9/07/2021
Dates: Two part series – Online live attendance mandatory
19 Oct 2021, 10:00 AM 1:00 PM (EDT)
AND
26 Oct 2021, 10:00 AM 1:00 PM (EDT)
Location: Live online
Registration: HERE
Cost: AGXPE Member – $399.00
Non-Member Registration – $449.00
Clinical Pathways is pleased to announce a partnership with the Association for GXP Excellence (AGXPE). AGXPE will present two part, interactive learning series hosted by Sam Sather and Keith Dorricott, founders of DIGR-ACT®.
This Train-The Trainer session will be run on two days, 3 hours each day, and will instruct attendees on how to adapt DIGR-ACT and how to train others. Space is LIMITED and online attendance is mandatory at both sessions.
DIGR-ACT® is a process for you to integrate into your operations to better support critical to quality factors and your quality system in a rapidly changing environment. Better handling and prevention of issues that matter means better project outcomes and less tears!
DIGR-ACT® is a solution developed by industry experts that addresses the gap of critical thinking skills needed in the era of quality by design and risk management.
DIGR-ACT® is an exciting composite of well-tested approaches from other industries synthesized specifically for the GXP professional.
This session is a deeper dive in a Train-the-Trainer workshop applying the DIGR-ACT® process. This Train the Trainer workshop is presented by the developers of DIGR-ACT® and experts in the industry.
This is for those interested in adapting or adopting DIGR-ACT® into their workplans.
The T-the-T sessions will take real industry case scenarios and apply DIGR-ACT®, assign the attendees guidance on approaches to adapting DIGR-ACT® into their current processes scalable to their needs, and support a plan to train-up the workforce for critical thinking and use of DIGR-ACT® proactively during project planning and also during risk and issues that matter management.
Session Objectives:
Discuss and review the components of DIGR-ACT® to support critical thinking to improve effectiveness of initiatives to transform processes to focus on Critical to Quality Factors.
Practice applying DIGR-ACT® process to industry project and study level use cases.
Guide in approaches to adopt DIGR-ACT® into a current quality system supporting a workforce maturity adaptable and scalable for the attendees’ organization.
Learn more about DIGR-ACT® with Clinical Pathway’s blog series! Some you may find interesting are:
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About the Presenters:
Sandra “SAM” Sather
Clinical Pathways
samsather@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
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.
- The Clinical Pathways Team
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