Conducting Proper Deviation Investigations – Webcast On-Demand
In this 58-minute webcast, Danielle DeLucy, Subject Matter Expert in the areas of quality assurance and quality systems, provides proven success steps, tips and recommendations for conducting proper deviation investigations
What You Will Receive includes
- Webcast audio/video presentation
- 48-slide Powerpoint presentation
Why You Should Attend
- Deviations are EXPENSIVE! Incomplete deviation investigations is a top FDA finding during most audits. Learn expert success tips and recommendations from our subject matter expert.
Areas Covered in the Webcast
- Review of Regulatory Requirements for Investigations
- What is the Definition of a Deviation?
- Types of Deviations/Identification of Deviations
- Conducting the Investigation
- Interviews – dos and don’ts
- Source Documents/Evidence
- Determining Root Cause and Effective/Sustainable CAPA
- Key Elements of the Investigation Report
- And More…
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
For Customer Care and Group Discounts – Please Contact Us
Phone: (+1) 844.686.5750
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.
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.
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