Esra Guven

Manager, Computer Systems Validation, Global Information Services, Apotex Inc. 

Ms. Guven has over 20 years of experience in IT Quality and Computer Systems Validation in Pharmaceutical Industry, including:

  • Over 10 years of supervisory, leading, and mentoring experience
  • Over 10 years of Process / Continuous Improvement experience
  • Superior knowledge on FDA 21 CFR Part 11 Electronic Records and Electronic Signatures and Data integrity remediation
  • Project Management Institute (PMI) Project Management Professional (PMP) certified
  • American Society of Quality (ASQ) – Certified Six Sigma Green Belt
  • Certified Trainer
  • Certified Lead Investigator
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