• Manufacturing
• Regulatory Affairs
• Product Design
• Research and Development
• Quality Assurance & Control
• Development and Preparation of Submission Material
• Laboratory Operations

This course is designed for individuals who require in-depth knowledge of regulatory affairs and compliance issues.  The course content is continually updated by our expert Course Directors.  When delivered as an in-house program, this course is fully customizable to meet the specific needs of an organization, department or employees functional responsibility.



Learning Objectives

This course is specifically focused on the law, regulations and policies set down by the FDA for the manufacture of medical devices.  It will provide each attendee with the background and knowledge necessary to understand the organization, structure and role of the FDA as it relates to pre-marketing approval processes and compliance issues for 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 information they are looking to see in place and the variety of outcomes from each inspection.  The course also covers the remedies available to satisfy inspectors that manufacturing processes are fully in compliance with quality system requirements.



Course Description

This course discusses the Agency’s regulatory authority for approving medical devices prior to marketing and the compliance programs used in enforcing its authorities. It also provides FDA strategies towards inspections of manufacturing sites and compliance actions that may result from these. The various regulatory processes are presented including the major enforcement tools such as warning letter, injunctions and civil money penalties. The course provides the attendees with the most important regulatory resource materials needed to understand agency behavior. 

Issues to be covered include:

• Structure of the FDA
• 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 GMP’s and ensure successful inspectional outcomes.
• Recent FDA enforcement statistics

View Course Agenda

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

“Excelent 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.