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GMP in Pharmaceutical Industry: Global cGMP and Regulatory Expectations

GMP in Pharmaceutical Industry: Global cGMP and Regulatory Expectations - Trupti Patil Dongare

GMP in Pharmaceutical Industry: Global cGMP and Regulatory Expectations

Dongare, Trupti Patil: - Trupti Patil-Dongare has over 14 years of experience in pharmaceutical industry in quality assurance, quality Control, regulatory compliance and production. I am Master in Industrial Pharmacy from Osmania University, Hyderabad, India and Advance Diploma in Pharmaceutical Quality Assurance Management from Institute of Pharmaceutical Education and Research Pune, Maharashtra, India. Versatile knowledge on all key functions of Non sterile API, Sterile API and formulation QA. Ample exposure to Regulatory affairs for filling the ANDAs, DMFs & Dossiers. Preparing, responding and committing to the regulatory bodies for deficiencies and queries. Knowledge on various national & international standards. Skilled in Quality Audits, Contract manufacturing, loan licensing sites (Sterile & non-sterile) & analytical testing sites.
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Dongare, Trupti Patil: - Trupti Patil-Dongare has over 14 years of experience in pharmaceutical industry in quality assurance, quality Control, regulatory compliance and production. I am Master in Industrial Pharmacy from Osmania University, Hyderabad, India and Advance Diploma in Pharmaceutical Quality Assurance Management from Institute of Pharmaceutical Education and Research Pune, Maharashtra, India. Versatile knowledge on all key functions of Non sterile API, Sterile API and formulation QA. Ample exposure to Regulatory affairs for filling the ANDAs, DMFs & Dossiers. Preparing, responding and committing to the regulatory bodies for deficiencies and queries. Knowledge on various national & international standards. Skilled in Quality Audits, Contract manufacturing, loan licensing sites (Sterile & non-sterile) & analytical testing sites.
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