Investigating OOS and OOT Results

  • Speaker:Danielle DeLucy
  • Date: 29th June 2018 09:00 AM PST | 12:00 PM EST
  • Duration:60Min
  • Product Code:GRC-90335

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If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications.

Description:
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.

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.

Areas covered:

  • 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
Benefits/Target Audience:
  • QA managers and personnel
  • Analysts and lab managers
  • CAPA management
  • Regulatory affairs
  • Training departments
Instructor Profile:
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems  assistance in order to meet Regulatory compliance.

Prior to this role, Danielle 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.  Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at 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 to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.

Available Options

Live Meeting Access Single: Attend the meeting Live via Webex Meeting

$169

2 Single Live Access: 2 people can attend the meeting Live from any location

$279

3 Single Live Access: 3 people can attend the meeting Live from any location

$339

Recording: Access the training Recording for 6 months from any location

$259

CD: Shipped within 2 working days

$359

USB - Shipped within 2 working days

$389

Live + Recording: Attend Live Meeting Online + Access the recording for 6 months

$289

Live + CD: Attend Live Meeting Online + Get the training CD shipped for free

$389

Live + USB - Attend Live online + Get the training USB shipped for free

$409

5 Member Group: 5 can Attend Live Meeting Online from any location globally

$539

10 Member group: 10 can Attend Live Meeting Online from any location globally

$839

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