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 demonstrations of — valuable tools, such as 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.
James L. Vesper, PhD, MPH, Director of ValSource Learning Solutions, 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. 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 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 significant 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 workshop is a must. Join us by registering today.
Who Will Benefit
- CAPA Managers
- QA/QC Managers and Directors
- Compliance Officers
- Training Managers
- GCP, GLP or GMP Professionals
- Regulatory Affairs Managers
- Quality Engineers
- Anyone seeking to improve an organization’s CAPA activities and investigations
Meet your presenter
James L. Vesper, PhD, MPH
Director, ValSource Learning Solutions
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 was president of the firm LearningPlus and has had more than 35 years’ experience in the pharmaceutical industry. Dr. Vesper worked 11 years at Eli Lilly & Co., 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.