EduQuest: A Global Team of FDA Compliance Experts   presents a proven training class on FDA rules and expectations for

Essential Design Inputs, Essential Design Outputs, Design Validation, Design Verification, Design Transfer, and more   

5-Star Excellent Rating

 

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

 

Design Control for Medical Devices:

Denise Dion, former FDA investigator and Design Control Class instructor

 

Meeting FDA's 21 CFR 820.30 Rules

for Quality Design and Manufacturing

 

Wednesday & Thursday

September 20-21, 2017

Near Baltimore and Washington, DC

Learn how FDA expects you to develop, implement, and manage Design Controls for your products -- all from Denise Dion, the globally respected device compliance expert and ex-FDA investigator.

- Focus on overcoming one of the biggest obstacles that routinely confounds device-makers: accurate and consistent product design transfer to actual manufacturing operations.

- Better understand what to include in the product Design History File (DHF) and Design Master Record (DMR) -- and just as importantly -- what FDA inspectors look for when they review your records.

- Know when and how to validate or verify product design, and what's the important difference between the two.

Learn how to comply with FDA’s growing expectations for Device Design Control and successful transfer to the production line.

 

Design History Files…Device Master Records…Essential Design Inputs. Design control is required for all medical devices sold in the U.S., EU, Japan, and several other countries. In addition, there’s relentless pressure from both FDA and Congress to improve device design control and manufacturing.

 

To ensure you’re meeting FDA and global standards, enroll in this proven EduQuest course, which has successfully trained thousands of medical device quality professionals worldwide since 2008.

 

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Receive two days of world-class Quality System training direct 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. Your instructors include Denise Dion, one of the co-authors and trainers of FDA’s Quality System Inspection Technique (QSIT), the founding editor and co-author of FDA’s “bible” for inspectors, the Investigations Operations Manual (IOM), and a member of FDA's original Design Control Inspections Strategy team.

 

The goal of this training course is to give you real-world, step-by-step compliance information -- not only to meet the regulations, but also to ensure you're making the most safe and effective products possible. Through plain-English instruction, detailed course materials, and interactive exercises that reinforce the lessons (not to mention making the classroom more fun and interesting), you learn to cost-effectively comply with FDA’s quality system rules and related international standards.

 

Examine the Design Control 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

Why you should attend:

 

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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.

 


Course Curriculum

 

Design Control for Medical Devices:

Meeting FDA's 21 CFR 820.30 Rules for Quality Design and Manufacturing

 

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

 

Who should attend:

 

This course is designed specifically to help device industry managers, engineers, designers, QA/QC specialists, and regulatory affairs professionals improve their company’s compliance with FDA’s 21 CFR 820.30 rules for quality design and manufacturing – which also impact product R&D specialists, scientists, medical professionals, and software and manufacturing engineers.

Benefit from interactive exercises to apply and retain your learning.

 

The 16-hour Design Control for Medical Devices training class offers 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 and your team will develop a Product Requirements Document for a new device based on a marketing survey, human factors report, and predicate packaging and labeling. Then you'll develop product Design Outputs that trace back to those requirements and proceed to Design Verification and Validation. You'll work through a Design Transfer exercise for your product, then examine the impact of Design Change -- and the importance of Change Control -- on production and process activities. Throughout each exercise, you'll focus on documenting your actions and decisions to the satisfaction of an FDA or third-party auditor.

 

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"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: Internationally recognized Design Control specialist;

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

 

Denise Dion, former FDA investigator and Design Control Class 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) and a member of FDA's Design Control Inspections Strategy team.

 

For her EduQuest clients, Denise provides regulatory guidance and regularly conducts facility audits 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. She is the author of the EduQuest Advisory on “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 Quality Systems", among others.

 

Here's what other students say about this course

and the course instructor:

 

"Denise was fantastic. I wish I could bring this class back to my team, with Denise to explain it!" (N.H., May 2014)

 

"The class offered by EduQuest was by far the best class we ever attended. The instructor, Denise Dion, was such a good teacher. She explained the regulations at my level of understanding and was able to answer every question with 'real world' situations. She also met with my team after class to answer specific questions. We absolutely would go to another EduQuest FDA compliance course." (S.G., April 2012)

 

"These are great training courses which have already helped me with my job. Thanks very much!" (E.C., May 2015)

 

"The experience that Denise shared with great knowledge was great. The class was very informative. I truly enjoyed it." (N.S., November 2015)

“An incredible, in-depth yet concise view of all of design control. Well presented, interesting examples.” (G.B., February 2015)

 “It was great to get facts about design control as opposed to someone’s interpretation.” (R.F., February 2015)

 “Facilitator answered every question, explained real examples, and was very matter of fact. No conflicting information.” (D.G., February 2015)

"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." (October 2012)

 

"The perspective was directly from ex-FDA, not just 'industry experts'. Details were provided on [FDA] expectations and clarification of requirements vs. specifications." (D.T., May 2014)

 

"I really enjoyed the class. Denise is a very good speaker and does a great job at providing examples." (October 2012)

 

"Overall, a masterful job. The instructor is clearly a master on these topics and communicates her knowledge and experience well." (J.G., April 2012)

 

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

 

 

Latest Schedule of Course Dates:

 

Design Control for Medical Devices:

Meeting FDA's 21 CFR 820.30 Rules for Quality Design and Manufacturing

Wednesday through Thursday, September 20-21, 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 Medical Device Design Control course is $1,995, 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 your management.

 

Save with a Team Registration:

Register 5 students for the tuition 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 Design Control course with the two-day QSR Compliance Basics course (offered immediately prior, on Monday and Tuesday).

 

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