Advanced Batch Production Records Concepts

Advanced Batch Production Records Concepts

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.

Audience

  • Biomanufacturing
  • Bioprocessing
  • Pharmaceutical
  • Medical Device
  • Cosmetics
  • Other FDA regulated industry sectors

Topics Include

  • 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

Learning Objectives

  • 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
Advanced Batch Production Records Concepts

Request this Course

Level: Intermediate

Lecture HoursLab or Activity HoursTotal

Delivery Options

Face-to-Face
Delivered in-person in a classroom or lab setting.
Hybrid
A combination of online and in-person components.
Live Instructor Led
Delivered online with a live instructor at a scheduled date and time.
Related
Basic Technical Writing
Course
Students will learn how to write using the three most commonly needed skills in any type of... more
Quality Risk Management
Course
Quality Risk Management is utilized by companies to determine where the risks lie that may... more
BioWork: Process Technician
Course
The BioWork certificate program will teach you the foundational skills you need to begin a career... more
Allergen Refresher for Food Manufacturing
Course
Does your facility produce products with multiple types of allergens? 30% of all recalls stem from... more
  •  
  • 1 of 7
  • >