Certified Bio Medical Auditor

Course objectives

By the end of training in Certified Bio Medical Auditor, you will be able to:

Benefits for Individuals:

  • Analyze the effectiveness of a biomedical quality management system in relation to those national and international regulations.
  • Apply quality tools and process improvement techniques using qualitative and quantitative.
  • Appropriate standard driven data analysis and statistical techniques used for sampling.
  • Create an effective audit report, apply record retention requirements, and know when an audit can be closed.
  • Document observations, collect objective evidence, use working papers, and classify nonconformance.
  • Distinguish between audit procedural references and guidance’s (such as ISO 19011 and GHTF SG4) and the FDA Quality System Inspection Technique (QSIT).
  • Identify and apply standards related to risk management and hazard detection.
  • Identify and apply standards related to methods ofï sterilization for aseptically processed and terminally sterilized products.

 

Key features:

  • Instructor led Classroom Training
  • Copy of study materials
  • Internationally recognized course content.
  • Course Completion Certificate

 

Eligibility:

  • Biomedical/Pharmaceutical, Quality Manager, Medical Officers, Lab Technician, Pharmacist
  • Associate degree – one year waived
  • Bachelor’s degree – three years waived
  • Master’s or doctorate – four years waived