Quality System Regulation for the Medical Device & Biotech Industries

This two-day course has been designed as an introductory course on the Quality System Regulation (QSR) for medical device and biotech personnel. It will assist those who are responsible for compliance with FDA QSR requirements. The seminar is particularly suitable for professionals responsible for compliance, regulatory affairs, project planning, design and development, technology transfer, QA, R&D and manufacturing. Corporate management will find the course helpful in understanding the legal and system requirements necessary for compliance with the QSR and the penalties for non-compliance.

Learning Objectives

Upon completion of this course you will have gained the background knowledge necessary to understand and develop QSR compliant programs for your medical device or biotech product. You will have gained insight into how to prioritize QSR implementation at each stage of development and how to assess your progress. You will also learn what the “deliverables” are at each stage of the development process.

Course Description

This course will introduce you to the Quality System Regulation in the medical devices and biotech industries. Topics covered will include not only the legal requirements for QSR in the Federal Food, Drug, and Cosmetic Act but also how to develop practical applications in order to demonstrate compliance. The faculty consists of individuals with long and distinguished experience in the field.

Throughout this course, the fundamentals of FDA inspections commonly surface. There is special emphasis on discussing procedures and practices of this regulatory agency to help firms comprehend management aspects of FDA inspections.

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COURSE AGENDA

DAY ONE

Introduction to the Course & Participants Questionnaire

Introduction to the QSR

 What is QSR?
 Why must we comply
 Who should comply
 What happens if we don't

Organizational Responsibilities

 Senior Management
 Quality Assurance
 Plant management & staff
 Personnel
 Sales & Marketing

The QS Regulation –

Subpart A – General Provisions
 Scope
 Definitions

Subpart B – Quality System Requirements
 Management Responsibility
 Quality Audit
 Personnel

Subpart C – Design Controls

Subpart D – Document Controls

Subpart E – Purchasing Controls

Subpart F – Identification & Traceability

Subpart G – Production & Process Controls
 Inspection, measuring and test equipment
 Process Validation

Subpart H – Acceptance Activities
 Receiving, in-process and finished device acceptance
 Acceptance Status

Subpart I – Nonconforming Product

Subpart J - Corrective & Preventive Action

Subpart K – Labeling and Packaging Control

Subpart L – Labeling, Storage, Distribution, and Installation

Subpart M – Records
 Device Master Record
 Device History Record
 Quality System Record
 Complaint Files

Subpart N – Servicing

Subpart O – Statistical Techniques

Round-up on Day – Q&A Session.

DAY TWO

A More In-Depth View of the Fabulous Four

 Management Review
 Design Controls
 Process Validation
 Corrective & Preventive Action

Preparing for FDA Inspections & External Audits

 What is QSIT
 Who, what and when
 How to conduct an internal inspection

Regulatory Inspections Survival Guide

 Before the inspection
 During the inspection
 After the inspection

Further Reading and Useful References

Final Round-up and Q&A Session and Feed-back