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.
Why should you Attend:
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.
Areas Covered in the Session:
Skills and responsibilities of an Effective Batch Record Reviewer
Tools for Effective Batch Record Review
Ensuring Production and Quality Reviewers coincide with their Reviews
Who Will Benefit:
Quality Assurance Batch Record Reviewers
Production Managers who Review Batch Records
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 17 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.