Change Control for Medical Devices Current Best Practices for FDA-Compliant Systems
Product DetailsHeld Dec. 6, 2006
Poorly managed change control systems can result in patient injury, product recall or rejected product lots — potentially costing manufacturers millions. They continue to be among the most difficult systems to manage in an FDA-regulated environment.
Let Barbara Immel guide you through the FDA's regulatory and ISO standard requirements concerning change control, current FDA inspection trends and changes requiring prior FDA approval. She'll address change control from a manufacturing and quality assurance perspective to help you avoid costly mistakes.
The FDA is currently working on minimizing the number of change control submissions it receives. In this 90-minute audio CD/transcript, discover what these and other changes at the agency mean to you.
Back by popular demand! This successful program on change control systems had more than 300 listeners earlier this year. Attendees asked for specific advice for medical devices. FDAnews is pleased to comply with these requests.
You will discover:
- Medical device regulatory and ISO standard requirements concerning change control
- FDA design control requirements
- What FDA inspectors are trained to look for in change control systems, requests and follow-up
- Current FDA inspection trends concerning change control
- Recommended FDA guidance documents and resources on change control
- Best practices for change control from industry peers
- How to manage and implement effective change control
- What types of changes must be submitted to the FDA
- Techniques to avoid common change control problems
- Real-world ideas for working change control systems, procedures and forms
Don't miss this opportunity to get expert guidance on best practices for medical device change control systems.