Biomedical Consortium 2023 Event Planning
February - Understanding Medical Device Quality Systems - This class will be particularly beneficial for those who typically only get to work within a small part of their company’s quality management system. But those who have been in the industry for a long time in many roles, may also be surprised by what they hear and learn in this class as the instructor provides a clearer view of the entire system. Sign up now!
March - QMS Risk – Risk is alive and well in all your processes in a regulated environment. This is an opportunity for you to bring your questions about risk in training, documentation, approvals, change control, etc.
April - EU MDR – We have proposed extensions based on the device's Class. New or updated guidance and standards are being released all the time. Come get your questions answered about the various scenarios that may impact your regulatory compliance strategy.
May - Part 11 & Data Integrity – Part 11 compliant systems must have security features that limit user access and their privileges. Is compliance to Part 11 a mysterious as some make it?
Data integrity is the overall accuracy, completeness, and consistency of data. It also refers to the safety of data regarding regulatory compliance and security. What do these actually mean to those in a regulated environment?
Come get your questions answered on both of these topics
June - The QMS for Combination Products – How does your Quality Management System need to support your manufacture of combination products? Do you have to have two? What is required to support both products? Come get your questions answered.
August - Better Presentation Skills: The Art of Persuasion - Often, nothing strikes more terror into the hearts of otherwise competent professionals as being asked to present information to an audience. The challenge of effectively presenting information is about more than just being to stand in front of a room and speak clearly. It begins like most endeavors with planning and preparation.
September - FDA Event – Content still under construction.