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Monday, June 27 • 10:45am - 11:45am
#144: Root Cause Analysis: Getting to ‘Why’ When Something Goes Wrong in Your Trial

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Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

It is easy to get lost in the terminology around understanding the why of a problem – audit finding, response, CAPA, root cause analysis, fishbone diagram. This practical session will get you working with others on an example issue, using some basic ideas on root cause analysis and trying them out. You will learn the basics of getting to why without worrying about the terminology. Getting to the why when something goes wrong on your trial means you have the best chance of determining ways to stop the same thing impacting your trial (or another one) again. It’s a key part of a learning organization.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Apply root cause analysis techniques to determine probable root causes of an issue (such as from an audit finding); Explain the purpose of root cause analysis.

Chair

Keith John Barber

Speaker

Facilitator
Helen Howitt



Chair
avatar for Keith Barber

Keith Barber

Executive Director, INC Research
Keith Barber has worked in Quality, Process, Training and Clinical management positions for over 20 years. He currently manages INC's Process Quality Management department, which includes CAPA management, controlled document management and internal GXP consultancy. Keith has also performed 'Quality Partnership' roles in CROs and has been responsible for developing and implementing significant process improvement initiatives.

Speakers
avatar for Helen Howitt

Helen Howitt

Director, Process Quality Management, INC Research


Monday June 27, 2016 10:45am - 11:45am
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA