The CAPA Confidence Clinic:
The CAPA Confidence Clinic:
FDA Rules for Effective CAPA Systems, Failure Investigations and Complaint Management
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.
You'll learn:
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
The CAPA Confidence Clinic:
FDA Rules for Effective CAPA Systems, Failure Investigations
and Complaint Management
Course Curriculum:
Regulatory Requirements for CAPA
FDA’s requirements for Corrective and Preventive Action systems
Specific GLP, Drug GMP, and Medical Device CAPA regulations
Why CAPA systems continue to be at the top of FDA’s enforcement list
Role of CAPA in meeting global rules and standards
Elements of Effective CAPA Systems
Framework for a compliant CAPA system
Where and how the CAPA feedback loop improves your overall quality system
Definitions of a correction, corrective action, and preventive action – and why the difference matters
How companies like yours are organizing their CAPA systems
CAPA Tools
CAPA data sources – gathering feedback from throughout your organization
Recommended flow chart for CAPA data collection and closure
Review of some commercially available CAPA management systems
Key points to consider in picking the right CAPA tracking tools to match your needs
What to Look for in Failure Investigations/Root Cause Analysis
Key objectives and phases of effective failure investigations
How to conduct a proper failure investigation to its root cause
00S (Out-of-Spec) investigations -- special considerations and rules
Failure Investigations tools
What they are and how best to apply them
How to document and report your findings (and to whom)
Trending Requirements and CAPA
Drug and device trending requirements – what and when to trend
Use of statistics to find and fix CAPA problems
Often overlooked but critical sources of internal and external feedback
Use of Risk (Process, Product) to determine when and if to escalate an observation to a CAPA
Denise Dion, EduQuest 18 years as FDA investigator and trainer and co-editor, FDA Investigations Operation Manual (IOM) |
Denise Dion is a Vice President of Regulatory and Quality Services with EduQuest. She spent 18 years of her career with the FDA, where she served as an Office of Regulatory Affairs (ORA) headquarters’ authority on agency-wide inspections and investigations. She developed many of FDA’s inspection guidance and training materials, including serving as the primary editor of the Investigations Operations Manual (IOM). Denise was the primary contact for interpretation and request for changes and additions to the IOM. In addition, she was one of the authors and trainers of the Quality System Inspection Technique (QSIT). For her EduQuest clients, Denise provides regulatory guidance and regularly conducts facility audits to assess compliance with drug, medical device and biologics regulations. She also develops inspection preparedness training. She is the author of the EduQuest Advisory on “Using FDA’s Own Playbook to Prepare for Your Next Audit”.
“Denise was very obliging and answered all my questions in depth, so I definitely feel more confident in my new role as CAPA specialist. She [also] did an excellent job of explaining good CAPA reporting. ” (Effective and Compliant CAPA Systems course, July 2009, Dublin, Ireland)
“Denise was excellent!” (Design Control for Medical Devices course, March 2011, Anaheim, CA)
“EduQuest has really helped us expand our quality system beyond ISO/IEC 17025 to the FDA requirements. We are much more confident in meeting our FDA needs! We are able to speak the language now as well. And we enjoyed Denise Dion’s style and stories. Even though everyone wanted to be told exactly how to do things, she was able to get across that we have to implement the regulations for ourselves and DOCUMENT why! ‘If it’s not documented, it doesn’t exist’ has become a constant quality slogan around here.” (Quality Manager, Blacksburg, VA) |
2012 Course Schedule:
September 27-28, 2012: Hilton Garden Inn, Frederick Maryland (near Baltimore, Maryland and Washington, DC) www.frederick.stayhgi.com. Fly into Baltimore-Washington International (BWI) Airport or Washington Dulles International (IAD) Airport, each approximately a 1-hour drive from Frederick.
Day 1: 8:30 am. – 5:30 pm; Day 2: 8:30 am – 12:30 pm.
Lunch on Day 1 and refreshments provided throughout the program.
To be notified when additional dates and locations are confirmed, subscribe to EduQuest’s free monthly newsletter delivered by email, EduQuest-ions & Answers. Click here to subscribe.
This course can be delivered directly at your facility, when and where convenient for you and your colleagues. Request a price quote from ClarenceDanielson@EduQuest.net.
Class registration is easy. To enroll or get more details:
(download
Registration Form for September 27-28, 2012 course in Frederick, MD)
Or Email Martin at Info@EduQuest.net
Or call +1 (301) 874-6031 between 9 a.m. and 5 p.m. Eastern U.S. Time
Tuition for The CAPA Confidence Clinic is $1,495. Register 5 students for the price of 4. Significant discounts also are available for teams of 2 or more from the same company who register together.
Combine this course with the 3-day FDA Auditing of Computerized Systems and Part 11/Annex 11 course (offered on Monday through Wednesday in September 2012 in Frederick, MD) and save $495 on the combined course tuition.
RETURN TO EDUQUEST CURRENT COURSES SUMMARY PAGE HERE
EduQuest: EDUcation: QUality Engineering, Science and Technology www.EduQuest.net +1 (301) 874-6031