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Quality is always the result of excellent work without compromise.​

MMD-111    An Overview of 21 CFR 820 & US FDA's Medical Device GMP

  • Overview
  • Course Objectives
  • Course Content
  • For Whom
  • Schedule and Hours
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>
This course introduces the concepts needed to understand, develop, and implement a quality system as outlined in the 21 CFR 820 Quality System Regulations. It provides understanding the legal requirements and US FDA’s expectations relating to cGMP Quality System Regulation (QSR), as well as the cost of noncompliance.

Participants will be led by an experienced trainer whom, in addition to being a medical device quality systems auditor and product approval reviewer, has nearly 3 decades of assessment, training and quality assurance as well as management system development experience. Participants will engage in exercises and discussion points, including considerations in harmonizing these requirements and those of the IMDRF with respect to medical devices regulatory compliance as well as failures encountered by manufacturers during plant inspections.
This course will provide participants with an overview of the FDA and intention of the 21 CFR Part 820, current requirements of the 21 CFR Part 820, working knowledge in application to their organization as well as ability to prepare and host the FDA inspection.
  • Background of 21 CFR Part 820
  • Quality System Regulation
  • Best Practices to Implement each cGMP QSR
  • How to get ready for FDA Plant Inspections
  • Introduction
  • Quality System Regulation  
  • cGMP Implementation
  • The FDA Inspection Process 
  • Anyone involved in defining, planning, or implementing a 21 CFR 820-based cGMP QSR
  • Management representatives
  • Implementation team members
This is a ​2-days programme.
​

This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.
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​All of our training modules are claimable under HRD Corp.

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©  Ampro Solutions Sdn Bhd 2023
  • Home
    • About Us
    • Authorized Training Partner
  • Our Services
    • On-Site Training
    • Off-Site Training
    • Coaching
    • Audit Support
    • Consultation Services >
      • Energy Management >
        • Remote Power Management Services
      • Management Systems >
        • ISO 50001 Energy Management System
        • ISO 9001 Quality Management System​
        • ISO 14001 Environmental Management System
        • ISO 45001 Occupational Health and Safety Management System
        • IATF 16949 International Automotive Task Force
        • ISO/IEC 17025 Testing and Calibration Laboratories
        • ISO 13485 Quality Management for Medical Devices
        • AS 9100 Quality Management System for Aerospace Industry
        • ISO 20000 IT Service Management
        • ISO 22301 Business Continuity Management
        • ISO 31000 Risk Management
        • ISO 37001 Anti-Bribery Management System
        • ISO 55000 Asset Management
        • TL 9000 The Telecom Quality Management System
        • Food Safety Management System
        • Integrated Management System (IMS)
      • The Malaysian Standard for Sustainable Palm Oil Production (MSPO) >
        • General Differences between MSPO and RSPO
        • Deadlines for MSPO Certification
        • MSPO Certification Process
        • Photo Gallery
      • Business Continuity Management >
        • How We Can Assist You
      • Halal Certification >
        • Certification Scheme
      • Safety and Health Officer Support
  • Training Courses
    • Soft Skills >
      • Leadership & Supervision Skills
      • Motivation & Teambuilding
      • Communication & Interpersonal Skills
      • Presentation & Public Speaking Skills
      • Clerical & Administrative Skills
      • Customer Relationship Management Skills
      • Negotiation Skills
      • Sales & Marketing
      • Creative Thinking & Problem Solving
      • Human Resource
      • Microsoft Office
    • Business Management >
      • Purchasing & Logistic
      • Supply Chain Management
      • Process Improvement & Core Tools
      • Responsible Business Alliance (RBA) and Sedex Members Ethical Trade Audit (SMETA)
      • Lean & Six Sigma
      • Electrical & Electronics
      • Project Management
      • Industry 4.0
    • Manufacturing Operations >
      • ISO 50001 Energy Management System / Energy System
      • ISO 9001 Quality Management System
      • ISO 14001 Environmental Management System
      • ISO 45001 Occupational Health and Safety Management System
      • ​IATF 16949:2016 International Automotive Task Force
      • ISO/IEC 17025 Testing and Calibration Laboratories
      • ISO 13485 Quality Management System for Medical Devices
      • AS 9100 Quality Management System for Aerospace Industry
      • ISO 22000 IT Service Management
      • ISO 22301 Business Continuity Management
      • ​ISO 31000 Risk Management
      • ​ISO 37001 Anti-Bribery Management System
      • ​ISO 55000 Asset Management
      • Food Safety Management System
      • TL 9000 Telecom Quality Management System
      • Integrated Management System
    • Health & Safety >
      • Occupational Health & Safety
      • First Aid
      • Fire Safety
      • Transportation Safety
    • Malaysian Standard for Sustainable Palm Oil Production (MSPO)
  • Events
    • Remote Online Training
    • Public Training in Johor Bahru
    • Public Training in Kuala Lumpur
    • Online Registration
  • External Info
    • Human Resource
    • Environment
    • Health & Safety
  • Contact Us
    • Career Opportunities