Blog — Clinical Pathways

Now Available! ICH E6(R3) Comparison Tool. Includes Final Principles, Annex 1, and draft Annex 2. Click here to purchase.

corrective action

Train-The-Trainer DIGR-ACT®: A Risk Assessment & Issues Management Critical Thinking Solution

9/07/2021

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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

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!

Live Webinar: Risk Assessment & CAPA without Tears: The DIGR-ACT® Critical Thinking Solution

8/03/2021

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Date: September 16th OR 23rd, 2021. Choose which date works for you.

Time: 10:30 AM - 12:00 PM EDT

Location: Interactive Webinar

Registration: September 16 Registration HERE September 23 Registration HERE

Cost: AGXPE Member – $79.00

Non-Member Registration – $89.00

Clinical Pathways is pleased to announce a partnership with the Association for GXP Excellence (AGXPE). AGXPE will present the 90-minute interactive webinar hosted by Sam Sather and Keith Dorricott, founders of DIGR-ACT®.

This session will address the challenges in using root cause analysis to lead to effective risk assessment and CAPA for GXP. It will also introduce the challenges 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.

Is Your Study High Quality? Investigator Warning Letter Issued

2/16/2021

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During the pandemic, onsite FDA inspections were temporarily suspended starting in March 2020 and restarted late summer. Our blog “FDA Resumes Domestic Inspections” describes the risk-based approach to remote assessments during that time period. This in part explains the long interval since the last warning letter. The first new warning letter after inspections resumed was issued to an investigator.