this course highlights fda and eu regulations and how to successfully approach a failure investigation and engage in subsequent root cause analysis. the primary objective of this course is to recognize the value of conducting proper root cause analysis and documenting failure investigations. this root cause analysis training course is designed for personnel who are responsible for the failure and deviation investigation process in a gmp environment, specifically root cause analysis for capa. this course will be practical in its application and particularly valuable to those newer to this field or those who wish to refresh their knowledge of root cause analysis and investigative techniques. this course provides clarification of regulatory expectations and guidance, and the essential skills necessary to ensure effective and efficient investigations. participants will practice root cause analysis techniques and identify corrective and/or preventive actions towards successful remediation and closeout.
regulatory aspects of investigations and corrective/preventive actions from pharmaceutical, medical device and biological regulations are presented. however, the course material is presented, demonstrated and practiced so as to be applicable to any industry. however, what we need to determine is what caused the error. the “take home” of the course is utilizing all of these elements in a way that streamlines your investigation process and enables your company to conduct them in a timely fashion. each person attending a course will be asked to set up an attendee profile account during the registration process. if you are registering for others, please set up an account in the attendee’s name. if you are registering more than one person, you’ll need to set up a separate account for each attendee.
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it eases the training burden and promotes greater compliance because to capture other elements of the investigation. specialist in the pharmaceutical and biotechnology industries. pharmaceutical gmp professionals understand good manufacturing practice principles & regulations. join asq to save deficiencies of oos investigations continue to be the major cause of warning letters in the pharmaceutical industry. fda, investigation tools and techniques in pharmaceuticals pdf, pharmaceutical certificate courses, pharmaceutical gmp certification, investigation in pharma ppt
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