Best Practices for Deviation Investigations

Date : 27th September 2019 to 27th September 2019

Place : United States, Newark

Website :http://bit.ly/2ksiMo8

Contact Person:+1-(510)-868-1040

Description:

OVERVIEW This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using documents, interviews, and objective evidence to arrive at a root cause and a corrective and preventative action plan.Learn how to identify and classify deviations for easier management and investigation. LEARNING OBJECTIVES Describe what types of deviations exist Explain how to conduct a proper investigation Learn new tools for proper root cause analysis What things to avoid during the investigation How to properly document and manage the deviation details How to close the deviation and assess impact to the final product. WHY SHOULD YOU ATTEND FDA, EMA, and other international regulatory agencies require that there be a deviation investigation system as a subsystem of a company's overall quality system. Those involved in performing investigations, review and acceptance of non-conformance investigations, will learn how to conduct investigations, dos and don'ts in interviews, how to determine CAPA and more in this webinar. AREAS COVERED Review of regulatory requirements for investigations What is the definition of a Deviation? Types of Deviations/identification of Deviations Conducting the investigation Interviews - dos and don'ts Source Documents/Evidence Determining root cause and effective/sustainable CAPA Key elements of the investigation report WHO WILL BENEFIT? Mid-Level Managers Compliance Officials Manufacturing Personnel Laboratory Personnel 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. For more detail please click on this below link: http://bit.ly/2ksiMo8 Email: [email protected] Tel: +1-(510)-868-1040

Best Practices for Deviation Investigations will be held in Newark,United States on date 2019-09-27

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Deadline for abstracts/proposals : 27th September 2019

Keynote Speakers :

Venue :Online

Check the event website for more details.