IQ, OQ, PQ in the Verification 2022 - Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process
Product Id : MD3589
Presenter : Susanne Manz
Scheduled On : March 10 2022 1:00 pm US/Canada Eastern Time - ET
Duration : 3 Hours
Validation is an essential element of the Quality System Regulations and ISO 13485. This course dwells into the processes that need to be validated and what steps are needed to validate the processes. You’ll also learn the essentials of validation planning, protocol writing, and change management.
We’ll take a deep dive into all the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including industry tips and best practices. This session will discuss the considerations of IQ, OQ, and PQ and their counterparts for processes, equipment (production and test), product, including cGMP e-records / e-signatures.
Why You Should Attend:
Failure to validate is a sure-fire way to a 483 observation. Worse still, it can result in customer complaints, adverse events, and even product recalls. This 3-hour virtual seminar will guide you on how to avoid these problems and use validation concepts to ensure process stability and control. Effective validation can benefit your customers and your business; learn the benefits and impacts of validation from this session. We’ll cover how to effectively validate your processes by using current tools and techniques.
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