How to properly investigate OOS/OOT Results

Date : 6th March 2018 to 6th March 2018

Place : United States, Aurora

Website :http://bit.ly/2E4Qrgb

Contact Person:Training Doyens

Description:

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 For more details click on this link: http://bit.ly/2E4Qrgb 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 Ticket Price: Live Webinar : $199 Recorded Webinar : $219; Training DVD or USB Flash Drive : $399; Super Combo Offer 1 : $329; Super Combo Offer 2 : $499

How to properly investigate OOS/OOT Results will be held in Aurora,United States on date 2018-03-06

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Deadline for abstracts/proposals : 6th March 2018

Keynote Speakers : 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

Venue :Training Doyens, Aurora, CO, United States

Check the event website for more details.