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.
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.
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Hurdle the biggest obstacle facing device companies – translating product design into real-world manufacturing conditions
Receive practical, actionable compliance advice straight from the source – former FDA inspectors, rule-makers, and trainers
Hear “lessons learned” by other device companies who have been cited by FDA for deficient or non-existent design controls
Identify best practices for device design control and transfer
See how FDA rules relate to ISO, GHTF, and ICH standards – and save time and money with an integrated compliance blueprint
Learn to quickly capture feedback – both internal and external – to fine-tune your quality system and avoid product seizures and recalls
Compare notes with other device manufacturers who face challenges similar to yours
Receive a Certificate of Completion to document your training to senior management and FDA inspectors
EduQuest 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.
Design Control for Medical Devices:
Meeting FDA's 21 CFR 820.30 Rules for Quality Design and Manufacturing
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 Does FDA Require Design Controls?
FDA’s major areas of concern
CDRH’s cradle-to-grave vision: The Total Product Life Cycle
Design control as part of the Quality System Regulation (QSR)
FDA’s definition of key design terminology
FDA Guidance for Design Control
Defining a “substantially equivalent” production unit
Understanding difference between a deviation vs. nonconformance
Understanding difference between project design vs. product design
How international standards relate to FDA’s expectations
Design and Development Planning – 21 CFR 820.30 (b)
Implementing top-level design control procedures
Elements of the General Development (GDP)
Best practices in design planning
Design Review – 21 CFR 820.30 (e)
Types of review
Proven design review methods
Design Input – 21 CFR 820.30 (c)
Understanding inputs vs. outputs
Typical input documents
Using FDA recognized standards and guidance
Important of Human Factor considerations
Good and bad examples of requirements
Design Output– 21 CFR 820.30 (d)
Process controls outputs
Other final output documents
Conducting design output review
Design Verification– 21 CFR 820.30 (f)
Understanding difference between verification vs. validation
Elements of a test protocol
What FDA looks for in test reports
What if the design fails V&V?
Design Validation– 21 CFR 820.30 (g)
How FDA defines validation
Key validation documents and methods
Conducting design validation review
Design Change – 21 CFR 820.30 (i)
Developing a change control policy
Role of planned, temporary changes
Identifying all areas impacted by change
Conducting re-verification and re-validation
Design Transfer to Manufacturing– 21 CFR 820.30 (h)
Integrating manufacturing considerations into design
Key design transfer documents
Developing a manufacturing/transfer plan
Proven design transfer methods
Lessons learned in Design Transfer
Impacts on tooling and components
Conducting design transfer review
Importance of process control review
Design History File (DHFs) – 21 CFR 820.30 (j)
FDA requirements for design history
Responsibilities of team leaders
Relationship between the DHF and the Device Master Record (DMR)
Creating a traceable DHF index
Practical suggestions maintaining compliance
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.
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, May 2011)
Denise Dion, EduQuest
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.
"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)
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).
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.
For sleeping room reservations, book your room online at the Hilton Garden Inn or call +1 (240) 566-1500.
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.
This course can be delivered directly at your facility, when and where convenient for you and your colleagues. For details, email EduQuest.
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.
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.
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.
EduQuest: EDUcation: QUality Engineering, Science and Technology www.EduQuest.net +1 (301) 874-6031