Who Should Attend
This course has been developed for those who are involved with ensuring regulatory compliance for medical devices. Participants ranging from new hires to industry veterans who need a baseline understanding of medical device regulatory compliance issues will benefit from this course.
Typical attendees include those in:
- Manufacturing
- Regulatory Affairs
- Product Design, Research and Development
- Quality Assurance & Control
- Medical/Marketing Personnel
- Management of Medical Device Operations
Additionally, this course will be of great value to experienced professionals looking for the latest trends in regulatory mandates and compliance challenges.
Learning Objectives
This course is specifically focused on the law, regulations and policies set by the FDA for the pre-market approval, manufacture and post-marketing compliance of medical devices. The course content is designed to provide an in-depth understanding of the paths to obtaining agency approval; how the FDA performs inspections; the type of controls, systems and documentation they expect to see in place; and the variety of outcomes from each inspection. The course also covers the remedies available to show inspectors that manufacturing processes are in full compliance with quality system requirements.
Course Description
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