Brief
In a career span of 52 years, have rich & varied experience in the Pharma Industry, especially in Quality Management, R&D, Mfg., Regulatory, US FDA / EU / WHO etc. compliances.

Major Awards:
“Quality Champion – Gold” Topmost Quality Award by Govt. of India – Quality Council of India.
“Lifetime Achievement” Award by International UNICEF Council- USA”.
“100 Most Impactful Healthcare Leaders -Global” Award by World Health Congress / ET. Etc. Invited as “Jury” by Economic Times for ET Healthcare Awards 2022.

Currently:
CEO- QbD International (Quality by Design / CGMP Consulting — Bio-Pharma / Pharma).
United Nations- MPP Geneva Advisor.
Member of Editorial Board of Journal of Generic Medicines – England.

Expert on Artificial Intelligence – Pharma 4.0, ML, DL, Quality Data, Automations Applications, Quality by Design / Data Integrity / CAPA / Quality Culture, Validations, Continuous Mfg. PAT, Regulatory, & various other CGMP subjects. Expert Auditor of “Formulations” & “API” facilities etc. Worked as Quality Expert with World Bank- Washington USA. Worked with Saudi Arabia FDA for generating the regulations and training SFDA inspectors on behalf of World Bank.

Compliance Audits – Inspections: Literally conducted 100’s of audits / inspections in 52 years, at various Cos. in India / Saudi Arabia / Oman / China / USA / EU / Brazil / Mexico / Malaysia / Chile etc.: of Formulations sites (Sterile / Non Sterile), API sites, Outsourcing Labs, CROs.

Travelled Globally to 70 countries & delivered 521 presentations in Conferences, as Chairman or Keynote Speaker or Speaker, organized by ISPE FDA, Marcus-Evans, IQPC, IPC, CBI ( USA) , WHO, ISO, UNOPS, Govt. of India, CPHI , FDA of Gujarat, Maharashtra, FDA – AP, FDA – Karnataka etc.

Addressed 131 Webinars / Live talks till date in last 36 months on Covid19 & various Pharma subjects.
Have articles / interviews, published in various International Journals like Pharmaceutical Manufacturing-USA, Pharmaceutical Technology-Europe, and Pharmaceutical Technology-Asia, Pharma -Express, ResearchGate, WHO to mention few.

Educational Engagement and Mentorship
Advisory Board member for distinguished Pharmacy Colleges including DYPatil University Pharmacy College-Nerul & Pune, NM Sattha College of Pharmacy, Geetanjali University-Udaipur. Was nominated as an IPA expert Geneva, for new “ICH Expert working Group-Geneva, on CTD QOS”. Served as member of IPA, IDMA, ISPE, Gujarat council of Bio-Technology etc. Worked also as a faculty member of OPPI, IDMA, ISO workshops & was member of “GMP committee for API” by DCGI (Govt. of India).

Worked with PFIZER LTD./ Sun Pharma (Ranbaxy) / Lyka Labs, Cancer Research Institute Mumbai. Retired as “Global Quality Head” in 2006.