MMD-118    Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical
​                      Devices

• Overview
• Course Objectives
• Course Content
• For Whom
• Schedule and Hours

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This course provides a foundational understanding of ISO 11607, the globally recognized standard governing packaging for terminally sterilized medical devices. The standard defines the essential requirements for sterile barrier systems and packaging systems that ensure the safety, sterility, and performance of medical devices up to the point of use.
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The training will guide participants through key elements of ISO 11607 Parts 1 and 2, including material selection, design, validation, and ongoing process control. Real-world examples and regulatory expectations will be integrated throughout, giving participants a practical lens through which to evaluate compliance and quality assurance activities related to packaging systems.
Participants will be led by an experienced trainer who, in addition to being a medical device Regulatory & Quality Systems as well as a CE Marking auditor and product approval reviewer, has over 3 decades of assessment, training and quality assurance as well as management system development experience.

Upon completion this programme, participants are able to:

• Understand the structure and purpose of ISO 11607 Parts 1 & 2.
  
• Distinguish between sterile barrier systems and protective packaging.
  
• Identify key regulatory and quality system requirements related to packaging
• Understand validation and performance testing requirements for packaging systems.
  
• Recognize common nonconformities and prepare for audits effectively.
  

• Module 1: Overview of ISO 11607 Parts 1 & 2
• Module 2: Sterile Barrier Systems & Packaging Requirements
• Module 3: Validation & Performance Testing
• Module 4: Regulatory & Risk Management Requirements
• ​​Module 5: Common Nonconformities & Audit Findings

This course is ideal for personnel across all departments who are:

• Packaging engineering and development professionals
• Quality assurance and regulatory affairs personnel
• Medical device manufacturing and operations teams
• Validation, testing, and compliance professionals
• Internal auditors and those preparing for certification
• Personnel involved in ISO/IEC 17025 accreditation efforts

This is a ​1 day programme.
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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.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.