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