This course discusses the FDA’s regulatory authority for approving medical devices prior to marketing and the compliance programs used in enforcing its authorities during the manufacture and post-marketing reporting systems. It also provides FDA strategies towards inspections of manufacturing sites, and compliance actions that may result from these inspections. The course provides the attendees with the most important regulatory resource materials needed to understand agency policies and enforcement actions.
Issues to be covered include:
- Structure of the FDA and current FDA regulatory compliance practices - how to work with FDA investigators
- The regulatory approval process – "what the FDA is looking for" in 510ks, PMAs and other pre-approval applications
- The scope of FDA’s compliance programs, policies and potential enforcement actions
- Discussion of post-marketing notification and reporting programs
- Strategies for development of an in-house compliance program for GMPs which ensure successful inspectional outcomes
- Recent FDA enforcement statistics
Who Should Attend
This training course has been developed for those who are involved with ensuring regulatory compliance for medical devices. The course is primarily geared towards those who are new to industry or require a basic understanding of medical device regulatory compliance issues. The training may be of interest to industry veterans who need refresher training on these topics.
Typical attendees include those in:
- Regulatory Affairs
- Product Design, Research and Development
- Quality Assurance & Control
- Medical/Marketing Personnel
- Management of Medical Device Operations