Topics
- Most common inspection problems
- Lab equipment requirements for calibration and qualification
- Development of an effective equipment qualification master plan
- USP Chapter [1058]: Analytical Instrument Qualification
- Allocating equipment to qualification categories A, B and C
- Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification
- Going through the category example list
- Qualification and documentation requirements for each category
- Approach for automated systems (incl. firmware/computer systems)
- Approach for existing systems
- Documentation requirements
- Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
- Update on the new revision of USP [1058]
Who should Attend
Professionals from Pharmaceutical companies, API manufacturers, Clinical testing laboratories and Contract manufacturers and laboratories, including:
- Analysts and Lab Managers
- QA Managers and Personnel
- Regulatory Affairs
- QA Managers and Personnel
- Documentation Departments
- Training Departments
- Consultants
