Validation is one of the most confusing and misunderstood compliance requirements. Device manufacturers commonly ask when validation should be performed, what processes require validation, and how much validation is needed. To add to the confusion, you will receive a variety of different answers to these questions depending on whom you ask.
The objective of my presentation, titled, “Validation: How much is needed and where to begin?” is to provide attendees with an overview of the regulatory requirements that exist and how to interpret these requirements for applicability to their specific products and processes.
My presentation will cover:
- Requirements for Validation, FDA & ISO
- Enforcement Activity
- The Basics
- Where to Begin
- Where to Find Assistance and Additional Information
Admission to the conference is free for qualifying implantable device manufacturer employees. Otherwise a registration fee will apply. Today is the last day to register for a special early-bird registration discount.
Feel free to get in touch if you’ll be at the conference. I look forward to connecting.
Steve can be reached at email@example.com.