How to Create an Effective and Compliant Batch Record Review Process – Webcast On-Demand
In this 60-minute webcast, Danielle DeLucy, Subject Matter Expert in the areas of quality assurance and quality systems, reviews best practices for how to create an effective and compliant batch record review process.
Your Webcast Content Package includes
- 60-minute webcast audio/video presentation
- 39-slide powerpoint presentation
- BONUS MATERIAL:
- Batch Record Review SOP – The purpose of this two (2) page procedure is to define the parameters that need to be checked by QA during batch record review. It contains 20+ items, including general checks, batch master record/batch production record checks, packing operation sheet, etc.
- Rounding and Significant Figures SOP – This topic is an FDA inspection target area. The purpose of this two (2) page procedure is describing the rules for rounding numbers for the reporting of analytical data.
- Batch Record Review Checklist – This 2-page document template contains 25+ documentation items related to reviewing batch records.
Why Should You Attend
The batch review process is one of the most critical functions in the pharmaceutical industry. Our presenter, Danielle DeLucy, spent four years as a Batch Release Director for a biopharmaceutical company. Her tips and recommendations on creating an effective and compliant batch record review process is invaluable content for your company’s training program.
Areas Covered in the Webcast
Regulatory requirements for batch record review, 20 items to look for while reviewing batch records, tools for an effective batch record review, 6 Do’s and 7 Do Not’s when writing in cGMP documents, initial/date best practices, the process: performed by, recorded by and verified by. Missing data, voiding records, recreating records, rounding numbers for reporting analytical data, making corrections, skills and responsibilities of a batch record reviewer, recording time, compliance to critical quality attributes and critical processing parameters, skills and responsibilities of a batch record reviewer, ensuring production/operations and Quality reviewers coincide with their reviews, pitfalls to avoid, a training plan and when they employees can be considered qualified to review a record.
Who Will Benefit
Industry professionals from many areas who may interact directly with regulatory inspectors or who help prepare for inspections, including:
- Quality Assurance/Quality Control
- Technical Operations
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Phone: (+1) 844.686.5750
Video Excerpts– See complimentary excerpts from the webcast
Rounding Numbers for Reporting Analytical Data
Batch Record Review…What To Look For…
Danielle DeLucy is an industry veteran and specializes in the areas of Quality Assurance and Quality Systems as a consultant. 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 with oversight of sterility assurance practices and numerous filling and packaging operations. Danielle began her 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 with increasing 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: 1) are faced with warning letters and consent decrees; 2) wish to improve GxP practices; and 3) need to establish more robust quality systems.
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