Analytical Methods, Process, Equipment, Cleaning, and Sterilization Validations

Description:

Review a company's Test Method and Design Verification and Validation system for major systems: Test Methods, Equipment, Cleaning, Process and Sterilization V&V. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 / ICH Q9 for hazard analysis and product risk management, allows the development of science-based verifications and validations. Also the roles of different V&V protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents. Part 11, cybersecurity and software VT&V are also addressed.

Why Should You Attend:

FDA Warning Letters and recent high-profile recalls indicate deficiencies in verifications and validations of Analytical Test Methods, Process, Cleaning, Equipment and Sterilization Validations. What are the regulatory and documentation requirements? How does risk-based safety V&V planning / execution function and how documented per ISO 14971 and ICH Q9? Various Test Case formats and Test Report / Protocol examples are provided.

Areas Covered in the Webinar:

Participants will learn how an effective Verification and Validation plans/systems for test menthods, equipment, process, cleaning, and sterilization are a critical requirement to the movement toward a risk-based approach to compliance and product safety.

Issues to be covered include:

• Equipment, process, cleaning, sterilization and test methods validations
• FDA V&V guidelines
• Basic GLP / CGMP requirements
• Understand the scope of regulations governing these key V&V areas
• Develop the various V&V test cases and Report formats for the key V&V areas discussed
• Learn how to construct, implement and deploy a Validation Master Plan

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to review and modify their Validation Planning and Execution / Documentation, meeting US FDA and EU MDR / EMA requirements. These principles apply to personnel / companies in theDevice, Pharmaceutical, Diagnostic, and Biologics fields and Combo products. The employees who will benefit include:

• Senior management
• R & D
• Quality Assurance / Regulatory Affairs
• Production
• Engineering, including Software
• All personnel involved in verification and/or validation planning, execution and documentation.