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The production and manufacture of pharmaceuticals, biologics, medical devices, etc., involve critical processing parameters. In order to properly document these processing parameters, a strong batch record review system is essential. This webinar with expert speaker Danielle DeLucy, MS, will analyze each of these necessary elements of the batch record review process. The speaker will cover key areas including, 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, more.
Key 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)
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Danielle DeLucy
Ms. 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.
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