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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 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
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 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.
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)
President and Co-Founder,
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.
"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)
Design Control for Medical Devices:
Meeting FDA's 21 CFR 820.30 Rules for Quality Design and Manufacturing
This course can be delivered directly at your facility, when and where convenient for you and your colleagues. For details, email EduQuest.
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