The objective of this course is to provide the student with knowledge about Good Manufacturing Practices, to ensure that medical device manufacture is consistently controlled according to a set of quality standards. This course introduces the main characteristics of the medical device industry and why it is highly regulated.

Through case studies, students will learn how to ensure product quality and safety, comply with regulatory standards, and address challenges that professionals often encounter in the manufacturing industry.

At The End Of The Course You Will Be Able To

• Understand the regulatory framework of medical device manufacture.
• Have a general understanding of what Good Manufacturing Practices (GMPs) are and why they  are relevant for the Medical Devices Industry to ensure compliance to the quality system.
• Learn key concepts of GMP for the manufacture of medical devices, such as:
  • Personnel
  • Cleanliness and Hygiene
  • Productive Process
  • Documentation
  • Quality Assurance

• Understand the importance of maintaining a contaminant-free environment.
• Learn about quality and discuss how quality products are important for safety and efficacy.
• Understand the importance of GMP audits and how they can help companies to comply with guidelines set by regulatory authorities.

• Apply GMP requirements and gain knowledge to solve multiple real case situations throughout each class.

Course Content

1. GMPs Overview
2. What are Good Manufacturing Practices
3.  Key Elements in GMPs
   • Personnel
   • Cleanliness and Hygiene
   • Productive Process
   • Documentation
   • Quality Assurance