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

Description :

Recent high-profile recalls and FDA warning letters recall the major cGMP deficiencies in pharma organizations and big name device. Now, FDA is up to take a tougher stance. A single major failing is a clear indicator of lack of target-based/sufficient process V&V execution/planning. Now, you need to consider FDA’s Process validation guidance documents and the ‘must have’ elements in them. You need ICH Q9 for hazards analysis and product/process risk management incorporation, and also need to integrate process validation essentials into quality management system of a company. Effective and real world process V&V is even more important when it comes to today’s industrial environment that is extremely resource constrained.

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