Course Description:
This course provides an understanding of USP General Chapter <1221>, focusing on the principles and application of Ongoing Procedure Performance Verification (OPPV). Participants will learn how to ensure the reliable performance of analytical procedures during routine use by confirming their ability to consistently meet the requirements defined in the Analytical Target Profile (ATP) and deliver fit-for-purpose reportable results.
Through proactive monitoring of performance-related data and trends, the course emphasizes identifying potential issues early, implementing timely corrective actions, and prioritizing continuous improvement. By the end of the course, participants will be equipped with practical strategies to maintain analytical integrity and support robust quality systems.
Upon completion of this course, you will be able to:
- Verify that analytical procedures perform as expected, meet the Analytical Target Profile (ATP) or Critical Quality Attribute (CQA) requirements, and are fit for purpose.
- Collect and analyze performance data systematically to detect issues or adverse trends, enabling timely corrective actions and continuous improvement.
- Define and apply appropriate performance metrics for ongoing monitoring of analytical procedures.
- Identify and classify levels of precision to support reliable performance assessment.
- Develop and utilize control charts to monitor procedure performance effectively.
- Assess risk associated with decisions based on results generated by analytical procedures.
Who Should Participate:
Note: Participants taking this course must have 2-3 years experience in pharmaceutical analytics and/or quality control. It is highly recommended that participants complete eLearning: Analytical Procedure Life Cycle and Application of the AQbD Approach (CM-1220-01) prior to attending this course (CM-1221-01).
- Compendial Liaison
- QA manager
- QA staff
- QC chemist
- QC manager
- R&D
- Regulator
- Production Personnel