Design Control for Medical Devices
Design History Files…Device Master Records…Essential Design Controls. 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, presented globally to hundreds of medical device quality professionals. By registering, you will:
Learn how FDA expects you to develop, implement, and manage design control
Focus on overcoming one of the biggest obstacles that routinely confounds device companies – accurately and consistently transferring product designs to actual manufacturing operations
What’s a DHF and DMR – and more importantly, what FDA inspectors will be looking for when they review them
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 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).
The goal of this course is to give you real-world, step-by-step compliance information. 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.
Why you should attend:
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 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 EduQuest’s QSR Compliance Resource CD with electronic copies of FDA’s latest quality regulations and guidance
Receive a Certificate of Completion to document your training to senior management and FDA inspectors
Design Control for Medical Devices:
Meeting FDA's 21 CFR 820.30 Rules for Quality Design and Manufacturing
Course Curriculum
Day 1: 1:30 p.m. – 5:30 p.m.; Day 2: 8:30 a.m. – 5:30 p.m.; Day 3: 8:30 a.m. – 12:30 p.m.
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)
Verification documents
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
Documentation reminders
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
Who should attend:
This course is designed specifically to help device industry managers, engineers, QA/QC specialists, and regulatory affairs professionals improve their company’s compliance with FDA’s 21 CFR 820 Quality System Regulation. The Design Control course provides further training on FDA’s 21 CFR 820.30 rules for quality design and manufacturing – which also impact product R&D specialists, scientists, medical professionals, and IT and manufacturing engineers.
Denise Dion, EduQuest 18 years as FDA investigator, trainer, and co-editor, FDA Investigations Operation Manual (IOM) |
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”.
“Denise was very obliging and answered all my questions in depth, so I definitely feel more confident in my new role as CAPA specialist. She [also] did an excellent job of explaining good CAPA reporting. ” (Effective and Compliant CAPA Systems course, July 2009, Dublin, Ireland)
“Denise was excellent!” (Design Control for Medical Devices course, March 2011, Anaheim, CA)
“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) |
2012 Course Schedule:
Day 1: 1:30 p.m. – 5:30 p.m.; Day 2: 8:30 a.m. – 5:30 p.m.; Day 3: 8:30 a.m. – 12:30 p.m.
October 17-19, 2012: Hilton Garden Inn Hotel, Frederick Maryland (near Baltimore and Washington, DC). www.frederick.stayhgi.com. Fly into Baltimore-Washington International (BWI) Airport or Washington Dulles International (IAD) Airport, each approximately a 1-hour drive from Frederick.
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, contact ClarenceDanielson@EduQuest.net.
Tuition for the Medical Device Design Control course is $1,995. Immediately before this Medical Device Design Control course, EduQuest offers a 12-hour course on QSR Compliance Basics: Complying with FDA’s Medical Device 21 CFR 820 Quality System Regulation.
Save nearly $500 when you attend both courses. The combined tuition is $3,000, including hands-on training, all course materials, lunch, refreshments, and the opportunity to learn and interact with some of the top FDA compliance experts in the nation.
Class registration is easy. To enroll or get more details:
(download
Registration Form for October 17-19, 2012, course in Frederick, MD)
Or Email Martin at Info@EduQuest.net
Or call +1 (301) 874-6031 between 9 a.m. and 5 p.m. Eastern U.S. Time
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.
Combine this course with the 12-hour QSR Compliance Basics course (offered on Tuesday through Wednesday morning) and save nearly $500 on the combined course tuition.
RETURN TO EDUQUEST CURRENT COURSES SUMMARY PAGE HERE
EduQuest: EDUcation: QUality Engineering, Science and Technology www.EduQuest.net +1 (301) 874-6031