ComplianceOnline

Handling OOS Test Results and Completing Robust Investigations

Instructor: Danielle DeLucy
Product ID: 704351
  • 10
  • July 2017
    Monday
  • 10:00 AM PDT | 01:00 PM EDT
    Duration: 60 Min

Live Online Training
July 10, Monday 10:00 AM PDT | 01:00 PM EDT | Duration: 60 Min

$199.00
One Dial-in One Attendee
$529.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Get CD free on purchase of Group ticket

recorded version

$249.00
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 48 hrs after completion of Live training

Training CD

$329.00
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 after completion of Live training

Combo Offers

Live + Recorded Version

$349.00

Live + Training CD

$429.00

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

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

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.

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.

Follow us :
Project Management in Human Resources - 80334SEM
Computer System Validation - Reduce Costs and Avoid 483s

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading