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The publication of ISO 13485:2016 marks a turning point in Quality Management Systems for those involved in the lifecycles of medical devices. Organisations presently complying with ISO 13485:2003 now have until March 2019 to comply with this new revision, with its increased requirements around risk management and documentation.
This essential 5 module course will allow you to get a head start on your transition plans and become familiar with ISO 13485:2016.
Suitability - Who should attend?
This course will be useful for anyone considering the application of ISO 13485:2016, or who needs an overview of Quality Management Systems for medical devices. It will be applicable for professions in:
- Product design
- Regulatory affairs
Training Course Content
• Understand the documentation structure required by the standard
• Investigate best practice for document control
• Examine management responsibility and resource management requirements
• Explore product realisation from the design process to manufacturing
• Understand validation of aspects of the manufacturing process
• Comprehend business monitoring
• Gather and analyse data using internal audits and corrective action processes
£640 + 20% VAT = £768
PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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