Webinar On IQ, OQ, PQ in the Verification and Validation Process

Description :

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.

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent product / equipment / process V&V requirements and execution. And now the FDA is taking an even tougher stance.

Why do companies need robust V&V?

What are the "must have" elements from  the CGMPs and best practices?

How do you define and use IQ, OQ, PQ, or their equivalents?

How do ISO 14971 and ICH Q9 for hazard analysis and product risk management factor in and assist to allocating limited company resources?

How can these be integrated into the company's quality management system?

While focused on CGMP compliance, it is suitable for ISO 13485 and ISO 9001 (international / global) compliance as well.

Areas Covered in the Session :

IQ, OQ, and PQ, major components of robust Verification and Validation V&V 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, or ASTM E2500 Equivalents

The 11 Elements of the FDA's Software VT&V "Model"

Incorporating the Hazard Analysis / Risk Management tools of ISO 14971 or ICH Q9

How to Avoid recent compliance problems

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to review and modify their company's planning and execution of verification and validation, based on a proper understanding of the roles of IQ, OQ, and PQ, or equivalent terminology. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:

Senior management

Middle management

Research & Development

Engineering

Software

QA / RA

Manufacturing

Operators

Consultants

cGMP instructors

All personnel involved in verification and/or validation planning, execution and documentation.