Handling OOS Test Results and Completing Robust Investigations

Instructor: Danielle DeLucy
Product ID: 704351
  • 17
  • December 2019
    Tuesday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 90 Min
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.

Live Online Training
December 17, Tuesday 10:00 AM PST | 01:00 PM EST | Duration: 90 Min

$249.00
One Dial-in One Attendee
$629.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD/USB Drive Free!

recorded version

$299.00
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 / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$429.00

Live + Training CD/USB

$529.00

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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

Who Will Benefit:

  • QA managers and personnel
  • Analysts and lab managers
  • CAPA management
  • Regulatory affairs
  • 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.

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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).

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