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.
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.
This workshop covers the following topics:
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.
Note: Registration closes one week prior to the start of workshop. Workshop registration is intended for individual use only. Each registration grants access to one participant. If you plan to attend as a group or company team, please ensure that each participant is registered separately. Group rates and corporate packages are available—contact us for details.
Refunds are only available if cancellation is requested at least 48 hours before the workshop. No refunds will be issued for late cancellations.
