Course Overview

This course is designed to equip participants with the foundational knowledge and skills required for excellence in the field of medical manufacturing. It covers regulatory frameworks, quality assurance, manufacturing technologies, and best practices in the production of medical devices and equipment.

Target Audience

• Experienced professionals seeking to update their knowledge
• Quality assurance and regulatory affairs personnel
• R&D professionals transitioning to manufacturing roles

Course Duration

• Total: 40 hours (5 days)
• Daily sessions: 8 hours

Delivery Method

• In-person, facilitated workshops
• Hands-on laboratory sessions
• Online learning modules for pre-course and post-course reinforcement

Course Modules

Module 1: Introduction to Medical Manufacturing

• Overview of the medical device industry
• Key concepts and terminology
• Regulatory environment (focus on FDA, EMA, and ISO standards)

Module 2: Regulatory Compliance and Quality Management

• Detailed overview of relevant regulations (e.g., ISO 13485, FDA QSR)
• Implementing quality management systems (QMS)
• Documentation and record-keeping essentials

Module 3: Manufacturing Processes and Technologies

• Common manufacturing processes for medical devices
• Introduction to cleanroom standards and operations
• Advances in manufacturing technology (e.g., 3D printing, robotics)

Module 4: Product Development and Design Controls

• Steps in medical device product development
• Design controls and their importance in manufacturing
• Risk management in design and production

Module 5: Quality Assurance and Control

• Principles of quality assurance (QA) and quality control (QC)
• Inspection and testing methodologies
• Handling non-conformances and CAPA (Corrective and Preventive Actions)

Module 6: Supply Chain Management

• Basics of supply chain management in medical manufacturing
• Vendor selection and management
• Ensuring supply chain integrity and compliance

Module 7: Ethical Manufacturing Practices

• Ethical considerations in medical device manufacturing
• Environmental and sustainability practices
• Social responsibility in the manufacturing sector

Learning Outcomes

Upon completion of this course, participants will be able to:

• Understand the regulatory environment and quality management systems applicable to medical manufacturing.
• Identify and apply key manufacturing processes and technologies.
• Implement effective quality assurance and control measures.
• Navigate product development with a clear understanding of design controls and risk management.
• Manage supply chain aspects with an emphasis on compliance and ethics.