This session s a repeat of the Sept. 16 session. 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 .
About the Presenters:
Sandra “SAM” Sather
Clinical Pathways
samsather@clinicalpathwaysresearch.com
https://www.clinicalpathwaysresearch.com
Keith Dorricott
Dorricott Metrics & Process Improvement Ltd.
keith@dorricottmpi.com
https://www.dorricottmpi.com/
Association for GxP Excellence (AGxPE)
338 Buckingham Circle
Lower Salford, PA 19438
267.664.0157