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 18-19, 2017

Near Baltimore and Washington, DC

Denise Dion, former FDA investigator and QSR Compliance Basics instructor

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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Why you should attend:

 

 

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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, May 2011)

 


About your Course Instructor:

25+ years of experience; 18 years as an expert FDA investigator, trainer and policy-maker.

 

Denise Dion, former FDA investigator and QSR Compliance Basics instructor

 

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 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”.

 

Here's what other students say about this course

and the course instructor:

 

"Denise is very engaging and is a great presenter on the topic."

 

"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 that Denise 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."

 

"Denise is great. I really appreciate her knowledge, sharing of experiences, and overall demeanor."

 

“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:

 

QSR Compliance Basics:

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

Monday & Tuesday

September 18-19, 2017

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 EDUQST

 

Discounted sleeping rooms (single or double) for $122 per night (plus tax) are available until Friday, August 18, 2017. After August 18, 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:

 

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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 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 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 Info@EduQuest.net 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.

 


RETURN TO EDUQUEST CURRENT COURSES SUMMARY PAGE HERE

 

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