Effective Batch Record Review

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

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 will analyze each of these necessary elements of the batch record review process. Upon completion of this session, you will learn the fundamentals for reviewing batch records in a pharmaceutical environment. You will hear about the proper training that must be demonstrated to be considered a suitable reviewer of these critical documents and you will learn how to react to discrepancies found in these records.

Areas Covered in the Session :

• Recognize regulatory requirements for batch records and batch record review
• Understand the essential and necessary qualifications and training of batch record reviewers
• Establish a working relationship between production and quality reviewers
• What to do when a batch fails to meet specifications (discrepancies and deviations)
• Parameters of efficient review of batch records – good documentation practices, compliance to essential quality attributes and critical processing parameters
• Skills and responsibilities of an effective batch record reviewer
• Tools to achieve an effective batch record review
• Ensuring Production and Quality reviewers coincide with their reviews
• Creating an extensive training plan for batch record reviewers and when they can be considered qualified  to review a record

Who Should Attend:

• Quality Assurance Departments
• Manufacturing Departments
• Production Departments
• All professionals who review batch records

Course Director: 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 has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.