Blue abstract background with record keeping binders.

Pharmaceuticals

Batch Record Reviews

About the Course

Pharmaceutical batch records are essential to ensure that regulatory compliance and product quality attributes are achieved. This online course describes how to properly perform a batch record review. Topics in this eLearning course include: Regulations, Manufacturing Records, Packaging Records, Laboratory Records, and Issues and Deviations. After completing this training course, learners will be able to identify the GMP and cGMP requirements for batch records and recognize how to maintain GMP and cGMP compliance throughout the review process. The regulatory requirements of FDA are addressed with reference also made to the requirements of the EU.