Curt Gendler

Senior Quality Engineer, AstraZeneca Biologics

Curt is a senior validation and IT professional with over 30 years technical, managerial and compliance experience participating in/supporting all aspects of validation concentrating in the medical device and bio-pharmaceutical industries; working for industry leaders such as J&J / McNeil Consumer, Alcon/Novartis, Genzyme/Sanofi, Livingston Healthcare Services/UPS, Fujisawa Healthcare & Pilling Surgical/Teledyne. He is a recognized SME on 21 CFR Part 11, Part 820 (where applicable to the process of validation), knowledge of Annex 11, the process of computer system network/infrastructure validation. I have a keen ability to adapt to new systems and processes. Have assessed & remediated data integrity vulnerabilities, been involved in contributing to and participating in ISPE’s JETT® consortium (redefining validation templates for GAMP/ISPE), presented at various CSV conferences, IVT’s Qualifying and Validating Cloud Computing, presented at Philadelphia ASQ chapter on Data Integrity and Data Governance & co-founder of an international users group of Statistical Process Control software. The American Society for Quality has qualified me as an instructor for the Certified Software Quality Engineer course.

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