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Handling OOS Test Results and Completing Robust Investigations - Webinar

  • ID: 4899737
  • Webinar
  • May 2019
  • Region: Global
  • 120 Minutes
  • Compliance Online
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.

Learning Objectives:

Learn the responsibilities of analysts and supervisors
Listen to what the FDA looks for in terms of human errors
Describe when a full investigation should be triggered
Describe the frequency for re-testing and re-sampling
Learn how to implement the corrective and preventive action plans (CAPA)
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
Note: Product cover images may vary from those shown
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.

Ms. DeLucy began her QA career as a quality control pharmaceutical microbiologist at Lancaster Laboratories, a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the quality management arena while increasing her responsibility. She has helped lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, she assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.
Note: Product cover images may vary from those shown