How to Create an Effective and Compliant Batch Record Review Process Expert Panel Discussion-LIVE FREE Webcast
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Areas For Discussion
Creating an effective and compliant batch record review process is a critical component of a fully functioning, effective quality system.
This webcast will include a discussion of critical elements needed to achieve consistent results with your batch record review process. Real-life examples will be included.
Key elements of conducting successful batch record reviews:
- Regulatory requirements for batch record review
- What to look for while reviewing records, i.e., Good Documentation Practices, compliance to critical quality attributes and critical processing parameters
- Skills and responsibilities of a batch record reviewer
- Tools for an effective batch record review
- Ensuring production/operations and Quality reviewers coincide with their reviews
- Extensive training plan and when they can be considered “qualified” to review a record
Who Will Benefit
Industry professionals from many areas who may conduct or who help prepare for deviation investigations, including:
- Quality Assurance/Quality Control
- IT Professionals
- Technical Operations
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Our Expert Panel Biographies
Dr. James Blackwell, MBA is The Founder, President and Principal Consultant of The Windshire Group. Dr. Blackwell has been a prominent industry consultant for over twelve years, working on a wide variety of CMC and quality issues for a broad range of companies, investors, and product types at all stages of the product life cycle. Prior to consulting, he held several senior positions in technical operations, manufacturing and process development at prominent operating companies.
Dr. Blackwell is trained as a scientist, engineer and businessman. He received his Ph.D. in Chemical Engineering from Northeastern University. He received his dual M.B.A./M.S. Technology Management from the University of Maryland, and graduated with B.S. Chemical Engineering and M.S. Microbiology degrees from The Ohio State University.
Deborah Miller has had positions of responsibility and authority in regulated environments for over 30 years. She has diverse and extensive regulatory experience in assessment, remediation and fostering quality and compliance for biotechnology, in-vitro diagnostics, medical device, blood and plasma establishments and clinical and forensic laboratories. Deborah has been supporting development and operational teams in turning quality theory into practice as a consultant in Quality Management Systems for 12 years. She is a retired U.S. Army Medical Service Corps Officer and has a Master’s Degree in Laboratory Medicine from the University of Washington, Seattle.
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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