Tuesday, August 9 | 11:00AM ET
Presented by: Stephen Ferrell, Managing Director, Americas & Asia, CompliancePath Ltd.
Since 2008 GAMP®5 has been the global standard for computer system validation and assurance in the regulated life sciences. Since that time there has been an unprecedented technological leap forward that has provided the pharmaceutical and medical device industries with a foundation that will facilitate unprecedented process digitization and therapeutic innovation. With these new technologies in mind the GAMP® 5 2nd edition was released in July 2022 in order to provide practitioners across the IT and software verticals with the necessary process tools and understanding to achieve meaningful risk-based compliance that ultimately fulfills the ‘FDA’s least burdensome’ mandate. This webinar provides our take on the updated content within the guide and it’s potential application.
Top Ten Reasons to attend.
1. Learn how Agile practices can facilitate compliant system implementations
2. Understand how software tools can digitize validation and assurance activities
3. Insight into the blockchain and it’s potential application is a regulated context
4. Discussion of GAMP® 5’s take on AI and ML for regulated software systems
5. How to leverage IT Infrastructure is a risk based way
6. An encouragement to apply critical thinking to validation and assurance activities
7. How GAMP® 5 support Pharma 4.0 initiatives
8. Learn how the GAMP® 5 approach for requirements creation and management
9. Understand the applicability of GAMP® 5 practices to Electronic Production Records
10. Grasp how GAMP® 5 & CSA intersect and compliment each other