News & events

LIVE Webinar: Release or Reject? The Critical Role of Batch Records in Quality and Patient Safety

Speaker: Kirsten Farquhar, PharmD, BCSCP, CQA with Premier, Inc.

Date: September 22, 2026, 12 p.m. CST

Session Description:

For health systems purchasing products from 503B compounding facilities, they must ensure that the products are safe and effective. While batch record release is a valuable component to understand 503B facility operations as a whole, they are also a useful tool to determine how a 503B facility ensures the safety and efficacy of its products that are supplied to health systems and clinics. This presentation will provide an overview of the components of a batch record, key principles of good documentation practices to evaluate data integrity, as well as provide examples of what to look for to assess compliance.

Learning Objectives:

1. Describe the regulatory foundation and required elements of 503B batch production records
2. Explain the role of the Quality Unit in batch record review and final product release
3. Evaluate key release criteria, including testing, environmental data, and deviation management
4. Identify common deficiencies in batch records and release processes observed during audits and FDA inspections

The CE session is free and worth 1 contact hour. 

Register Today: https://event.on24.com/wcc/r/5445030/E334BF076EDB44AE36A5B3285FF57888