Good Manufacturing Practice for Medical Devices
Training
In Reading
Description
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Type
Training
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Level
Intermediate
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Location
Reading
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Duration
1 Day
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Start date
Different dates available
This interactive Good Manufacturing Practice (GMP) training course covers the requirements of the Medical Device Regulatory Standard ISO 13485 and the regulatory framework and documentation required to market a medical device.
Those attending will get an understanding of the requirements and documentation required to market and maintain compliance for medical devices in the market place. There are tutorials on the Directives, the regulatory system, the marketing of a device and the ISO 13485 Medical Device Standard. Added to this there is an introduction to risk management and the vigilance system.
Facilities
Location
Start date
Start date
Reviews
Subjects
- Compliance
- Quality Training
- Medical Device
- Pharmaceutical manufacturing
- Regulatory Compliance
- GMP
- Manufacturing Process
- Quality Process
- Quality Testing
- Audit
Teachers and trainers (1)
Lisa Banwell
Quality and Regulatory Consultant
Course programme
Course Overview
This interactive Good Manufacturing Practice (GMP) training course covers the requirements of the Medical Device Regulatory Standard ISO 13485 and the regulatory framework and documentation required to market a medical device.
Those attending will get an understanding of the requirements and documentation required to market and maintain compliance for medical devices in the market place. There are tutorials on the Directives, the regulatory system, the marketing of a device and the ISO 13485 Medical Device Standard. Added to this there is an introduction to risk management and the vigilance system.
Suitability
GMP for medical devices is the perfect course for people who are new to the medical device industry, the diagnostics sector or those working in the pharmaceutical industry where medical device regulations are applied - e.g. for inhalers, pre-filled syringes, infusion bags etc.
Learning Outcomes
At the end of the course you will:
- Understand the regulatory framework of medical device manufacture and marketing
- Understand the ISO standards and how they are used in the approval process
- Have knowledge of the tools used in risk assessment and vigilance systems
Additional information
Good Manufacturing Practice for Medical Devices