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Effective 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
- Regulatory requirements for batch record review
Overview of the webinar
In this webinar attendees will 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.
Who should attend?
- Quality Assurance batch record reviewers
- Production personnel and Production Managers who review batch records
Why should you attend?
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.
- 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)
Faculty - Miss.Danielle Delucy
Danielle DeLucy, MS, is the 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.