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TRANSCRIPT
Two days State level seminar at Smt. Kashibai Navale College of Pharmacy on
“QA, QC and Regulatory Affairs in Pharmaceutical Industry” on 2nd & 3
rd Feb 2018
Sinhgad Technical Education Society’s Smt. Kashibai Navale College of Pharmacy (SKNCOP) Pune -
411048, Maharashtra organized Two days State level seminar on “QA, QC and Regulatory Affairs in
Pharmaceutical Industry” on 2nd & 3rd Feb 2018 sponsored by Savitribai Phule Pune University.
First Day began with inauguration at the hands of chief guest Dr. Manohar Potdar President
(Technical) Doshi Pharmaceutical Consultants, Indore, (M.P) & Prof. Shyam Khante, President
Shyam Khante & Associates. It was followed by welcome address by Principal Dr. S. D. Sawant,
Chief Convener and preamble by Ms. Manjusha Dole, Convener for the seminar.
Plenary sessions began with Key Note address by Dr. Manohar Potdar. He also spoke on
Pharmaceutical Facility Audits: Concepts & Practices” .This was followed by session on
“Culture of quality for regaining credibility in the global pharmaceutical market”, by Prof. Shyam
Khante, President Shyam Khante & Associates.
In the afternoon session Dr. Sathiyanarayanan L., Associate Professor & Head, Center for Food
Testing Laboratory, BVDU, Poona College of Pharmacy spoke on “Application of Quality Control
Principles to drugs & herbal medicines”.This was followed by a session on“GMP Compliance” by
Mr. Atul Shirgaonkar, Director Insight Professional Management Academy, and a session on “Quality
Assurance of Biopharmaceuticals” by Mr. Shailesh Darakh, Senior Manager QA, Gennova
Biopharmaceuticals Ltd.
Second day the sessions included “Comparative Study Between Schedule M vs WHO GMP” by Mr. S.
R. Chunekar, Additional Director QA, Serum Institute of India Pvt. Ltd & “Good Manufacturing
Practices Quality Assurance Regulation” by Mr. Nilesh Kalpande, Sr. Research Scientist, Lupin
Limited.
Afternoon session on second day began with talk on “Data Integrity – Role of Quality Assurance” by
Dr. Subhash Gore, Vice President, R & D, Lupin Limited, &“Regulatory Requirement for US & UK
market” by Dr. Pravin Kamble, Head Patent Department Abbott Healthcare Pvt. Ltd, Mumbai. The
programme concluded with valedictory function summarized by Ms. Tejal Katke.
Savitribai Phule Pune University sponsored
Two days State level Seminar on
“QA QC and Regulatory Affairs in Pharmaceutical Industry”
[2nd
& 3rd
Feb 2018] Organized by
Sinhgad Technical Education Society’s,
Smt. Kashibai Navale College of Pharmacy, Kondhwa (Bk), Pune-48.
Sr.
No
Speaker Organisation Topic
Day 1- Friday, 2nd Feb 2018
1
Dr. Manohar Potdar
President (Technical)
Doshi Pharmaceutical Consultants
Indore, (M.P)
9860165813
“ Pharmaceutical Facility
Audits: Concepts &
Practices”
2
Prof. Shyam Khante
President Shyam Khante & Associates
7774059085
“Culture of quality for
regaining credibility in the
global pharmaceutical
market”
3
Dr. Sathiyanarayanan L
Associate Professor Head, Center for Food Testing Laboratory,
BVDU, Poona College of Pharmacy
0937185066
“Application of Quality
Control Principles to drugs
& herbal medicines”
4
Mr. Atul Shirgaonkar Director Insight Professional Management
Academy
9822033002
“GMP Compliance”
5
Mr. Shailesh Darakh
Senior Manager QA
Gennova Biopharmaceuticals Ltd Pune
Contact No - 9689927761, 9834190998
“Quality Assurance of
Biopharmaceuticals”
Day 2- Saturday, 3rd Feb 2018
6
Mr. S. R. Chunekar
Additional Director QA
Serum Institute of India Pvt. Ltd
9420176935
“Shortfalls in the Indian
regulatory system vis a vis
the global regulatory
bodies”
7
Mr. Nilesh Kalpande
Sr. Research Scientist Lupin Limited
9922432187 [email protected]
“Good Manufacturing
Practices Quality Assurance Regulation”
8
Dr. Subhash Gore
Vice President, R & D
Lupin Limited
8554999084
“Data Integrity – Role of
Quality Assurance”
9
Dr. Pravin Kamble
Head Patent Department
Abbott Healthcare Pvt. Ltd., Mumbai
9769954749
“Regulatory Requirement
for US & UK market”
