2021 - Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing

Day 01(9:30 AM - 5:30 PM EDT)
9:30 AM: Session Start Time
Welcome, Introduction to the course and Speaker
Regulatory requirements and expectations for Equipment Qualification
Europe
FDA
Global harmonization and expectations
Definitions
Management of Documents, Documents required
Validation Policy
Validation Master Plan (VMP)
Documents Equipment Qualification
SOPs
Responsibilities
Validation Team
Presumption for Qualification/Validation
General Aspects of Qualification
Qualification Phases, DQ, IQ, OQ, PQ
Qualification of existing systems and equipment
Requalification/Validation
Performance Qualification
SOPs
Writing a qualification protocol, content
Executing a qualification
Tests, and data
Documents
Writing a qualification final report
Questions
Day 02(9:30 AM - 5:30 PM EDT)
Performance of a Process Validation
SOPs
Writing a Process validation protocol
Guidelines on validating analytical methods
Content and execution
SOPs
Writing the validation plan
Methodology and performance
Report writing for method validation
Presumption for validation
Support of Equipment Qualification and Process Validation
Quality Management System
Risk Analysis
Calibration/Maintenance
Change Control
Auditing equipment qualification and process validation
External Equipment Qualification and process Validation
Contract Manufacturer
Qualification/Validation by a supplier
Review of FDA warning letters
Case Study Exercise from current FDA Warning Letters
Theoretical Case exercises
Questions