Batch Record Review and Product Release
Learn what regulators expect from batch record review, what to check in each record, how to qualify reviewers, and what to do when a batch fails to meet specifications.
Speaker
Danielle DeLucy
Pharmaceutical quality consultant · ASA Training and Consulting, LLC · MS
Overview
Regulatory agencies expect firms to keep written procedures for production and process controls, known as batch records, and for the process used to review them. This 60-minute batch record review training walks through each element of a compliant review system.
A strong review process documents every critical processing parameter in the manufacture of pharmaceuticals, biologics and medical devices. You'll learn what to look for when reviewing a record, including good documentation practices, compliance with critical quality attributes and critical processing parameters.
The session also covers the skills and tools reviewers need, how production and quality reviews should line up, how to train reviewers until they are qualified, and what to do with discrepancies and deviations before product release.
Why attend: Weak batch record review can let documentation errors and out-of-specification batches slip through to release. This session helps you meet regulatory requirements and build a review process that holds up. It suits quality assurance batch record reviewers, production personnel and production managers who review batch records and need a consistent approach shared by production and quality.
What’s covered
- Regulatory requirements for batch records and batch record review
- What to check: good documentation practices, critical quality attributes and critical processing parameters
- Skills and responsibilities of an effective batch record reviewer
- Tools for effective batch record review
- Keeping production and quality reviews aligned
- A training plan for reviewers and when they count as qualified
- Handling batches that fail specifications: discrepancies and deviations
Who should attend
What you get
About the speaker
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.
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