Course Description:This course will cover the main aspects related to the control of impurities in drugs and medicines and the application of the USP –NF General Chapter <1086> Impurities and Forced Degradation Studies. The content will consist of forced degradation studies that assist in the identification of the most likely degradation products. Case studies will demonstrate degradation pathways, intrinsic stability of the molecule and validation of the analytical procedures.
Upon completion of this course, you will be able to
- Compare regulatory versus development guidance
- Explain regulatory guidance for impurities
- Describe the fundamentals of oxidative degradation
- Identify and apply best practices for oxidative stress testing
- Describe the fundamentals of photochemistry
- Identify and apply best practices for photostability testing.
- Explain the importance of stress testing conditions
- Identify forced degradation data in regulatory filings
- Explain considerations for applying ICH M7 guidance to product development
- Apply ICH and regulatory guidance to case studies
Who Should Participate:
- Research and Development
- QA/QC Staff
- Regulatory Affairs Specialists
The live version of this recording took place on November 14-15, 2023.
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
The accompanying USP General Chapter(s) available as resources with this course, were official as of the date indicated in the chapter PDF. Please check www.uspnf.com for relevant updates.
USP Approved Instructor
Dr. Ravi Reddy
Senior Director of Reference Standards Development (RSD) at USP
Ph.D. in chemistry from the Indian Institute of Technology, India