Overview Of FDA Regulatory Compliance For Medical Devices

Who Should Attend
This course was developed for those who are involved with ensuring regulatory compliance for medical devices. This course is designed for individuals who require in-depth knowledge of regulatory affairs and compliance issues.

Typical attendees include those in:

• Regulatory Affairs, Quality Assurance & Control
• Product Design, Research and Development

Manufacturing

This course is designed so that you will: 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.

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. Issues to be covered include:

• Structure of the FDA
• Current FDA regulatory compliance practices Recent FDA enforcement statistics 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.

FIRST DAY
Module 1: Introduction
Objectives
Seminar Overview
Introduction to FDA
FDA Organization
Device Regulatory
History Who are the Players
Module 2: Product Approval Processes
Premarket Notification
Premarket Approvals
Investigational Clinical Studies

DAY TWO
Module 5:Quality System Orientation
QSR Scope, Definitions and Requirements
ISO 13485 comparison to QSR
Module 6: Quality System Inspection Technique (QSIT)
Approach
Objective
Key Subsystems
Module 7: Do’s and Don’ts
Risk Areas You Want to Ensure
Staying Away from Red Flag Areas
Module 8: Why Internal Audit Systems Fail
Question and Answer Session
Questions & Wrap-Up
When delivered as an in-house program, this course is fully customizable to meet the specific needs of an organization.