Forced Degradation Studies - Requirements and Industry Practices
  • Day1
Friday, 14th October 2022

09:15

Forced degradation: regulatory perspectives, benefits and advancements
Saranjit Singh, Ex-Professor & Head, Pharmaceutical Analysis, NIPER, Mohali, India

11:15

Coffee break

11:30

Characterization of degradation products using sophisticated hyphenated techniques
Saranjit Singh, Ex-Professor & Head, Pharmaceutical Analysis, NIPER, Mohali, India

12:30

Q/A Session

12:45

Quantitation of degradation products, establishment of mass balance and dealing with practical challenges
BM Rao, Vice President, Dr Reddys Laboratories, India

13:45

Q/A Session

14:00

Lunch break

14:45

Forced degradation practices in industry, regulatory deficiencies around FD data and suggested solutions
BM Rao, Vice President, Dr Reddys Laboratories, India

15:45

Q/A Session

16:00

Coffee break

16:15

Open Session/Panel Discussion – Dr S Singh & Dr BM Rao

17:00

Closing remarks and end of the masterclass

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