MMD-106    Validation Process Training for Medical Device

  • Overview
  • Course Objectives
  • Course Content
  • For Whom
  • Schedule and Hours
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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.
  • Understanding of Process Validation requirements
  • Understanding the methodology of validation processes
  • Understanding the reference documents
  • Identification of validation report.
  • 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
Those whom contribute towards ensuring the medical device meet regulatory requirements for risk management as well as those whom conduct change management, including:
  • Regulatory/quality systems professionals 
  • Manufacturing engineers 
  • Process development engineers 
  • Those involved in validating processes 
  • Internal & Supply Chain Auditors
This is a 2-days programme.
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This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.