EduQuest: A Global Team of FDA Compliance Experts   presents a proven, 2-day training class on FDA's expectations for your Quality System -- and the consequences of non-compliance

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(rated 5 out of 5 stars by 92% of previous students)


QSR Compliance Basics:

Complying with FDA's 21 CFR 820 Medical Device Quality System Regulation (QSR)


Monday & Tuesday, September 17-18, 2018

Near Baltimore and Washington, DC

Get interactive, real-world classroom training on the essential FDA Quality System rules you must know. 


The scope of FDA’s Quality System Regulation (QSR) is huge – more than 500 pages of rules and guidance – and non-compliance is not an option. Just within the past 18 months, more than two dozen medical device companies have received Warning Letters for deficient quality management programs, and several were threatened with removal of their products from the market.


Compliance with FDA’s Quality System approach is recognized globally as a pre-requisite not only for getting your product on the market but – just as importantly – keeping it there. This two-day QSR Basics course walks you through the requirements of 21 CFR 820, discusses how FDA’s rules correlate with ISO standards and ICH guidance, and examines current FDA inspection and enforcement priorities.


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Learn directly from former FDA device officials and industry advisors.

Learn straight from the source – former FDA inspectors, rule-makers, and trainers from the global consulting team of EduQuest, headquartered near Washington, DC. Instructors include one of the co-authors and trainers of FDA’s Quality System Inspection Technique (QSIT) and the founding editor and co-author of FDA’s “bible” for inspectors, the Investigations Operations Manual (IOM).

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Course Curriculum

QSR Compliance Basics:

Complying with FDA's Medical Device 21 CFR 820 Quality System Regulation


Class Schedule:

Day 1: 8:30 a.m. – 5:00 p.m.; Day 2: 8:30 a.m. – 5:00 p.m. U.S. Eastern Time


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,


  • 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:


"This was one of the best courses I have attended -- it was exactly what I needed!"


"These are great training courses which have already helped me with my job. Thanks very much!"


"The experience the instructor shared with great knowledge was great. The class was very informative. I truly enjoyed it."


"Informative and well-organized course. As a new RA/QA manager, this is a wonderful foundation for learning and helping my team. Thank you!"


"Well run and provided the depth I've been searching for."


"The instructor was truly fantastic. Her real-life experience, sense of humor and vast subject knowledge made this one of the best training classes I've attended."


“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:


QSR Compliance Basics:

Complying with FDA's Medical Device 21 CFR 820 Quality System Regulation

Monday & Tuesday

September 17-18, 2018

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


Class Schedule:

Day 1: 8:30 p.m. – 5:00 p.m.; Day 2: 8:30 a.m. – 5:00 p.m. U.S. Eastern Time

Continental breakfast, lunch and refreshments provided both days.


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

Hilton Garden Inn Hotel in Frederick, MarylandFor sleeping room reservations, book your room online at the Hilton Garden Inn or call +1 (240) 566-1500. Refer to reservation discount code EDUS16.


Discounted sleeping rooms (single or double) for $129 per night (plus tax) are available until Sunday, September 2, 2018. After September 2, 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:


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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 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 QSR Compliance Basics course is $1,595, including all course printed materials; ample time to ask your questions to the expert instructors; two lunches; 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 for details or look over the Corporate Group Discount Rates here.


Save with Extended Training -- Four-Day Medical Device Quality & Compliance Learning Package:

Combine the QSR Compliance Basics course with the two-day Design Control for Medical Devices course (offered immediately afterwards, on Wednesday and Thursday).


Save $593 on the combined tuition when you attend both courses. The combined tuition is $2,997, including hands-on training, all course materials, continental breakfasts, lunches, refreshments, and the opportunity to learn and interact with some of the top FDA compliance experts in the nation.




EduQuest: EDUcation: QUality Engineering, Science and Technology   +1 (301) 874-6031