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.
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).
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).
Danielle DeLucy
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 …
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