The Association for GXP Excellence (AGXPE) is pleased to announce our upcoming 90 minute interactive webinar hosted by Sam Sather, Keith Dorricott and Jennifer Lawyer of DIGR-ACT.
This session will be repeated again on Sept 23. Information in this session will be addressing the challenges in using root cause analysis to lead to effective risk assessment and CAPA for GXP.
This session will introduce the challenge and gaps from a process approach standpoint related to integration of essential human performance factors and critical thinking process support. They include highlights of the current significant challenges to performing risk assessment and CAPA without a modern approach to root cause analysis.
These sessions introduce to the GXP audience to DIGR-ACT as a solution to mature teams and processes in the era of big change.
This session can be linked to a follow-up session for an opportunity to take a deeper dive in a Train-the-Trainer workshop in October that trains you to adapt DIGR-ACT and how to train others (Refer to the October Train-the-Trainer sessions for more information and to sign-up; space is LIMITED .
Session Objectives:
DIGR-ACT Website – direct link: https://www.clinicalpathwaysresearch.com/digr-act
About the Presenters:
Sandra “SAM” Sather
Clinical Pathways
samsather@clinicalpathwaysresearch.com
https://www.clinicalpathwaysresearch.com
Sandra "SAM" Sather’s current focus of consulting is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 35 years of clinical experience, has a Bachelor of Science degree in Nursing and a Master of Science degree in Education with a Specialization in Training and Performance Improvement. SAM has been dual certified by the Association for Clinical Research Professionals (ACRP) for over 15 years as a CCRA and CCRC. She is a current ACRP Fellow, which is awarded to individuals who have made substantial contributions to the Association and the industry at large. She is a frequent speaker at industry conferences and has authored dozens of courses for clinical research training programs in various functional areas. She has multiple training, monitoring and project management experiences of diverse size, and objectives with a variety of global clients. In 2002 she co-founded Clinical Pathways (CP), LLC with Charles "Chuck" Sather.
Keith Dorricott
Dorricott Metrics & Process Improvement Ltd.
keith@dorricottmpi.com
https://www.dorricottmpi.com/
Keith Dorricott is the Director of Dorricott Metrics & Process Improvement Ltd., formed in 2016. Over a 12 year period, he worked in R&D, process development, and manufacturing whilst at Kodak Ltd. In 2005 he moved industry into the area of clinical trials and worked for two major CROs leading corporate process improvement. He qualified as a Black Belt in Six Sigma in 2002 and a Master Black Belt in Lean Sigma in 2007. He is an Ambassador for the Metrics Champion Consortium (MCC) and assists by facilitating work groups on centralized monitoring, central lab metrics, vendor oversight, Trial Master File, and by developing tools to assist with risk assessment & control and metrics selection & use. He received the MCC Champion Award in 2016 for making significant contributions to advancing the MCC mission to improve the efficiency, quality and effectiveness of clinical trials. Keith regularly presents at conferences such as DIA and SCOPE on the practicalities of quality risk management and risk-based monitoring and the definition and use of metrics. His passion is to help bring clinical research to the proficiency of manufacturing with root cause analysis skills – a fundamental requirement for effective process improvement.
