DUBLIN–(BUSINESS WIRE)–The “3-Hour Virtual Seminar on Handling OOS Test Results and Completing Robust Investigations” webinar has been added to ResearchAndMarkets.com’s offering.
The seminar aims to equip professionals in the pharmaceutical and biologics industry with the knowledge and tools necessary to effectively handle out-of-specification (OOS) test results and conduct thorough investigations.
This virtual seminar will delve into the regulatory requirements surrounding OOS investigations, providing attendees with a comprehensive understanding of the responsibilities of analysts, supervisors, and Quality Assurance (QA) personnel. Using a detailed flow chart, participants will be guided through the necessary steps and their proper sequence to ensure a well-structured investigation report that meets documentation standards.
Inadequate procedures for handling OOS situations and failure investigations have been a recurring issue leading to FDA warning letters. This seminar addresses these concerns by offering practical insights and best practices from industry expert Danielle DeLucy, MS. Danielle is the owner of ASA Training and Consulting, LLC, with over 15 years of experience in various Quality Management Roles within the pharmaceutical industry.
Key Learning Objectives:
- Understand the responsibilities of analysts and supervisors in handling OOS test results
- Gain insights into what the FDA looks for regarding human errors in investigations
- Identify triggers for initiating a full investigation
- Learn about the frequency for re-testing and re-sampling
- Implement effective Corrective and Preventive Action Plans (CAPA) to address issues
Key Topics Covered:
Session 1: Guidelines for Detecting an OOS or Atypical Result
- Definition of Atypical or Out of Specification Result
- Review of 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)
Session 2: Testing the Hypotheses Regarding Potential Root Causes
- Retesting
- Considering Other Batches
Session 3: Developing a Proper CAPA Plan to Address Corrective Actions
- How to Properly Document Findings
- Example of a Proper OOS Investigation Write-up
Speaker: Danielle DeLucy, MS
Danielle DeLucy is a seasoned industry expert with a strong background in Quality Management roles within the pharmaceutical sector. As the owner of ASA Training and Consulting, LLC, Danielle provides companies with training and quality systems assistance to ensure regulatory compliance. Her extensive experience in guiding Regulatory Health Inspections and fostering peer coaching has proven instrumental in helping companies facing warning letters and consent decrees.
For more information about this webinar visit https://www.researchandmarkets.com/r/504gl7
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