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

MMD-106    Validation Process Training for Medical Device

  • Overview
  • Course Objectives
  • Course Content
  • For Whom
  • Schedule and Hours
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>
So as to ensure a process consistently produces a result or product meeting predefined specifications associated with the manufacturers claims on safety & effectiveness of its medical device(s), process validation is conducted as a means of structured approach as well as objective evidence to meet ISO 13485, US FDA’s cGMP and corresponding regulatory requirements.

Participants will be led by an experienced process validation practitioner. Participants will be able to determine which processes require validation as well as how prepare validation master plans, protocols & reports and how to conduct deviation management.
  • Understanding of Process Validation requirements
  • Understanding the methodology of validation processes
  • Understanding the reference documents
  • Identification of validation report.
  • Requirements for Validation Protocols. 
  • Usage of GHTF’s Guidance on Process Validation. 
  • Qualification Protocols - IQ, OQ, and PQ. 
  • Sampling techniques & sample size selection. 
  • Statistical sampling – methods, rationale and justifications. 
  • Documenting the results and reporting conclusions. 
  • Process Revalidation – know what the real expectations are. 
  • Avoiding pitfalls and non-complying process validation practices
Those whom contribute towards ensuring the medical device meet regulatory requirements for risk management as well as those whom conduct change management, including:
  • Regulatory/quality systems professionals 
  • Manufacturing engineers 
  • Process development engineers 
  • Those involved in validating processes 
  • Internal & Supply Chain Auditors
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