The CAPA Confidence Clinic:

FDA Rules for Effective CAPA Systems, Failure Investigations and Complaint Management

 

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.

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:

After attending this course, you’ll be able to:

The CAPA Confidence Clinic:

FDA Rules for Effective CAPA Systems, Failure Investigations and Complaint Management

Course Curriculum:

 

Regulatory Requirements for CAPA

Elements of Effective CAPA Systems

CAPA Tools

What to Look for in Failure Investigations/Root Cause Analysis

Trending Requirements and CAPA

About your Course Leader:

25+ years of experience; 18 years as an FDA inspector and trainer

 

 

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)

 

2013 Course Schedule:

 

April 11-12, 2013: Hilton Garden Inn, Frederick Maryland (near Baltimore, Maryland and Washington, DC). For sleeping room reservations, visit www.frederick.stayhgi.com or call +1 (866) 909-6090. Use Group Discount code QUEST1 for sleeping rooms at $119/night plus tax. Discount rate available until March 18, 2013.

 

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.


 

Date and location don't fit your schedule?

On-site, on-demand training is available when and where you need it

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 April 11-12, 2013, course in Frederick, Maryland)

 

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, April 8-10, 2013, 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