2016 - Webinar on FDA's Guidance on Process Validation for Drugs and Biologics

We will focus on US FDA documentation models in various applications that are field proven ? including, ERP, wherever cGMP data/records are collected, used, stored and retrieved, and process/equipment and test/lab equipment control. The session will:
Address the U.S. FDA's key January 2011 Process Validation Guidance Document
Provide 3 key steps to process lifetime compliance
Discuss the FDA’s newer and tougher regulatory stance on V&V requirements
Review a company's Process Verification and Validation system for major cGMP deficiencies
One major failing is lack of sufficient or targeted risk-based V&V planning and associated documentation. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management, allows the development of meaningful product quality-specific process validations. Also the roles of different V&V protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources. Our V&V “model” simplifies process and equipment, et al, hardware and software VT&V, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 are also considered.
Areas Covered in the Session :
The FDA’s Process V&V Guidance
Working toward homogeneity within and between batches ? a key goal
The 3 Key / Lifecycle considerations
V&V Master Planning
Field-proven V&V “models” ? useful for all V&V
Hardware and software V&V considerations
Developing test cases / scripts
“Risk Based” -- what it means in V&V and how it should be used
Who Will Benefit:
This training applies to personnel / companies primarily in the pharmaceutical, devices, biologics and Combination Products fields. The employees who will benefit include:
Senior management
Quality Assurance
Reulatory Affairs
Engineering
Research & Development
Production
Operations
Consultants
All personnel tasked with product, process, validations and cGMP responsibilities