This course presents the overview of how medical devices are regulated in international markets, particularly with connection to EU MDR, 21 CFR Part 820, and ISO 13485. It considers relevant concepts that underpin how the term GMP ought to be understood. Differences between regulations, standards, and guidance documents are acknowledged. In addition, focus of GMP compliance and specific approach to compliance are discussed. From the global regulatory environment, the learners are then led into a more focused landscape to understand the essentials of GMP in a device manufacturing environment, such as personnel, premises, processing, etc.
- The global regulatory environment
- Describe the regulatory obligations as a GMP manufacturer.
- Understand the historical development of medical device regulations.
- Appreciate the differences in medical device regulation across international markets with connection to EU MDR, ISO 13485, and 21 CFR Part 820
- State the difference between regulations, standards, and guidance documents.
- State the fundamental focus and approach for GMP compliance.
- The essentials of GMP in a device manufacturing environment
- Personnel and Training
- Premise/Facility Control
- Production Areas
- Storage Areas
- Quality Control Areas
- Ancillary Areas and supporting systems
- Workplace Cleanliness and Contamination Control
- Material Control
This course has been designed to provide personnel new to the medical device industry with a fundamental understanding of regulatory requirements related to EU MDR, 21 CFR Part 820, and ISO 13485. It also applies to experienced GMP staff looking for a refresher, or existing companies that require a new GMP licence or GMP certificate from the regulatory bodies.
Format and Course Length
The 1-day course involves a lively mix of case studies / workshops and tutorial sessions. The delivery method is collaborative involving a small group and facilitator, which has been shown to enhance effective learning and critical thinking skills of participants. You will receive PDF copies of the training material and a Certificate of Attendance.
Singapore, February 2020.
Dates can be flexible and we encourage you to contact us with your needs so we can discuss how to help.