive hands-on as well as management experience. He also possesses in depth knowledge in Regulation & Guidelines, Project Management, Change Control Process and Lean Leadership. Sarah Grogan, Lead Process Engineer, Kneat Solutions Sarah is a Paperless Validation Subject-Matter-Expert, with over 6 years' experience deploying and configuring paperless validation solutions for some of the biggest life sciences companies in the world. A Process Engineering specialist with Kneat Solutions, Sarah has a background in Biomedical Engineering and is currently based in Limerick, Ireland.