Course Description:
This course will cover the main aspects USP General Chapter <1079> Supply Chain Risks and Mitigation Strategies on the Storage and Transport of Finished Drug Products and <1083> Supplier Qualification. The content will consist of good practices approach, as well as risk and mitigation strategies for storage and transportation of a finished drug product. A quality risk-based approach will be discussed on how to select, assess, approve, and monitor suppliers of ingredients, packaging materials, and other components and services.
Upon completion of this course, you will be able to:
- Explain the concept and the main risks of a supply chain
- Describe the main mitigation strategies for risks in storage and distribution
- Discuss how to build a quality management system based on risks and their mitigation strategies.
- Summarize approaches that can be used to keep materials or products within required labeled specifications.
- Describe the key points for temperature excursion handling and temperature mapping.
- Identify the main steps in the supplier qualification life cycle.
- Explain the audit process used for compliance with good distribution practices.
- Build an aid-memoire to audit suppliers.
Who Should Participate:
- Analytical Scientists
- QC/QA Analysts
- Manufacturing scientists and managers
- Regulators and regulatory affairs specialists
- Contract manufacturing organizations
- Distributors
- Freight Forwarders
The live version of this recording took place on June 7 - 8, 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
Glaucia Karime Braga, Ph.D.
USP Affiliation: Packaging & Distribution Expert Committee Member Co-Chair, Chair of the Supplier Qualification Joint Subcommittee
Title: QA Auditor/Associate Professor
Education: Ph.D., M.Sc. and B.Sc. Pharmaceutical Sciences, B.Sc. Education