How to properly investigate OOS/OOT Results at Training Doyens

Location Training Doyens, 26468 E Walker Dr, Aurora, Colorado, 80016-6104
Event Date(s) Tuesday March 6, 2018
Event Website Visit Event Website >
Event Category Business/Networking, Business Events

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/2GSsIxl 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


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