Three Steps to an FDA and ISO Compliant Implementation
Has your company considered moving to a more efficient electronic product development process to manage BOMs, ECOs, Documents and Quality data but hesitated because of concerns about meeting compliance or weren’t quite sure where to begin or what to do?
Attend this webinar to learn from a medical device client, Autonomic Technologies, Inc. (ATI), a medical device company focused on developing innovative therapies for the treatment of severe headache, on why and how they transitioned from a paper-based system to an electronic Product Lifecycle Management (PLM) system.
Guest speaker, Joseph Ko, Director of Quality for ATI will share best practices and the three steps they took to achieve an FDA and ISO compliant implementation.
Topics covered include:
- Paper-based development process pitfalls
- Why ATI chose to automate
- Why ATI chose PLM
- Things to be aware of as a medical device manufacturer
- Three steps to a compliant implementation (prototype phase, validation phase and migration phase)
- Keys to a successful implementation
This webinar will provide an overview of the timeline and resources needed for ATI’s implementation as well as an overview of the entire validation project including: planning, risk management, FDA Part 11 compliance, requirements, and verification protocols.
Thursday the 4th of August 2016; 10:00 – 10:45 hr
