Show e-learning-courses.co.uk as: Mobile

Understanding ISO 13485:2016

PTI
Course summary
5 weeks
640 GBP excl. VAT
English
Distance
Next available date: 04/11/2019 09:00 - Distance
e-learning / Online / Distance

Course description

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:

  • Quality
  • Engineering
  • 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

Expenses

£640 + 20% VAT = £768

About provider

PTI


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,...


Read more and show all courses with this provider

Request info

Fill out your details to find out more about Understanding ISO 13485:2016.

  Contact the provider

  Get more information

  Register your interest

Contact info

PTI

London

 Show phone number
www.pti-global.co.uk

Request Information

Find out more about this Understanding ISO 13485:2016 course - simply fill out your details: