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:

Manufacturing
Regulatory Affairs
Product Design, Research and Development
Quality Assurance & Control
Medical/Marketing Personnel
Management of Medical Device Operations

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.

Past Participants' Comments

"Good course. Gave me a handle on the issues of regulator compliance." Manan H., Clinical Regulatory Manager, Infinite Biomedical Technologies

"Very useful as an overview. I was able to get a good feel for the important issues from the FDA perspective." Kristen I., Assistant Manager, Business Development, Panasonic Shikoki Electronics

"Very good course to introduce me to the world of medical device regulation and compliance. The class size allowed for very good instructor/participant interaction." George P., Global Registration Manager

"This course provided a great overview of a number of different areas, all of which pertain directly or indirectly to my current position" Diana S., Compliance Specialist, Terumo Medical Corp.

"I feel like I have an understanding of the concepts from this course. Thank you so much!" Melissa M., Quality Technician, Apothecary Products, Inc.

"The course provided an excellent basic overview of FDA regulation. One of the best medical device training courses I have ever attended!" Ron B., Quality Manager, Johnson & Johnson

"The Course Director provided a wealth of information. Her expertise and extensive personal experience was valuable to teaching the class. She was available for questions and provided excellent examples." Heather D., Siemens Medical

"Course director was extremely knowledgeable. Presented subject matter with diagrams which provided extremely comfortable understanding." Jacqueline E., Update Specialist, Siemens Medical

"Excellent delivery; organization of materials. Instructor went above and beyond in course presentation and audience engagements. It was fantastic…thank you!" Stephanie S., RA Specialist III, Dentsply Specialty Materials

"This was a very good all-around course. It provides useful information for all levels of QA experience." Mary M., QA Supervisor, Skytron

"Being new to the medical device industry, this was a good overview from the regulatory perspective. The knowledge gained will enhance my daily activities." Lynda S., Quality, Manager, Documentation & Labeling, Teleflex Medical

"I’ve had this course director before and was very happy to have her again. She is very engaging and encourages participation. She is very knowledgeable and very professional. I hope to have her again in the future." Randy M., Quality Engineer, Orasure Technologies, Inc.