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Stop spinning your wheels with nonessential activities that waste time and money! In today's economy, you simply can't afford to play the guessing game.
Register now for Medical Device Compliance Institute 2009: Quality Design Control and Transfer Training — two new courses presented by EduQuest in cooperation with FDAnews offered separately or as an integrated three-day learning package — and learn how to develop a by-the-book quality management program. Leave the guessing to your competitors.
Discover how to overcome one of the biggest obstacles device manufacturers face — how the FDA expects you to develop, implement and manage design control and transfer product design to manufacturing operations. With three days of intensive training, you'll walk away with the compliance guidance and insight you need to meet FDA standards with confidence.
Plus, you'll get real-world, step-by-step compliance information from top medical device and quality and compliance experts. 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 the FDA's QSR rules and related international standards.
Specifically targeted to device manufacturers and suppliers, now you can gain a thorough understanding of the massive 21 CFR 820 Quality System Regulation requirements. Know what it takes to stay in compliance and avoid the risk of your product not getting to market or being removed from the market once it's there!
Save $175 Now: Former FDA Investigators Ready to Give You "Insider Advice" — When You Choose the Three-Day Training Package
Choose one course or both courses to suit your needs and fit your schedule. Following is a list of the courses and learning objectives of each.
#1 — QSR Fundamentals: Complying With the FDA's Medical Device 21 CFR
820 Quality System Regulation (8 Course Hours)
Compliance with the FDA's Quality Systems approach is recognized globally as a prerequisite not only for getting your product on the market but — just as importantly — keeping it there.
The full-day QSR Fundamentals course walks you through the requirements of 21 CFR 820, discusses how the FDA's rules correlate with ISO standards and ICH guidance, and examines current FDA inspection and enforcement priorities.
Evolving Approach to Quality Systems
o Scientific foundations of quality systems
o Key quality system elements according to ISO and the FDA
o Speaking the lingo: important cGMP terms and definitions
to the FDA's Quality Rules for Medical Devices
o Core principles
o Quality and compliance: two sides of the same coin
o Seven FDA-recognized subsystems of your quality system
Approaches to Quality Systems
o Comparison of international standards to FDA expectations
o ISO 9001:2000 quality system requirements
o Relationship to ISO 13485:2003
And much, much more!
#2 — Design
Control and Transfer for Medical Devices: Meeting the FDA's 21 CFR 820.30
Rules for Quality Design and Manufacturing (16 Course Hours)
Then take the next step with the two-day Design Control and Transfer course. 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 the FDA and Congress to improve device design control and manufacturing.
for the Design Control and Transfer course, you learn
how FDA expects you to develop, implement and manage design control.
You also focus on overcoming one of the biggest obstacles that regularly
confounds device companies — accurate and consistent transfer of
product design to actual manufacturing operations. Moreover, you learn
how the FDA's design control rules relate to product quality standards
established in ISO 9001:2000 and ISO 13485.
Does the FDA Require Design Controls?
o The FDA's major areas of concern
o CDRH's cradle-to-grave vision: The Total Product Life Cycle
o Design control as part of the Quality System Regulation (QSR)
o The FDA's definition of key design terminology
FDA's Guidance for Design Controls
o Defining a "substantially equivalent" production unit
o Understanding difference between a deviation and a nonconformance
o Understanding difference between project design and product design
o How international standards relate to the FDA's expectations
and Development Planning — 21 CFR 820.30(b)
o Implementing top-level design control procedures
o Elements of the general development
o Best practices in design planning
an arsenal of compliance knowledge
and rank at the top of your next FDA visit!
Register now for Medical Device Compliance Institute 2009.
three days of hands-on, interactive training!
Course instructors have trained the FDA's own investigators
— and some are former FDA investigators themselves!
Denise Dion is the course leader and a senior regulatory consultant with EduQuest. She spent 18 years with the FDA, including service as the Office of Regulatory Affairs headquarters' authority on medical device inspections. She developed inspection guidance materials and medical device training for other investigators. She also was one of the designers, authors and trainers of the Quality System Inspection Technique.
Martin Browning is a course instructor. A former FDA top official, Martin helped draft the original Part 11 regulations. He and his team have trained hundreds of key FDA and industry personnel. Martin, president and cofounder of EduQuest and2004 IVT Speaker of the Year, capped a 22-year FDA career as a special assistant to the associate commissioner for regulatory affairs. As vice chair of the electronic record and signature working group, he helped draft the original 21 CFR Part 11 regulations. He also served as the chair of the U.S. government's ISO 9000 committee and was a member of the committee that developed the medical device quality system regulation.
Save When You Register for Both Courses!
Register now for both Medical Device Compliance Institute's training courses and save.
Your Compliance Team for Minimal Cost
These courses are designed specifically to help:
Staff can't all attend at once? Our new Medical Device Compliance Institute 2009 is currently offered in three locations during the year, including:
July 20–22, 2009
O'Callaghan Alexander Hotel
Sept. 28–30, 2009
Sheraton St. Paul Woodbury Hotel
Course #1: QSR Fundamentals: Complying with the FDA's Medical Device 21 CFR 820 Quality System Regulation
(8 Course Hours)
Course #2: Design Control & Transfer for Medical Devices: Meeting the FDA's 21 CFR 820.30 Rules for Quality Design and Manufacturing (16 Course Hours)
|Dates and Times||
Monday, July 20, 2009
Tuesday – Wednesday, July 21–22, 2009
8:30 a.m. – 5:30 p.m.
Monday, Sept. 28, 2009
8:30 a.m. – 5:30 p.m.
Tuesday – Wednesday, Sept. 29–30, 2009
8:30 a.m. – 5:30 p.m.
Register NOW for Both Courses and Pay Only $2,795 — A Savings of
Space is limited — Register today!
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