The US FDA Quality System Regulation (QSR) - What Every Executive and Senior Manager Must Know

Event Information
Product Format
Prerecorded Event
Presenter(s)
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Tue, Jun 10, 2014
Length
60 Minutes
Product Description

Do you know all About US FDA Quality System Regulation (QSR)?

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. The current Good Manufacturing Practice (cGMP) requirements for medical devices including in vitro diagnostic devices (IVDs) are set forth in the Quality System Regulations (QSRs). The QSRs are promulgated under section 520 of the Food, Drug and Cosmetic (FD&C) Act.

Both domestic and foreign manufacturers are required to establish and maintain a quality system (QS) for the design and production of medical devices intended for commercial distribution in the United States. The quality system regulation helps assure that medical devices are safe and effective for their intended use.  The US FDA inspects the operations of device firms to determine compliance with the GMP requirements in the QS regulation. To achieve compliance and to remain compliant with the QSRs, it is critical that executives and managers understand and accurately interpret the applicable requirements.

This conference by Dr. David Lim, PhD, RAC, ASQ-CQA will provide great opportunities for executives and managers to become actionably familiar with the quality system requirements applicable to the firms’ device types with improved awareness including the importance of good employment practices and employees’ engagement.  David will share his PASS-IT recommendation/suggestions.  

Training Objective:

  • 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
  • Employment Practices and Employees’ Perception
  • Organizational Culture
  • Recent Consent Decree Case: Causes, Consequences and Resolution.
  • Best Practices to Reduce or Prevent Deficiencies
  • Speaker’s PASS-IT Suggestions/Recommendations

Who Should Attend:CEOs

  • VPs
  • Compliance Officers
  • Attorneys
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Anyone Interested in the FDA inspection Process

Order Below or Call 1-866-458-2965 Today

You can also order through:
Phone

1-866-458-2965

Fax

1-919-287-2643

About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert


Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.


Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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