OOS/OOT Investigations - Overcoming Challenges
  • Day1
Friday, 22nd October 2021

13:30

Test Run and Web Checks

14:30

Inauguration and Introduction to the Experts
Sanjay Bajaj, CEO & MD, Glostem Private Limited, India

14:45

Welcome Address
Saranjit Singh, Professor & Head, NIPER Mohali

14:55

Identifying OOS & OOT Test Results and CQA Risk Assessment
Vipul Dholakia, Former Senior Policy Advisor and Consumer Safety Officer, FDA, USA

15:15

Open Discussion

15:30

OOS Investigations-Critical Factors in Designing and Conducting
B M Rao, Vice President & Head - EMQA, CQC & ASAT, Dr Reddy’s Laboratories, India

15:50

Open Discussion

16:05

Minimizing OOS/OOT Results in an Analytical Laboratory
Jane Weitzel, Pharmaceutical Consultant, Independent Consultants, Canada

16:25

Open Discussion

16:40

OOS/OOT Invesitgations - Overcoming Challenges: A Case Studies
Bhaskar Kolte, Associate Director - Analytical Research Development, Perrigo, India

17:00

Open Discussion/Rap Session

17:25

Closing Remarks

17:30

End of the meeting

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