Biomedical Technology - Quality Systems and Regulatory (ISO/FDA)

Medical device and other biomedical and food producing organizations must comply with a wide range of laws and regulations in order to sell to customers throughout the world. You can learn how extensive these myriad rules are, and how quality systems can be designed to make sure that compliance is achieved.

Current On-Campus Classes Can Be Taught at Your Company!

Fundamentals of Internal/ISO and FDA Audit Preparation
Designed as both an introduction as well as a refresher for all personnel involved in the FDA and ISO certification process, this course is an opportunity to compare your internal audit system with compliance expectations. Included is a summary of the types of FDA inspections and different outcomes, along with tools and knowledge needed to assure that your quality system conforms to the QSR.

Principles of cGMP Biomedial Operations
Find out how your Quality System can help you avoid common cGMP citations and actually pay for itself. Discover which style and format options work for successful Quality Systems. Activities will help you practice skills - communication, team building, generation of documents, training and analysis - needed to create a Quality System.

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Customized Classes (call for more information)

• Blueprint Reading
• Essentials of Risk Management
• Process Validation
• Working in a Regulated Environment
• Risk Management & FMEA
• Creativity & Innovation for the Life Sciences