Batch Record Review is a critical part of your operations. This practice is both a vital component to your quality efforts, and a global regulatory requirement. Your firm’s production efforts must be carefully documented. Standard Operating Procedures (SOPs), process controls, and deviations all fall under the purview of batch control. If your efforts are clear, concise, and repeatable, then you have nothing to fear. If your batch control documents are difficult to read, sloppy or worse – non-existent – then look forward to a litany of sanctions, recalls, and costly delays.
Since a strong batch record review system is essential for the manufacture of pharmaceuticals, biologics, medical devices, etc., why leave anything up to chance? Fortunately, there are simple steps you can take to ensure your efforts are efficient and compliant.
Join our interactive, 90-minute webinar where we will analyze each of the necessary elements of the batch record review process, 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
- 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, you will learn the fundamentals for reviewing batch records in a regulated environment.