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Effective Batch Record Reviews to Improve your Process Capabilities

Duration : 60 Minutes

Danielle DeLucy, Pharmaceuticals, Biotechnology

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, suc Read more

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. 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 with expert speaker Danielle DeLucy, MS, will analyze each of these necessary elements of the batch record review process.

Course Objectives:

• 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)

Why Should You Attend:

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.

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.

Course Outline:

• 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 can they be considered “qualified” to review a record

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
•  Participation Certificate
•  Access to Signup Community (Optional)
•  Reward Points

Who Will Benefit:

• Quality Assurance batch record reviewers
• Production personnel and Production Managers who review batch records
• Compliance Auditors
• Manufacturing Management & Scientist
• Other professionals who review batch records

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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Subject : Effective Batch Record Reviews to Improve your Process Capabilities

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