Recorded Webinar - Mastering Batch Record Review - Level 1

Program Details

Time

2 Hours

Cost

CAD$600+HST

Location

Online

Workshop Overview

Level 1 of the Batch Record Review workshop introduces the foundational concepts of Good Manufacturing Practices (GMP) and the essential components of batch record review. This session focuses on the regulatory requirements, types of regulated documents, and basic production and process controls. Participants will also learn the primary elements and techniques involved in batch record review, including the importance of accurate record-keeping, proper documentation practices, and handling minor variances or discrepancies.

Who Should Attend

Level 1 is designed for professionals new to batch record review, regulatory affairs, quality assurance, or those looking to enhance their understanding of GMP documentation. This session is particularly beneficial for those involved in manufacturing, quality control (QC), and anyone responsible for ensuring compliance with GMP standards.

Workshop Outline

This workshop covers the following topics:

Regulatory Requirements for GMP
Types of Regulated Documents in GMP
Introduction to Production and Process Controls
Elements and Techniques of Batch Record Review (Overview)
Basic Handling of Variances and Deviations
Documentation Best Practices and Common Issues

Learning Outcomes

Understand the Regulatory Requirements for GMP Records:

Gain foundational knowledge of the regulatory requirements for batch records and the significance of proper documentation.

Familiarize with Common Regulated Documents in GMP:

Learn about the different types of regulated documents required in GMP, such as Standard Operating Procedures (SOPs) and batch records.

Apply Basic Batch Record Review Techniques:

Understand the basic techniques for reviewing batch records, ensuring the documentation is compliant with GMP standards.

Identify and Address Minor Variances and Deviations:

Learn how to handle basic discrepancies and document findings for compliance.

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