QbD International Brief In a career span of 49 years, have rich & varied experience in the Pharma Industry, especially in Quality Management, R&D, Mfg.-US FDA / EU / WHO etc. compliances. Conferred “100 Most Impactful Healthcare Leaders -Global” Award by World Health Congress. Currently: Quality Expert Consultant- MPP Geneva (United Nations) Member of Editorial Board of Journal of Generic Medicines – England. Quality by Design / CGMP / Regulatory Consultant. Expert on Quality by Design / Data Integrity / CAPA / Quality Culture & various other CGMP subjects. Expert Auditor of “Formulations” & “API” facilities / CRO 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. Worked with PFIZER LTD./ Sun Pharma(Ranbaxy) / Lyka Labs, Cancer Research Institute Mumbai. Retired as “Global Quality Head / Vice President” in 2006. Exposed to many International Regulatory Inspections US FDA, EU, WHO, MHRA, ANVISA, TGA, Canada, South Africa, Egypt, Japan, etc. for finished dosage forms / API Mfg. Supporting many API / Drug Products organizations for US FDA / EU / MHRA WHO etc. for Audit ready preparations. Travelled extensively across the Globe as Chairman & or Speaker at various International conferences. So far 441 presentations given in 70 countries on: “ cGMP, QbD, PAT, US FDA/EU Inspections, GCP/ GLP, 21 CFR part 11, Technology Transfer, Operational Excellence , ISO, ICH, Risk Management , Regulations, Vendor development /outsourcing etc.” at various International conferences 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. Have articles / interviews, published in various International Journals like Pharmaceutical Manufacturing-USA, Pharmaceutical Technology-Europe, and Pharmaceutical Technology-Asia, Digital version to mention few. 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).