FDAnews Announces — Effective Root Cause Analysis and CAPA Investigations for the Life Sciences Virtual Workshop June 22-24, 2021

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CAPA failures show up in half of all warning letters. Register for this 3-day CAPA vWorkshop.

WCG FDANews

WCG FDANews

Deviations and failures may be a fact of life but understanding what happened — and why — is key to establishing corrective actions… and achieving success.

Upgrade root cause analysis and corrective and preventive action (CAPA) investigations in this virtual workshop.

James L. Vesper, PhD, MPH, Director of ValSource Learning Solutions, will lead attendees through a defined, logical process for root cause analysis and CAPA investigations that can be applied in the drug, medical device and clinical trial industries. He will help one develop the skills and techniques needed to conduct more effective investigations of quality incidents and identify ways to reduce the likelihood of recurrence. Dr. Vesper will empower one to:

  • Understand GMP regulatory authorities’ expectations of investigations, CAPAs and investigation reports
  • Differentiate between six different accident/incident models and how they can be applied during an investigation
  • Discern between root cause, contributing cause and proximal cause
  • Discuss why “human error” is not a valid root cause
  • Develop an investigation plan for any given incident
  • Explain the relationship between root, contributing and proximal causes to corrections and corrective actions
  • Examine a model that can be used to illustrate multiple layers of control and mitigation
  • Evaluate an interview using a guideline
  • Identify four different investigation report audiences and what each is expecting to see in the report
  • Recognize options of what can be done when a definitive root cause cannot be identified

If you conduct, review or approve investigations in product development, quality assurance, laboratories, operations, technical services, maintenance/engineering, or clinical research, this virtual workshop is a must.

Multi-attendee discounts available!
Significant tuition discounts are available for teams of two or more from the same company.

Virtual Workshop Details:
Effective Root Cause Analysis and CAPA Investigations for the Life Sciences
A Virtual Workshop Presented by WCG-FDAnews and ValSource Learning Solutions
Tuesday, June 22–Thursday, June 24, 2021, 11:00 a.m.–3:30 p.m. EDT
https://wcg.swoogo.com/root-cause-analytics-capa-investigations

Tuition:
$597

Easy Ways to Register:
Online: https://wcg.swoogo.com/root-cause-analytics-capa-investigations
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

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Michelle Butler
FDAnews
703.538.7600
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