Track 2: Laboratory
There are common threads in many compliance problems experienced in the laboratory. Do you know what they are?
Validation of a computerized system is just as critical in a laboratory as it is in Manufacturing. Gain a better understanding of what the Regulatory Agencies are looking for in relation to Quality Systems. Learn through case studies and get immediate feedback from subject-matter experts and FDA representatives on how to take a risk-based approach to the validation of laboratory computerized systems with GAMP®5.
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Apply new risk-based concepts related to laboratory systems validation as presented in the new GAMP Good Practice Guide
Who Should Attend
- GAMP COPs
- Laboratory Managers
- Quality Assurance Professionals