8 sessions, Wednesday evenings from 6 – 9 PM
Class Starts: March 21, 2018
Class Ends: April 25, 2018
Cost: $480 MNASQ Member, $580 Non-Member
Class Registration Deadline: March 7, 2018
Class Covers Exam Body of Knowledge: Auditing Fundamentals, Auditing & Inspection Processes, Regulatory Requirements, Quality System Regulations, Biomedical Knowledge, Quality Tools & Techniques, and Biomedical Standards.
The Certified Biomedical Auditor is a professional who understands the principles of standards, regulations, directives and guidance for auditing a biomedical system while using various tools and techniques to examine, question, evaluate and report on that system’s adequacy and deficiencies. A biomedical auditor analyzes all elements of the system and reports on how well it adheres to the criteria for management and control of process safety. A biomedical auditor analyzes all elements of the system and reports on how well it adheres to the criteria for management and control of medical device related processes for 21 CFR 820 and ISO 13485 regulations. Other geographies such as Canada, Brazil and Japan are also discussed in addition to bio compatibility and Sterilization requirements.
CBA is a good progression for certified quality auditors working for medical device manufacturers, contract manufacturing and testing facilities. Quality professionals working for the medical device industry at all levels ranging from supplier auditors, compliance specialists to facility managers in the medical device industry will benefit from taking this class.
Tuition does not include the course texts. Please purchase the primer and solution text from the Quality Council of Indiana. The electronic exam CD while helpful is not required.
GUARANTEE FOR EVERY CLASS: If you attend the certification refresher class and don’t pass the exam, you can re-take the class free of charge.