Please download one of these browsers:
Keep your browser version up-to-date for a fast, secure, web experience.
1 hour online/Zoom session: Discuss FDA Environment, 21 CFR Part 11 & PIC/S Annex 11. Explore areas of control within your company. Then discuss specific Annex 11 clauses relevant to your requirements.
1 hour online/Zoom session: Walk through a Computer System Validation Master Plan and an Infrastructure Qualification Plan to highlight the importance of the overarching validation framework.
2 hour online/Zoom session: Work through a macro risk assessment, then use it to discuss a CSA validation approach. Work through a full project validation example (validation plan, requirements, design and testing) highlighting how knowledge gained at the system testing can flow back into the end-user testing.
.png?lmsauth=6e99c488c4293c9c01f31dc24f514d67339eb26d)
.jpg?lmsauth=6689c7d166df6406923cfa8637465e5cbcf55047){kind=small}