Verification vs Validation in Regulated Industries

The meanings and regulatory requirements of the terms “verification” and “validation” are often confusing to engineers and even some regulatory professionals. FDA regulations as well as European standards such as ISO 13485:2003 require both verification & validation documentation throughout these regulations and standards. The terms apply to design control, process control and others. This presentation will define and explain the differences (& similarities) in these terms and how they apply to regulated industries as well as the consequences of poor adherence.

Why Should You Attend:

An inadequate validation in Design Control often results in failure to meet the needs of the user, resulting in poor sales and wasted design efforts.

Much can be learned from FDA’s Warning Letters on FDA’s regulations including Design Control 21CFR 820.30, Corrective and Preventive Action (CAPA) 21CFR 820.100 as well as Production and Process Control 21CFR 820.70. Besides the damage to the company from posted, public adverse interaction from FDA, there is the financial damage to the bottom line from recalls and waste from inadequate production & processes. Adherence to the requirements of verification and validation will prevent this and will improve the efficiency of your processes. The bonus is you will save money and add to the bottom line instead of taking away $$ from the bottom line.

Areas Covered in the Webinar:

• Design Control
• Corrective & Preventive Action
• Production & Process Control
• Recalls
• Warning Letters
• FDA’s Quality System Requirements
• ISO 13485:2016

Who Will Benefit:

• Director, QA & Regulatory Affairs
• QA Managers
• Director of Operations
• VP Engineering
• Design Engineers
• Process Engineers