Batch Record Review and Product Release

Why Should You Attend:

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.

A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.

This webinar will analyze each of these necessary elements of the batch record review process.

Learning Objectives:

• Recognize regulatory requirements for batch records and batch record review
• Discover the essentials of batch record reviewer qualifications and training
• Establish a working relationship between production and quality reviewers
• What to do when a batch fails to meet specifications (discrepancies and deviations)

Areas Covered in the Webinar:

• Regulatory requirements for batch record review
• What to look for while reviewing batch records, i.e., good documentation practices, compliance to critical quality attributes and critical processing parameters
• Skills and responsibilities of an effective batch record reviewer
• Tools for effective batch record review
• Ensuring Production and Quality reviewers coincide with their reviews
• Extensive Training plan for batch record reviewers and when they can be considered “qualified” to review a record.

Frequently Asked Questions:

1. Any recommendation or tips on reviewing raw materials, I mean raw materials listed in master batch records?
2. What if batch records are released from CMO and there are still corrections post disposition. What is the best way to amend any corrections to the batch records?
3. Would you expect to review the RM release record during executed batch records from CMO? Not all CMO is willing to provide that information because it could be general to all clients?

Who Will Benefit:

• Quality Assurance batch record reviewers
• Production personnel and Production Managers who review batch records.

Danielle DeLucy
Owner, ASA Training and Consulting, LLC

Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy 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.

Ms. DeLucy began her QA career as a quality control pharmaceutical microbiologist at Lancaster Laboratories, 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 lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, she assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.

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