Nonconformances, out-of-specification results, and protocol deviations are facts of life in drug and device manufacturing and clinical trials. Ensure compliance — and success in your business — when you transform your root cause analysis and corrective and preventive action (CAPA) investigations.

In this virtual 3-day workshop presented by James Vesper, PhD, MPH, of ValSource Learning Solutions, you’ll sharpen your investigation skills, use root cause analysis to overcome obstacles, and develop unparalleled CAPA plans that will strengthen your business operations.

Using valuable tools such as data collection sheets, checklists and interview worksheets, workshop attendees will add a wide variety of problem-solving, interviewing, and data collection techniques to their professional toolboxes. They’ll hone their skills in creating a clear and complete picture of what caused or contributed to an incident, and strategize together in an interactive setting on how to prevent these issues from happening again.

 

Who Will Benefit

  • CAPA managers 

  • QA/QC managers and directors 

  • Compliance officers 

  • Training managers 

  • GCP, GLP and GMP professionals 

  • Regulatory affairs managers 

  • Quality engineers 

  • Anyone operating under FDA regulations for manufacturing and research who is seeking to improve an organization’s CAPA activities and investigations 

Group exercises during the workshop will allow attendees to:

Demonstrate the importance of a team approach when conducting an investigation.

Explore risk-based alternatives when a definitive root cause can’t be determined.

Review and critique a real-world investigation report.

Gain insights into applying risk-based provisions as mandated in the new Quality Management System Regulation (QMSR).

Other Workshop Takeaways:

  • Understand regulatory authorities’ expectations of investigations, CAPAs and investigation reports.
  • Analyze and identify four different investigation report audiences and what each is expecting to see in the report.
  • Differentiate between six different accident/incident models and how they can be applied during an investigation.
  • Discern between root causes, contributing causes and proximal causes.
  • Explain why “human error” is not a valid root cause.
  • Develop an investigation plan for a significant incident.
  • Make sense of the relationship between causes and corrections/corrective actions.

If you conduct, review or approve investigations in product development, quality assurance, clinical trials, laboratories, operations, technical services or maintenance/engineering, this virtual workshop should be a priority in your quest for learning.

Please note: To ensure an exceptional learning opportunity, class size for this workshop will be limited to just 25 seats. Once those seats are filled, we’ll start a waitlist for future cohorts.

Bring best practices on root cause analysis and CAPA investigations to your workplace.

REGISTER TODAY

Meet Your Presenter 

James Vesper
James L. Vesper, PhD, MPH
Director, Learning Solutions
ValSource

James L. Vesper, PhD, MPH, director of ValSource Learning Solutions, designs and develops instructional courses and workshops for the pharmaceutical and biopharma industries. Before joining ValSource in 2017, he established and is President of the firm LearningPlus, Inc. and has had more than 35 years’ experience in the pharmaceutical industry. Dr. Vesper worked 11 years at Eli Lilly and Company, first as a Corporate Industrial Hygienist, then in Corporate Quality Assurance, where he was responsible for issues concerning the manufacture and testing of parenteral products made at Lilly facilities and third parties worldwide. His last assignment at Lilly was as Project Leader of Good Manufacturing Practice (GMP) Education and Instruction, establishing the department and its mission.