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

5-Star Excellent Rating

 

(rated 5 out of 5 stars by 89% of previous students)

 

The CAPA Compliance Clinic:

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

Available as an On-Site, On-Demand class

 Email Info@EduQuest.net to bring this class directly to your site -- when and where convenient for you

 

      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 former FDA investigators and now expert advisors

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)

 


About your Course Instructor:

Internationally recognized Device Quality System specialist;

35+ years of experience; 22 years as an FDA expert investigator, trainer and policy-maker.

 

 

Martin Browning,

President and Co-Founder,

EduQuest

  • 22 years as an expert FDA  investigator and trainer

  • Co-author of FDA's Quality System Regulation -- the QSR (21 CFR Part 820)

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

 

Martin Browning is the President and Co-Founder of EduQuest, Inc., a global team of FDA compliance experts based near Washington, D.C. Martin has more than 30 years of regulatory experience at the FDA and as a highly sought-after advisor to industry. His 22-year career at FDA included work in the field offices as an investigator and as a senior manager in the Office of Regulatory Affairs at FDA headquarters. He capped his FDA career by serving as a special assistant to the Associate Commissioner for Regulatory Affairs. He also served as vice chair of FDA’s electronic record and signature working group, where he helped draft the original 21 CFR Part 11 regulations. In addition, Martin served as the chair of the U.S. government’s ISO 9000 committee and was a member of the FDA committee that developed the medical device Quality System Regulation (QSR).

 

At EduQuest, Martin helps clients solve problems related to FDA regulation, quality assurance, software and systems engineering, and compliance auditing, including the assessment of vendors and outsourced operations. His specific experience also includes quality systems design, system design assurance and verification, and the validation of biopharmaceutical and device systems, processes and software. Martin was named Speaker of the Year in 2004 by the Institute of Validation Technology (IVT) and has received dozens of other awards from the FDA, DIA, ASQ, and other organizations.

 

Here's what other students say about this course

and the course instructor:

“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)

"The instructor 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)

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

 

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

 

“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. Even though everyone wanted to be told exactly how to do things, EduQuest 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

 

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.

 

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.

 


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