Mr. Thakker is a visionary with hands-on expertise that spans 30 years in CGMP / Cell Therapy Quality Systems, CSV (Computerized System Validation), ERES (Electronic Record/Electronic Signature), Data Integrity, and regulatory compliance.
Throughout his career, he has continuously refined his ability to interpret, simplify, and implement the US FDA CGMP regulatory requirements effectively. He believes in simplifying processes to reduce time, effort, and compliance costs.
Serving as a Global CSV, CGMP, and Cell Gene Therapy Process and Apheresis Auditor, he has conducted nearly 200 audits worldwide. He has played a pivotal role in regulatory compliance by overseeing health authority inspections, conducting mock inspections, and designing global quality systems.
As a global speaker, he has contributed to compliance awareness through speaking engagements on topics like Inspection Readiness, Training, and Validation. His contributions to industry guidance include leadership in the development of the GAMP-based "Risk Based Commissioning and Qualification" chapter 11 for the 2009 ISPE Baseline Guideline.
His key strengths lie in leadership, team building, and commitment to supporting team members. As a subject matter expert and mentor, he possesses a deep understanding of global regulatory requirements, including US FDA 21CFR, EU regulations, and many other international regulatory requirements.
In 2009, he founded a company and experimented with a next-generation single computer system validation solution, which evolved into the OC11 Word SaaS cloud platform. This platform integrates logical global GxP, data integrity algorithms, artificial intelligence, and a single computer system validation solution.
His vision is to provide an affordable easy to use computerized solution to manage extremely complex pharmaceutical, biotech, medical device, blood bank, and cell therapy global regulatory compliance to a single testing laboratory to a large global GxP (Pharmaceutical Drug, Cell Therapy, clinical, etc.) operations with multiple sites.
