🎤  Danielle DeLucy     |  📅  Recording Available   |  🕒  3 Hour


Lecture 1: Regulatory Requirements for GMP Documents – Batch Records and Beyond
  • Review Good documentation requirements for batch records
  • Types of Regulated documents and relative importance
  • Master Batch Record Templates – Control and Issuance
  • Manufacturing Records – In process and final product
  • Specifications – Quality Review
  • Investigations – Deviation and Out of Specifications
  • Change Control Process
Lecture 2: Methods for Batch Record Review
  • Defining the Review process
  • Batch Record SOP development
  • Roles and responsibilities of reviewers both Quality and Operations
  • Effective review practices and tools to identify discrepancies

Lecture 3: Methods for Data Review and Actions taken for Deviations 

  • Review of Analytical Data
  • Out-of Specification test results and deviations
Lecture 4: Case Study – Review of a Mock Batch Production Record 


In the realm of pharmaceuticals, biologics, and medical devices, Regulatory Agencies mandate the presence of meticulously crafted written procedures, known as batch records, to document production and process controls. These critical records stand as a testament to compliance, providing a comprehensive account of all essential processing parameters tied to the manufacturing process.

In this seminar, you will discover how the Batch Record process is vital in properly documenting and validating the entire production and manufacturing journey, guaranteeing adherence to strict regulatory standards. Through in-depth analysis, we'll explore each indispensable element of the batch record review process, empowering you to excel in regulatory compliance and elevate your industry prowess.

Learning Objectives:

  • Recognize regulatory requirements for batch records and batch record review
  • Discover the essentials of batch record reviewer qualifications and training
  • Establish a working relationship between production and quality reviewers
  • What to do when a batch fails to meet specifications (discrepancies and deviations)

Who Should Attend: 

  • Quality Assurance Departments
  • Manufacturing Departments
  • Validation Departments
  • Documentation Departments
  • Production Departments
  • All professionals who review batch records
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