This one-day program is designed to provide introductory information for those organizations who are considering transitioning from the Aeronautic, Space and Defense industry to the Food & Drug Administration (FDA), Medical Device Manufacturing market. Reviewing essential information necessary to understand and successfully begin the journey to FDA Medical Device approval, this course will examine many of the controls between the AS9100 Standard and FDA Regulations and identify the similarities.
The aerospace industry is focused on developing support and rationale for training related to human factors because it fosters a positive safety culture and it reinforces the concepts related to risk assessment, voluntary reporting, event investigation and peer-to-peer support. This seminar is intended to introduce the skills and knowledge necessary to identify and optimize the factors that affect human performance in maintenance and inspection.
Individuals responsible for quality management system, implementation, and auditing to the AS9100:2016 series of standards for Aviation, Space, and Defense will require an understanding of the requirements for the preparation and execution of the audit process as defined in these revised standards. Management and implementers of AS9100:2016 Rev. D within these organizations must also be aware of what these requirements mean for their company.