Topics
- ICH guidelines Q1 series, Q2, Q5C
- 21CFR211
- Potential sources of Analytical Audit templates
- Guidance for Industry: Analytical Procedures and Method Validation
- Role and responsibilities of a Lead Auditor
- Review of recent 483’s with relevance to analytical laboratory activities and expectations
- Key aspects of the role and key players involved in an audit-auditor and auditee perspective
- Role and responsibilities of the Analytical Method Subject Matter Expert
- Analytical Audit- from planning to reporting to closing
- Audit preparation activities and Laboratory preparation activities
Who should Attend
Participants from contract testing labs and pharmaceutical/biopharmaceutical companies, including Quality Assurance, Laboratory Staff - Director, Manager, Supervisor, Audit Team Members, Quality Control, IT and Documentation.
