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Details

So as to ensure a process consistently produces a result or product meeting predefined specifications associated with the manufacturers claims on safety & effectiveness of its medical device(s), process validation is conducted as a means of structured approach as well as objective evidence to meet ISO 13485, US FDA’s cGMP and corresponding regulatory requirements.

Participants will be led by an experienced process validation practitioner. Participants will be able to determine which processes require validation as well as how prepare validation master plans, protocols & reports and how to conduct deviation management.

Outline

  • Requirements for Validation Protocols. 
  • Usage of GHTF’s Guidance on Process Validation. 
  • Qualification Protocols - IQ, OQ, and PQ. 
  • Sampling techniques & sample size selection. 
  • Statistical sampling – methods, rationale and justifications. 
  • Documenting the results and reporting conclusions. 
  • Process Revalidation – know what the real expectations are. 
  • Avoiding pitfalls and non-complying process validation practices
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Ampro believes that the key to a successful and rewarding career is continuous professional development.  We have a flexible approach to your training needs with regardless of whatever your requirements, we promise you a high level of service with packages that meet the needs of your business.

As a forward thinking company we deliver training at all levels, thereby supporting your company at every stage of its development. Courses can be delivered onsite at a location of your choice, costs dependent upon location and numbers, or at hotel.

Our Company Values
We are determined in developing new programmes and staying on-point with industry's trend, while maintaining exceptional quality standards.

When we commit to something, we’re totally devoted. Whether it’s our dedication to our clients; or to maintain at the leading edge of training services we offer; we are always dedicated to our task.

Our People
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are highly motivated professionals, experienced and qualified in their own specialist areas, who are committed to works towards common goals.

Our trainers and consultants are quality assure and have been tested on their ability to deliver top-quality programmes. ...
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