This course teaches the basics of validation process and will learn to write practical protocols that are regulatory compliant At the end of the course the participants would have understanding of the following:
- The Regulatory requirements and draft guidelines that apply to validation
- The business case for validation
- Definitions of Protocols & SOP’s
- Definition of critical validation parameters I acceptance criteria
- Process characterization
- Definition & Assembly of a Validation Master Plan (VMP)
- Installation Qualification (IQ)
- How to execute the IQ
- IQ Acceptance Criteria
- Operational Qualification (OQ)
- How to execute the Operational Qualification (OQ)
- Operational Qualification (OQ) Acceptance Criteria
- Operational Qualification (OQ) Report
- Performance Qualification (PQ)
- How to execute the Performance Qualification (PQ)
- Performance Qualification (PQ) Acceptance Criteria
- Performance Qualification (PQ) report
- The SOP’s which must be written and followed during a validation process
- What must be included in Validation Final Report (VFR)
- Guidelines on sampling plans. How many samples are enough?
- How to track action items and establish accountability
- Training requirements
- Parameter checks and balances to use after validation
- Standards or Knowns
- Statistical Process Control (SPC)
- Calibration and Preventive Maintenance
- Maintaining the process in a validated state
Level: Basic. Participants expected to have knowledge of GMP
Duration: 1 Day
Training Code: TC-OT-0001

