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Program Details

Time

2.5 Hours

Cost

CAD$250+HST (50% off of $500 – limited time only)

Location

Online

Workshop Overview

Level 2 of the Batch Record Review workshop delves deeper into the more complex aspects of batch record review in GMP compliance. This session focuses on advanced techniques for handling variances, deviations, and out-of-specification (OOS) results. Participants will learn to evaluate and address critical discrepancies, perform detailed investigations, and apply corrective and preventive actions (CAPA). Additionally, the workshop covers best practices for reviewing analytical data and technical documentation in batch records, ensuring product quality and regulatory compliance.

Who Should Attend​

This workshop is ideal for professionals with prior experience in batch record review or those who have attended Level 1. This workshop is particularly beneficial for quality assurance (QA) professionals, regulatory compliance specialists, and those involved in in-depth batch record analysis, including handling deviations and OOS investigations.

Workshop Outline

This workshop covers the following topics:
  • Advanced Techniques in Batch Record Review
  • Handling Variances, Deviations, and OOS Results
  • Investigating Discrepancies and Documentation Best Practices
  • Reviewing Analytical Data and Technical Documentation
  • The Role of Corrective and Preventive Actions (CAPA)
  • Ensuring Compliance with GMP Through Thorough Documentation

Learning Outcomes

Master Advanced Batch Record Review Techniques:

Gain the skills to perform thorough and advanced batch record reviews, ensuring compliance with GMP regulations.

Investigate and Address Variances and OOS Results:

Learn how to effectively investigate and resolve variances, deviations, and out-of-specification results, with an emphasis on documentation and traceability.

Evaluate Analytical Data in Batch Records:

Understand how to review and interpret analytical test results, ensuring the data aligns with product specifications.

Implement Corrective and Preventive Actions (CAPA):

Learn how to apply CAPA in response to batch discrepancies, ensuring continuous improvement and adherence to regulatory standards.

All participants will receive a certificate of attendance upon completion of the workshop.

Recorded Webinar – Mastering Batch Record Review – Level 2