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Overview

This course is designed to provide essential training for conducting Out of Specification (OOS) investigations in a GMP environment. A background discussion of the associated GMP documentation required to support the OOS investigation is included but the majority of time is spent detailing the who, what, when, how and why of the investigation, determining the extent of the investigation during Phase I and Phase II, documenting findings determining root causes and assigning corrective and preventative actions. An introduction to OOT (Out of Trend) results and an overview of the different types and how they are typically handled is also discussed using industry examples in the first session of this course.

This course is presented in a dynamic environment created by a power point presentation, interactive exercises, case studies and group discussion. Participants are welcome to bring their own examples for group discussion sessions.

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About AAPS Pharmaceutical Training Center


AAPS is registered as a private career college under the private career colleges act, 2005

If you are looking for a college that offers challenging programs in high demand fields, such as Pharmal, Biopharma, healthcare, Food, Medical Devices, Cosmetics, and Environmental AAPS is the place for you. Don't wait for life's rewards to come around - Make it happen by getting the education you need.

AAPS is the Canadian premier Life Sciences and Pharmaceutical training college. The school was established in 2003 to address the growing demands by healthcare manufacturers for better prepared and more practically trained applicants. In tailored response, AAPS was designed and made operational by a team of highly experienced industry experts with one mission in mind; to create professional skill development programs that would exceed industry-training standards".

Employing only leading industry professionals with decades of experience, AAPS is setting the standard for pharmaceutical, food and healthcare training and career advancement. These experts continually develop and update the diploma programs and certificate courses at AAPS to meet the rigorous demands of the industry. ...

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