presents a proven, 12-hour training class for FDA Quality System Improvement:              

5-Star Excellent Rating

 

(rated 5 out of 5 stars by 94% of previous students)

 

The CAPA Compliance Clinic:

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

October 19-20, 2017 * Near Baltimore/Washington, DC

Denise Dion, The CAPA Clinic Instructor

 

      Identify the best CAPA data sources and gather useful feedback throughout your organization and operations

 

      Select and apply the optimum CAPA tools to resolve real-world quality issues

 

      Conduct a thorough failure investigation -- as defined by the FDA -- and accurately identify root causes of non-conformances

 

Get practical, interactive classroom training

from Denise Dion, former FDA investigator and now expert advisor

to industry leaders worldwide.

 

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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.

Examine The CAPA Compliance Clinic training curriculum

Review the qualifications & experience of your course instructor

See what other students say about this course and the instructor

Check the latest schedule of course dates

Get class registration and tuition information -- learn how to register

 

In just 12 hours, get the confidence and training

to ensure your CAPA program and non-conformance investigations

meet FDA's expectations and your own quality system 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:

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Course Curriculum:

The CAPA Compliance Clinic:

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

 

Class Schedule:

Day 1: 8:30 a.m. – 5:30 p.m; Day 2: 8:30 a.m – 12:30 p.m.  U.S. Eastern Time

 

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

Benefit from interactive exercises to apply and retain your learning.

 

The CAPA Compliance Clinic will offer engaging and informative exercises designed to help you apply the course concepts, terms and tools to real-world problems you’re likely to face back at your job. You'll determine if typical corporate CAPA policies and site SOPs meet the letter and spirit of QSR and ISO requirements. Then you'll move on to assess five different CAPA software tools and determine how they might meet your specific needs and applications. You'll also review real-world complaint forms and non-conformance investigation reports to determine if they warrant opening a CAPA and then tracking your team's follow-up, including management communication, root cause analysis, and the ultimate close-out of the CAPA --documenting each step to the satisfaction of an FDA or third-party auditor.

 

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Why trust your training investment with EduQuest?

 

EduQuest celebrates 20 years of service to FDA-regulated companiesEduQuest is a global team of FDA compliance experts headquartered near Washington, DC. Celebrating its 20th year of service to FDA regulated industry, EduQuest was founded in 1995 by three former FDA rule-makers and expert field investigators.

 

Since that time -- through hundreds of training classes and consulting assignments worldwide -- EduQuest has helped thousands in the medical device, pharmaceutical, biologics, food and tobacco industries better understand FDA expectations, prepare for FDA inspections, resolve FDA enforcement disputes, and upgrade their Quality Systems to world-class standards.

 

"Unsolicited plug: EduQuest seminars are excellent! If you can attend, you should. I've been to several of your seminars over the years, enjoy them, and always leave with a pile of new information." (Doug Finner, Elbit Systems, May 2011)

 


About your Course Instructor:

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

 

Denise Dion, CAPA Authority and Former FDA Investigator

 

Denise Dion, EduQuest

  • 18 years as an expert FDA  investigator and trainer

  • Co-author of FDA's Quality System Inspection Technique (QSIT)

  • Member of FDA's Design Control Inspection Strategy Team

  • Co-editor, FDA Investigations Operation Manual (IOM)

  • In-demand Quality System advisor and trainer for device-makers worldwide

 

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 FDA's Quality System Inspection Technique (QSIT) and a member of FDA's Design Control Inspection Strategy Team.

 

For her EduQuest clients, Denise provides regulatory guidance and regularly conducts facility audits worldwide to assess compliance with drug, medical device and biologics regulations. She is the lead instructor for EduQuest's training classes on CAPA, QSR Compliance, and Design Control. She also develops inspection preparedness training. Denise is a frequent guest speaker for organizations such as FDAnews, FOI Services, She is the author of such EduQuest Advisories as “Using FDA’s Own Playbook to Prepare for Your Next Audit”, "Verification vs. Validation: FDA's Expectations and Why the Difference Matters", and "The Four Pillars of QSR Compliance".

 

Here's what other students say about this course

and the course instructor:

 “Denise’s extensive experience and the explanation of her real-life examples were great. She is really well read, as evident in her examples. I also liked the smaller, intimate class size with just the right amount of exercises and length of exercises.” (H.V., October 2015)

“Great content. Course instructor was excellent – loved the real-life examples! Good variety of lecture, exercises and breaks! As a result, we will do better investigations and much better investigation reports.” (J.B., October 2014)

“[It was good] being able to interact and get the perspective of a former FDA inspector. Also good to get an inside look on what the FDA is looking for and what they expect.” (L.J., October 2015)

"Denise has huge knowledge about CAPA systems and what the FDA expects." (S.P., April 2015)

 “Excellent! Well explained and easy to understand. [Included] real-life examples and explanation of answers. Instructor [is] well versed in subject.” V.N., October 2014)

 “Excellent…experience of trainers, the use of actual cases. Exercises were really good. As a result, I’m going to improve my CAPA investigations process and implement other investigation tools” (A.C., October 2014)

 “The exercises provided real-life situations and application of the concepts.” (C.W., October 2014)

“Denise is a very entertaining instructor, one of the best I've ever met...The class was very engaged.” (April 2013)

 

"The strengths of this class are Denise's knowledge and communication skills plus the informational documentation provided." (September 2012)

 

“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. ” (July 2009)

 

“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)

 

Latest Schedule of Course Dates:

 

The CAPA Compliance Clinic:

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

 

Thursday through Friday Morning

October 19-20, 2017

 

Frederick, Maryland

Hilton Garden Inn, Frederick Maryland (near Baltimore, Maryland and Washington, DC).

Hilton Garden Inn Hotel in Frederick, Maryland

 

Class Schedule:

Day 1: 8:30 a.m. – 5:30 p.m.; Day 2: 8:30 a.m. – 12:30 p.m.  U.S. Eastern Time. Continental breakfasts, lunch on Day 1 and refreshments will be provided during the class.

 

Fly into Baltimore-Washington International (BWI) Airport or Washington Dulles International (IAD) Airport, each approximately a 1-hour drive from Frederick.

 

For sleeping room reservations, book your room online at the Hilton Garden Inn, or call +1 (240) 566-1500.

 

Discounted sleeping rooms (single or double) for $122 per night (plus tax) are available for EduQuest class attendees until Monday, October 2, 2017. After October 2, 2017, sleeping rooms may still be available but likely will be at a higher rate.

 

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. For details, email EduQuest.

 


 

Registration and Tuition Information --

Class registration is easy. To enroll or get more details:

 

Sign Me Up!

 

1. Click on red button to download Registration Form, then fax to EduQuest at +1 301-874-6031 or email to EduQuest.

2. Or Email Info@EduQuest.net with any questions you may have about the course content or logistics.

3. Or call +1 (301) 874-6031 between 9 a.m. and 5 p.m. Eastern U.S. Time and charge your tuition to a major credit card

(Visa, MasterCard, American Express).

 

Tuition for The CAPA Compliance Clinic is $1,595, including all course printed materials; ample time to ask your questions to the expert instructors; one lunch; two continental breakfasts; refreshments throughout the program; and a Certificate of Attendance to document your training to FDA and third-party inspectors as well as management.

 

Save with a Team Registration:

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. Email Cindy at Info@EduQuest.net for details or look over the Corporate Group Discount Rates here.

 

Save with Extended Training:

Combine this course with the 3-day FDA Auditing of Computerized Systems and Part 11/Annex 11 Compliance course (offered on Monday through Wednesday in Frederick, MD) and save $695 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