Essential Tips For Effective Batch Record Reviews: Enhancing Process Capabilities with High-Stakes Importance

In today’s fast-paced environment, everything needs to be done right the first time. This is especially important when releasing pharmaceutical and biological products to the market.

Batch Record Review is a critical part of your operations.  It's not just an important part of your quality control - it's a mandatory global 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 there's nothing to worry about. But if your batch control documents are difficult to read, sloppy, or worse – non-existent – your company could be in big trouble. From sanctions to recalls, the cost of sloppy work can be astronomical. 

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 that you're meeting regulatory requirements and producing quality products.  

Reviewing a record is one of the most important jobs in a pharmaceutical firm. Reviewers are responsible for making sure the batch was made properly, according to procedure and regulatory requirements. 

By reviewing the batch record, QA and operations have the opportunity to catch errors before the product is released to the public. These reviews can save the company thousands of dollars in fines and ensure they are maintaining compliance with regulatory regulations.

Firms are required by Regulatory Agencies to establish written procedures for creating batch records, which document production and process controls. Moreover, written procedures for a batch record review process must also be in place to exhibit compliance. It is crucial to have a robust batch record review system to adequately record all vital processing parameters involved in the production and manufacturing of pharmaceuticals, biologics, medical devices, and other similar products. 

Attend the webinar to learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics, and medical devices environment. You will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of these critical documents and you will learn how to react to discrepancies found in these records.

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)

The webinar 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.

The content will be beneficial to anyone who works with batch record reviews or is impacted by their findings.
The following individuals or disciplines will benefit from attending this Webinar:

• Senior Management
• Compliance Auditors and Management
• Quality Assurance Personnel
• Quality Assurance Batch Record Reviewers
• Regulatory Affairs Professionals
• Quality Control Personnel
• Manufacturing Management and Scientists
• Auditors
• Production personnel and Production Managers who review Batch Records