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.
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
What to do when a batch fails to meet specifications (discrepancies and deviations)
Areas Covered in this 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.
Upon completion of this session, attendees will learn the fundamentals for reviewing batch records in a pharmaceutical environment. They will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of these critical documents and they will learn how to react to discrepancies found in these records.
Who Will Benefit:
Quality Assurance batch record reviewers
Production personnel and Production Managers who review batch records.
Danielle DeLucy, MS, is an Independent Consultant to the Biologics and Pharmaceutical Industries.
Danielle DeLucy, 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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