Manufacturing Process Validation for Medical Devices

Course Title:

Manufacturing Process Validation for Medical Devices

TERMINAL OBJECTIVES

By the end of the training, participants will be able to:

1. Understand the regulatory requirements for manufacturing process validation in the medical device industry.
2. Be capable of planning and executing process validation activities in line with international standards (ISO 13485, FDA QSR).
3. Ensure compliance with validation protocols to enhance the effectiveness of manufacturing processes.

SESSION OBJECTIVES

At the end of the presentation participants should be able to do the following:

1. Explain the principles of process validation.
2. Describe different types of process validations: IQ, OQ, PQ.
3. Develop a validation protocol and report.
4. Apply risk-based approaches in manufacturing process validation.

Course Outline

1. Introduction to Manufacturing Process Validation for Medical Devices

• Ice breaker – “Recognizing and Identifying the important of Manufacturing Process Validation for Medical Devices”
• Objectives of workshop
• Agenda
• Administrative arrangement

2. Manufacturing Process Validation for Medical Devices Review

• Introduction of Manufacturing Process Validation for Medical Devices
• Overview of Manufacturing Process Validation for Medical Devices
• Briefing on each clause of Manufacturing Process Validation for Medical Devices

Training Methodology: 

1. Workshop / Hands-On Practical Session

• Participants develop group workshop
• Interactive session: Identify typical nonconformities in an audit case study

2. Course Assessment & Certification (1 hour)

• Quiz / Knowledge Assessment (MCQs, Open-ended Questions)
• Practical exercise: Evaluate a sample training matrix for effectiveness
• Certificates issued for successful participants

Course Deliverables: 

 Training Material (Slides & Handouts)

Certificate of Completion

 

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