Conducting Proper Deviation Investigations Expert Panel Discussion LIVE FREE Webcast

Conducting Proper Deviation Investigations Expert Panel Discussion-LIVE FREE Webcast

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Areas For Discussion

A consistent approach to conducting pharmaceutical deviation investigations is a critical component of a fully functioning, effective quality system and FDA inspection target area.

This webcast will include a discussion of critical elements needed to achieve consistent results with your deviation investigation program. Real-life examples will be included.

Key elements of conducting a successful investigation include:

  • Methods of conducting an investigation, i.e., root cause analysis, 5 Whys, fishbone.
  • Interviews
  • Documents
  • Corrective action, preventive action
  • Product impact assessment
  • Importance of training
  • Expectations from regulatory agencies

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
  • Management
  • Training
  • Regulatory
  • Technical Operations
  • Manufacturing

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

Our Expert Panel Biographies

Dr. James Blackwell-The Windshire GroupDr. 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.

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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