Validation is an important element of the Quality System Regulations and ISO 13485. This course will cover what processes needed to be validated and what steps you need to take to validate processes. You’ll also learn the essentials of validation planning, protocol writing, and change management.
We’ll also cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices. This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures.
Why You Should Attend:
Failure to validate is a significant cause of 483 observations. Even worse, it can result in customer complaints, adverse events, and even recalls. In this webinar, you’ll learn how to avoid these problems and use validation concepts to ensure process stability and control. You’ll learn the benefits and impacts of validation and how it can benefit your customers and your business. We’ll cover tools and techniques that can help you successfully validate your processes.
Areas Covered in the Session :
IQ, OQ, and PQ, major components of robust Verification and Validation programs – Regulatory requirements
The Master Validation Plan(s)
Individual V&V Plans and their execution
Product Verification and Validation
Process and Equipment V&V, including software
QMS V&V and 21 CFR Part 11
When / How to Use DQ, IQ, OQ, PQ
Incorporating the Hazard Analysis / Risk Management tools of ISO 14971 or ICH Q9
Who Should Attend:
Quality Assurance Departments
Research and Development Departments
Regulatory Affairs Departments
Manufacturing Departments
Engineering Departments
Operations Departments
Production Departments
Validation Departments
Software Departments
Documentation Departments
Consultants
cGMP Instructors