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.
Why should you attend
The lack of or Inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters.
Most companies have procedures but either they are not adequate or are not followed. This seminar will guide attendees through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations.
• 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
• QA managers and personnel
• Analysts and lab managers
• CAPA management
• Regulatory affairs
• Training departments
Industries who can attend
This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.
Faculty Danielle DeLucy
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.