Participants will learn the importance and benefits of having and completing Batch Production Records (BPRs) and the differences/similarities/relationship to the Master Batch Records. They will also learn how and why to effectively review batch production records for accuracy and completeness for compliance with Good Documentation Practices and for Data Integrity. Participants will explore manual and digital BPRs, determine what items are included in these, and the steps that are necessary to effectively review them before reviewing an actual, internal BPR for errors, omissions, and completeness.
- Biomanufacturing
- Bioprocessing
- Pharmaceutical
- Medical Device
- Cosmetics
- Other FDA regulated industry sectors
- Benefits of Effective BPRs
- Regulatory Requirements for BPRs
- Master Batch Records
- Relationship of BPRs and MBRs
- Content of BPRs
- Effective Reviews of BPRs
- Actual Review Activity of a BPR
- Discuss the rationale for why we complete batch production records (BPRs)
- Understand the relationship between BPRs and current Good Manufacturing Practices compliance
- Examine regulatory aspects of BPRs
- Review the basics of Master Production Records and BPRs
- Explore examples of information included in BPRs
- Compile a list of items for completing a BPR internally
- Compile a list of objectives for reviewing a BPR internally
- Examine an internal BPR for errors and discussion
Delivered in-person in a classroom or lab setting.
A combination of online and in-person components.
Delivered online with a live instructor at a scheduled date and time.
Intermediate
