How To Create An Effective And Compliant Batch Record Review Process – Webcast On-Demand

How to Create an Effective and Compliant Batch Record Review Process – Webcast On-Demand

$199.00

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.

Product Description

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
  • Management
  • Training
  • Regulatory
  • Technical Operations
  • Manufacturing

 

For Customer Care and Group Discounts – Please Contact Us
Phone: (+1) 844.686.5750
Email: info@windshire.com

Video Excerpts– See complimentary excerpts from the webcast

Rounding Numbers for Reporting Analytical Data

Batch Record Review…What To Look For…

Instructor Profile

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.

Refund Policy – Courses and Webcasts

Registrants may cancel up to two working days prior to an on-line course or webinar start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. On-site training can be cancelled up to ten business days prior to training. Windshire will be compensated for any travel cancellation fees. Courses and webinars may be cancelled due to unavoidable factors. Registrants will be notified if a cancellation occurs. Attendees can choose between the recorded (on-demand) version of the webinar or a full refund for any Windshire cancelled webcast.

We encourage feedback from our clients. To contact us, please email info@windshire.com or call (+1) 844.686.5750.

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