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Faculty: Danielle DeLucy

  • Date: 2/18/2021 10:00 AM - 2/18/2021 02:00 PM
  • Location: Online Event


Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.

A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.. This seminar will analyze each of these necessary elements of the batch record review process.

Why You Should Attend:

  • 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
  • Production Departments
  • Validation Departments
  • Documentation Departments
  • All professionals who review batch records

Seminar Agenda    

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