Validation: Tried and True Success Lessons from the Front Lines Expert Panel Discussion-LIVE FREE Webcast
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Areas For Discussion
Is your quality system in a state of control? Conducting successful, documented validations provides firms with evidence to demonstrate a fully functioning, effective quality system to FDA investigators.
This webcast will include a discussion of how to achieve consistent results with your validations. Real-life examples will be included.
Key elements of conducting effective validations include:
- Documentation: IQ, OQ and PQ protocols
- Management oversight
- Validation Master Plan
- Regulatory requirements
- Personnel training
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.
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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