Properly Investigating Out of Specification (OOS) and Out of Trend (OOT) Results – Webcast On-Demand
In this 52-minute webcast, Danielle DeLucy, Subject Matter Expert in the areas investigating Out of Specification (OOS) and Out of Trend (OOT) results, provides proven success steps, tips and recommendations for identifying these results in your organization.
What You Will Receive includes
- Webcast audio/video presentation
- 43-slide Powerpoint presentation
Why Should You Attend
In this Properly Investigating Out of Specification (OOS) and Out of Trend (OOT) Results Webcast, Danielle’s proven success steps, tips and recommendations for identifying OOS and OOT results provides invaluable content for your company’s training program.
Areas Covered in this Webcast:
- FDA requirements for handling OOS/ OOT results
- Phase I- Laboratory Phase of Investigations
- Phase II a Full Scale Investigation
- Concluding an Investigation
- Out-of Trend investigations
- Common pitfalls during OOS Investigations
- Review of recent OOS related citations in Warning Letters
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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