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.

1. GRC Training Solutions

2.  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.

3.  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.

4. * 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

5.  •QA managers and personnel
•Analysts and lab managers
•CAPA management
•Regulatory affairs
•Training departments

6.  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.

7. Live : For one participant
$129
Corporate Offer 1 : Max 3 - 5 Participants
$399
Corporate Offer 2: Max 10 Participants
$599
Recorded Webinar: Get unlimited access to the link for six months
$ 179
Get CD/DVD:
$259
Super Combo Offer 1: For One partcipant Live and Recorded webinar Only!
$309
Super Combo Offer 2: For One partcipant Live and Training CD Only!
$349.