The US FDA Quality System Regulation (QSR) - What

Every Executive and Senior Manager Must Know

This conference is intended to discuss US FDA Quality System Regulation (QSR).In
particular, it is intended to talk about what every executive and senior manager must know.

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Presenter
Dr. David Lim
Copyright 2014 REGULATORY DOCTOR. All Rights Reserved.

Disclaimer

The
contents
of this
presenta
tion:

do not represent and should not be

construed to represent the host or policy.
are my own views, interpretation and
understanding of the relevant and
applicable information (laws, regulations,
standards, rules and/or guidances).
may be most helpful and effective when
used in conjunction with your professional
judgment and discretion.
are not all inclusive.

Copyright 2014 REGULATORY DOCTOR. All Rights Reserved.

Objectives

Learn applicable Laws

Understand Quality System Regulations
Get definitions
Quality Management Systems: Requirements
Quality Management Sub-systems: Requirements
Gain an insight to understand the interrelationship between Sub-Systems
Learn how to Establish and Maintain Quality Management Systems
Bridge big gaps in our understanding and interpretation of the QSRs
Solve your major and Common Misconception
Common Deficiencies-Easily Avoidable: Causes and Consequences
Non-Compliance: Causes and Consequences
Solutions to Non-Compliance
FDA 483s and Warning Letters
Executives and Managers: What They Must Know
E ploy e t Practices a d E ployees Perceptio
Organizational Culture
Recent Consent Decree Case: Causes, Consequences and Resolution.
Best Practices to Reduce or Prevent Deficiencies
Speakers PASS-IT Suggestions/Recommendations
Copyright 2014 REGULATORY DOCTOR. All Rights Reserved.

FDA Inspection Authority,

Regulation, and Manuals
Federal Food, Drug, and Cosmetic Act (the Act)
Section 704 of the FD&C Act for drugs and devices

FDA Regulations and Additional Laws Enforced by the FDA Code of Federal
Regulations (CFR) - Title 21
Section 351(c) of the Public Health Service Act (PHSA) for licensed biologics
Section 361 of the PHSA for tissue products

Investigations Operations Manual (IOM)

IOM Section 5.5.6 CDER BIMO; IOM Section 5.6.1.4 CDRH BIMO; IOM Section 5.7.2.8 CBER BIMO (See IOM 5.5.6)

Guides to Inspections (e.g., computer issues and BIMO of IVDs)

Compliance Program Guidance Manual (CPGM)

Compliance programs (program plans and instructions) directed to field personnel; Biologics (CBER); Bioresearch Monitoring (BIMO);

Devices/Radiological Health (CDRH); Drugs (CDER); Food and Cosmetics (CFSAN); and Veterinary Medicine (CVM)

Compliance Policy Guides (CPG)

Regulatory Procedures Manual (RPM)

Contains FDA compliance policy and regulatory action guidance for FDA staff.
Contains FDA regulatory procedures for use by FDA personnel. A reference document for enforcement procedures and practices.

Staff Manual Guides (SMG)

The Agency directives that document organizations and functions, delegations of authority, general administrative operations, and
programs of the FDA.
Copyright 2014 REGULATORY DOCTOR. All Rights Reserved.

Quality Management System (QMS)

A firm (YOU) should consider:

Your business goals and purpose

Required or Voluntary

21 CFR Part 820

ISO 13485, ISO 9001, etc.
ONE SYSTEM (Integrated)

QMS should be commensurate with:

The specific medical devices (risk-based)
Tailored to:
particular processes (e.g., manufacturing) and device(s); and
size and complexity of organization

Copyright 2014 REGULATORY DOCTOR. All Rights Reserved.

To see the complete presentation check the

below link:
http://www.audioeducator.com/pharma-biotech/us-fda-quality-systemregulation-06-10-14.html

Copyright 2014 REGULATORY DOCTOR. All Rights Reserved.