Topics
- Standards-Q2R1, FDA Guidelines
- Definitions of Terms-qualification, validation, verification, co-validation, intended use
- Requirements for Execution
- Requirements for Entry-what is needed in order to start a qualification or validation
- Pitfalls and potential resolutions
- Documentation needs-SOPs, Forms, Worksheets, Data Output, Protocols, Reports
Who should Attend
Attendees from BioPharmaceutical and Pharmaceutical companies involved in Analytical Validation, Analytical Development, Quality Assurance, Quality Control, Validation Team members, Team Leaders, review/approval of validation protocols and reports, planning development and validation activities.
