The experts from the FDA Compliance Boot Camp now offer two intensive medical device training courses.
Experts from the FDA say approximately 44% of device recalls are due to faulty design. Recalls are expensive, embarrassing, and often lead to more serious financial consequences – not only from the FDA but also from courts and unhappy shareholders.
To survive in today's tough economy and ultra-competitive medical device market, you need a quality system that works from the get-go – from the start of product design, continuing through component selection, manufacturing, use and disposal.
Register now for Medical Device Quality & Compliance Institute 2013: Quality Systems and Design Control Training – two courses presented by EduQuest in cooperation with FDAnews that are offered separately or as an integrated three-and-a-half-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 and implement design controls, then transfer product design to manufacturing operations.
With three-and-a-half days of intensive training you'll walk away with the compliance guidance and insight you need to meet FDA standards with confidence.
Learn straight from the source – former FDA inspectors, rulemakers, and trainers from the global consulting team of EduQuest, headquartered near Washington, D.C. Through plain-English instruction, detailed course materials and interactive exercises that reinforce the lessons (not to mention make the classroom more fun and interesting), you will learn to cost-effectively comply with the FDA's QSR rules and related international standards.
Specifically targeted to device manufacturers and suppliers, the institute gives you a thorough understanding of the massive 21 CFR 820 Quality Systems 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 is there.
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.
Course #1 — QSR Compliance Basics: Complying with the FDA's Medical Device 21 CFR 820 Quality Systems Regulation (12 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 day-and-a-half 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.
Course #2 — Design Control 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 is relentless pressure from both the FDA and Congress to improve device design control and manufacturing.
By registering for the Design Control and Transfer course, you will learn how the FDA expects you to develop, implement, and manage design control. You will 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 will learn how the FDA's design control rules relate to product quality standards established in ISO 9001:2008 and ISO 13485.
Medical Device Quality & Compliance Institute is offered at the following location:
April 30 – May 3, 2013
Hilton Garden Inn, Frederick
7226 Corporate Court
Frederick, Md. 21703
(Please mention discount code: QUEST2)
Reservation cut-off date: April 8, 2013
Three Easy Ways to Register
Please mention priority code 13314 when ordering.
- Enroll online
- Call toll free 888.838.5578 (inside the U.S.) or 703.538.7600
Use your American Express, Visa, or MasterCard
- Mail your check to: FDAnews, 300 N. Washington St., Suite 200, Falls Church, Va. 22046-3431.
Download the brochure for more information.