Friday, 22nd October 2021
13:30 |
Test Run and Web Checks
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14:30 |
Inauguration and Introduction to the Experts
Sanjay Bajaj, CEO & MD, Glostem Private Limited, India
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14:45 |
Welcome Address
Saranjit Singh, Professor & Head, NIPER Mohali
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14:55 |
Identifying OOS & OOT Test Results and CQA Risk Assessment
Vipul Dholakia, Former Senior Policy Advisor and Consumer Safety Officer, FDA, USA
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15:15 |
Open Discussion
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15:30 |
OOS Investigations-Critical Factors in Designing and Conducting
B M Rao, Vice President & Head - EMQA, CQC & ASAT, Dr Reddy’s Laboratories, India
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15:50 |
Open Discussion
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16:05 |
Minimizing OOS/OOT Results in an Analytical Laboratory
Jane Weitzel, Pharmaceutical Consultant, Independent Consultants, Canada
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16:25 |
Open Discussion
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16:40 |
OOS/OOT Invesitgations - Overcoming Challenges: A Case Studies
Bhaskar Kolte, Associate Director - Analytical Research Development, Perrigo, India
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17:00 |
Open Discussion/Rap Session
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17:25 |
Closing Remarks
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17:30 |
End of the meeting
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