MMD-128    Production Part Approval Process (PPAP) Awareness and Submission
                      Requirements - Medical Device Manufacturing

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

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The Production Part Approval Process (PPAP) is a structured part and process approval methodology used in medical device manufacturing to demonstrate that production parts, processes, and supporting evidence consistently meet customer and regulatory design and specification requirements before regular supply. This 1-day programme provides a practical overview of PPAP requirements as applied in the medical device and medical product manufacturing context, including linkage to quality management system requirements, design controls, process validation, and customer approval expectations and regulatory-aligned documentation requirements.
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The programme is designed for personnel involved in new product introduction, design transfer, engineering change, supplier qualification, production launch, customer submission, and PPAP review activities in medical device manufacturing environments. Participants will be guided through practical examples and discussion points covering PPAP purpose, submission triggers, submission levels, the 18 PPAP elements, production run expectations, Part Submission Warrant, customer approval status, record retention, and common submission weaknesses.

On completion of this training, participants will be able to:

• Understand the purpose, structure, and application of PPAP within medical device manufacturing environments.
• Explain PPAP submission requirements, submission levels, and circumstances requiring initial submission or resubmission.
• Identify and interpret the 18 PPAP elements and the supporting documentation required for customer approval.
• Relate PPAP requirements to ISO 13485, design controls, process validation, supplier management, and regulatory expectations.
• Prepare, review, and support PPAP submissions effectively while avoiding common documentation and approval deficiencies

• Module 1: Introduction to PPAP in Medical Device Manufacturing
• Module 2: PPAP Requirements and Submission Process 
  
• Module 3: Understanding the 18 PPAP Elements
  
• ​Module 4: PPAP Review, Approval, and Documentation Control
  

Quality engineers, quality managers, supplier quality engineers, manufacturing and process engineers, design transfer and NPI team members, production supervisors, document control personnel, purchasing and supplier development personnel, regulatory affairs personnel, internal auditors, and personnel involved in customer PPAP submission, PPAP review, or regulatory-aligned documentation support activities.

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.