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
Receive world-class Quality Systems training
direct from former FDA device officials and industry advisors
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