Course Dates Upcoming Dates and Locations Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times. There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!
Course Details Objectives Describe the requirements of regulations and standards (FDA, EU Device regulation and ISO 13485) as they relate to document control. Plan and structure a document management system that meets new requirements for EU Technical Documentation Identify software used in QMS documentation and regulation of electronic records and electronic signatures in 21 CFR Part 11 Apply process mapping to documentation practices to articulate process linkages for MDSAP Evaluate best practices in technical writing and Good Documentation Practices Review the basics in documentation, including mandatory and recommended elements for policies, procedures, and instructions Develop a robust change control system linked to your design and risk control activities Describe best practices in preparing for successful outcomes from FDA, notified body and MDSAP audits. Topics Documentation requirements (global regulations and standards) Technical writing, process mapping, and error proofing Electronic records Change control requirements Who Should Attend Recommended for staff members involved in preparing plans, procedures, and instructions as part of a document management system. Virtual Half-Days In-Person Full-Days CEUs 1.5