Computer Systems Validation

PharmOut has been training on Computer Systems Validation since 2008, much has changed recently, surprisingly Data Integrity remains a hot topic with regulators. This course examines the latest GAMP 5 second edition, including the new chapters on cloud storage, Artificial Intelligence, Machine Learning, and Blockchain) as well as recent developments, i.e. FDA’s draft Computer Software Assurance (CSA) Guideline, and of course the PIC/S Data Integrity guidance PI041. Aside from shifts in regulations, there have been significant technological shifts too, as part of Pharma 4.0TM, we have Software as a Medical Device (SaMD) and Software in a Medical Device. The computer systems validation course will cover both medical device and medicine regulations and recent challenges posed by emerging technologies like IoT’s.

The course provides a broad overview of the regulatory requirements for computerised systems and is designed for pharmaceutical and medical device professionals seeking training on a practical and cost-effective approach. We will cover the risk-based approach and a detailed overview of various CSV methodologies including those based on the ISPE Good Automated Manufacturing Practice (GAMP®5) guidance, the waterfall and V models, all meeting EU GMP & PIC/S PE 009 Annex 11 and the US FDA 21 CFR Parts 210, 211, 820 and 11.

“There are major business benefits in having a defined process that delivers systems that are fit for intended use, on time, and within budget. Systems that are well defined and specified are easier to support and maintain, resulting in less downtime and lower maintenance costs…”

ISPE GAMP® 5 “A Risk-Based Approach to Compliant GxP Computerized Systems”