Overview of FDA Regulatory Compliance for Medical Devices

• 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 an 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
The 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 the 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
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COURSE AGENDA

FIRST DAY

Introduction

• Objectives
• Seminar Overview

Introduction to FDA

• FDA Organization
• Device Regulatory History
• Who are the Players

Product Approval Processes

• Premarket Notification
• Premarket Approvals
• Investigational Clinical Studies

FDA Reporting Systems

• Registration and Listing
• US Vigilance System- MedWatch
• Corrections and Removals

US Vigilance System

• Types of Programs
• Inspectional Outcomes

Enforcement Tools and Actions

• Types of Actions
• Warning Letters, Civil Money Penalties

Enforcement Statistics

• AAC analysis of warning letters

Question and Answer Session

SECOND DAY

Quality System Orientation

• QSR Scope, Definitions and Requirements
• ISO 13485 comparison to QSR

Quality System Inspection Technique (QSIT)

• Approach
• Objective
• Key Subsystems

Do’s and Don’ts

• Risk Areas You Want to Ensure
• Staying Away from Red Flag Areas

Why Internal Audit Systems Fail

Question and Answer Session