This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.
A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
Areas Covered in the Webinar:
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
Instructor Profile:
Danielle DeLucy
Owner, ASA Training and Consulting, LLC
Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems.
Prior to this role, Ms. DeLucy has been in the industry for 15 years serving in numerous quality management roles, such as the director of product quality, the oversight of sterility assurance practices and provided QA oversight of numerous filling and packaging operations.