Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

Gina Reo

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Ensure compliance when you transform your root cause analysis and corrective and preventive action (CAPA) investigations.

Deviations and failures may be a fact of life but understanding what happened — and why — will be key to establishing corrective actions… and achieving success. This virtual workshop will empower you to upgrade your root cause analysis skills and CAPA investigations so you can do just that within your organization.

You will be provided — and see demoexplain nstrations of — valuable tools like data collection sheets, checklists and interview worksheets, based on some of the best practices in the industry.

Attendees will examine a variety of problem-solving, interviewing and data collection techniques and understand ways to more fully appreciate what really caused or contributed to an incident (rather than “human error”) and how to address these factors effectively.

You’ll understand the importance of a team approach when conducting an investigation, with a group exercise to review and critique an investigation report. This will include exploring risk-based alternatives when a definitive root cause can’t be determined.

Our course instructor will lead you 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. The webinar will help you develop the skills and techniques you need to conduct more effective investigations of quality incidents and identify ways to reduce the likelihood of recurrence.

Workshop Takeaways:

  • 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
  • Explain why “human error” is not a valid root cause
  • Develop an investigation plan for a signficant incident
  • Comprehend 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, or maintenance/engineering, this virtual event is a must.

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Gina Reo, President, Quality Assurance Strategies LLC

Gina Reo, President, QAS, (Quality Assurance Strategies, LLC), private consultation for the Food and Beverage Industry specializing in Global Food Safety and Quality with expertise in Regulatory Compliance, Prop 65, Crisis Management, Business Integration and Due Diligence M & A Compliance Risk Assessments.

Formerly, Vice President, Food Safety, Weston Foods (WF), a GWL Canadian company and North American leader in bakery products. Transformed organization toward World Class Excellence for Food Safety within four years by framing Food Safety Roadmap Strategy for fast-tracking compliance to FSMA (Food Safety Modernization Act), SFCA (Safe Foods for Canadian Act) and new NLEA (Nutrition Labeling Education Act) for US and Canada compliance.

Over 25+ years of food safety and quality experience, after holding successive senior positions with Colgate-Palmolive, Coca-Cola, Bestfoods NA, Unilever, YUM! Brands and Quiznos (Board). Prior to joining Weston Foods, held position of Quality Director with Mondelez International (formerly Kraft Foods) in Europe, (Zurich, Switzerland) and Cadbury as QA Chocolate Director (Quality, Environmental, and Health & Safety) for NA/Europe/Global.

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