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How to properly investigate OOS/OOT Results


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OVERVIEW

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

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)

WHO WILL BENEFIT

Quality Assurance/Quality Control Directors, Managers, and Specialists 

Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists 

Engineering/Development Directors, Managers, and Specialists 

SPEAKER

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.

For more details click on this link:

http://bit.ly/2EJdUR7

You may also refer to this link:

https://www.trainingdoyens.com/product/50167-product-quality-review

https://www.trainingdoyens.com/product/50103-data-integrity-&-cgmp-compliance

https://www.trainingdoyens.com/product/50159-failure-mode-and-effect-analysis

 

Prices

Live Webinar : $199 Recorded Webinar : $219 Training DVD or USB Flash Drive : $399 Super Combo Offer 1 : $329 Super Combo Offer 2 : $499

Contact

Training Doyens
support@trainingdoyens.com

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