Ensure compliance — and success — when you transform your root cause analysis and corrective and preventive action (CAPA) investigations.
Nonconformances, out-of-specification results, and protocol deviations are facts of life in drug and device manufacturing and clinical trials, but they don’t have to derail operations and affect your future business. Handled properly, they can be a learning opportunity that helps you ensure future success. The key is to be proactive — determining how and why it happened and implementing measures to keep it from happening again.
In this virtual workshop presented by James Vesper of ValSource Learning Solutions, you’ll learn how to investigate a problem thoroughly, use root cause analysis to get to the heart of it and develop a strong CAPA plan that will strengthen your operations and ensure the FDA that you have a handle on your business.
You will be provided with — and see demonstrations of — valuable tools based on some of the best practices in the industry, such as data collection sheets, checklists and interview worksheets.
Workshop attendees will examine a variety of problem-solving, interviewing and data collection techniques and learn ways to get a clear and complete picture of what caused or contributed to an incident and how to keep it from happening again.
Group exercises will demonstrate the importance of a team approach when conducting an investigation. You’ll review and critique a real-world investigation report and explore risk-based alternatives when a definitive root cause can’t be determined.
James L. Vesper, PhD, MPH, director of ValSource Learning Solutions, will lead you through a defined, logical process for root cause analysis and CAPA plan development that can be applied across the drug, medical device and clinical trial industries. He 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.
- Understand 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 significant incident
- Comprehend the relationship between causes and corrections/corrective actions
- Examine a model that can be used to illustrate multiple layers of control and mitigation
- Identify four different investigation report audiences and what each is expecting to see in the report
- Recognize options when a definitive root cause cannot be identified
If you conduct, review or approve investigations in product development, quality assurance, clinical trials, laboratories, operations, technical services or maintenance/engineering, this virtual workshop is a must. Join us by registering today.
Who Will Benefit
QA/QC managers and directors
GCP, GLP and GMP professionals
Regulatory affairs managers
Anyone operating under FDA regulations for manufacturing and research who is seeking to improve an organization’s CAPA activities and investigations