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:

 

 

Meeting FDA's 21 CFR 820.30 Rules

for Quality Design and Manufacturing

 

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

Learn how FDA expects you to develop, implement, and manage Design Controls for your products -- all from globally respected device compliance experts and ex-FDA investigators.

- 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.

 

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 Martin Browning, one of the co-authors of FDA's Quality System Regulation (21 CFR Part 820) and a senior policy-maker and field investigator for FDA for 22 years.

 

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

Why you should attend:

Why trust your training investment with EduQuest?

 

EduQuest is a global team of FDA compliance experts headquartered near Washington, DC. Celebrating more than 20 years 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.

 

"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:

 

"The class offered by EduQuest was by far the best class we ever attended. The instructor 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 the instructor 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. Very good speaker who 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)

 

“Very entertaining instructor...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

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.

 


RETURN TO EDUQUEST CURRENT COURSES SUMMARY PAGE HERE

 

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