Course Description:
USP General Chapter <1037> Process Analytical Technology – Theory and Practice has been published in USP’s Pharmacopeial Forum for public comments.
The objective is to establish a comprehensive guide that aligns with current scientific and regulatory standards, providing clear direction for the
implementation of Process Analytical Technology (PAT) within pharmaceutical companies. This chapter serves as a comprehensive guidance on PAT, ensuring
the continued advancement and quality of pharmaceutical manufacturing. The new chapter on PAT will contain but not be limited to the following topics:
Introduce newly proposed PAT chapter <1037> Process Analytical Technology – Theory and Practice: Prospectus
PAT definition and its core attributes
Enablers I: Instrumentation and chemometrics in PAT
Enablers II: Life cycle management of PAT
Enablers III: An overview of the regulatory landscape
Use Cases: Emerging trends and technologies in PAT
In addition to Chapter <1037>, two Stimuli articles - one on Theory of Sampling in PAT and the other on Implementation of Real Time Release Testing - will also be discussed. This webinar will further introduce other related PAT initiatives at USP, including the USP Pharmaceutical Continuous Manufacturing Technical Guidance, an Overview of the USP Advanced Manufacturing Technology Laboratory, and USP Pharmaceutical Continuous Manufacturing
Knowledge Hub.
Who should participate:
- Compendial Liaison
- Consultant
- Engineering/Manufacturing
- Executive
- QA Manager
- QA staff
- QC Chemist
- QC Manager
- R&D
- Regulatory
Access Duration:
Access to this course expires 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.