Get practical, interactive classroom training
from former FDA investigators and expert advisors
who train and consult for global industry leaders
Deficiencies in Corrective and Preventive Action (CAPA) systems continue to trigger the largest number of FDA 483s and Warning Letters.
Why do so many companies get it wrong? Perhaps they don’t understand that a successful, compliant CAPA system is so much more than just a tracking mechanism for non-conformances.
FDA wants your CAPA system to use a variety of tools and data resources to continuously monitor and improve quality throughout your product’s lifecycle.
What are those tools?
Where do you find the best data?
How do you prevent the same quality problems from happening again and again?
Start by attending this 12-hour interactive training class, taught by the same expert team that has trained many of FDA’s top managers and investigators.
In just a 12 hours, get the confidence and training
to ensure your CAPA program and non-conformance investigations
meet FDA's expectations and your own quality goals
If your current CAPA system is disorganized, poorly documented, or not supported by thorough failure investigations, you’re waving a red-flag to FDA inspectors and third-party auditors. Get your quality program back on track by building – step-by-careful step – a robust CAPA system that meets FDA’s latest expectations. Register today and discover how an effective CAPA system can reduce your manufacturing costs, minimize product recalls, and ensure product safety and effectiveness.
FDA’s requirements for CAPA systems
Why CAPA systems continue to be at the top of FDA’s enforcement list
Key elements of a compliant CAPA system
Distinctions among “corrections”, “corrective actions”, and “preventive actions” – and why it’s important to know the difference
32 important and often overlooked sources of CAPA data
A recommended flow chart for CAPA data collection and closure
How to pick the right CAPA tracking tools, in tune with your needs
FDA guidance for failure investigations and root cause analyses
Why so many failure investigations don’t identify the actual root cause
How to use “SOAP” to clean up your CAPA system
FDA’s trending rules – and how Quality Data Trending helps you better manage product risk
Lessons learned from recent FDA 483s and Warning Letters
After attending this course, you’ll be able to:
Upgrade your current CAPA system, giving you confidence the next time FDA visits
“Correctly” identify corrections, corrective actions and preventive actions so you don’t waste time and resources in solving the wrong problems
Speak the same language as the regulators when identifying and describing non-conformities
Identify the best CAPA data sources and gather useful feedback from throughout your organization
Select and apply appropriate CAPA tools to resolve real-world quality issues
Conduct a proper failure investigation and accurately identify root causes
Use statistics to find and fix CAPA problems