Properly Investigating and Remediating OOS Results

Instructor: Danielle DeLucy
Product ID: 704351
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

This training program will describe when a full investigation should be triggered and the frequency for re-testing and re-sampling. Attendees will also learn how to implement corrective and preventive action plans (CAPA).

Why Should You Attend:

This 60-minute accredited course is designed to provide sound training on how to recognize and investigate atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate 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:

  • Guidelines for Detecting an OOS or Atypical Result
    • Definition Atypical or Out of Specification Result?
    • Review of the FDA Guidance for Industry on Investigating OOS Test Results
      • Phase I: Initial Laboratory Investigation
      • Phase II: Full Scale Investigation
    • Root Cause Analysis Methods
      • 5 Whys
      • Flow Charts
      • Checklists
      • Fishbone Diagrams
  • Testing the Hypotheses Regarding Potential Root Causes
    • Retesting
    • Considering Other Batches
  • Developing a Proper CAPA Plan to Address Any Corrective Actions
    • How to Properly Document Findings
    • Example of a Proper OOS Investigation Write Up

Who Will Benefit:

  • Lab analysts
  • Supervisors and managers in pharmaceutical or biological laboratories
  • Regulatory affairs
  • GMP auditors
  • Quality control and quality assurance personnel responsible for generating or evaluating test results in a regulated environment
  • Consultants
  • Training departments

Instructor Profile:

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.

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