This 2-day course provides intensive coverage of the elements of a corrective and preventive action (CAPA) system. Some primary topics include: the purpose of a CAPA system and how it is integrated throughout a Quality Management System; appropriate data sources and how to coordinate, analyze and manage them; methods for verifying and / or validating actions; how to write good CAPA plans; how risk management is used in conjunction with the CAPA system; and 21 CFR and ISO 13485 requirements.

For more information:  https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y2E000007VMid

Today the news is inundated with stories about cybersecurity compromised businesses, public services, and government operations.  Among those we often hear as being compromised are hospitals and healthcare-related organizations.  When compromises to healthcare organizations do occur, they have frequently shut down a department’s or an entire organization’s operations so that their ability to deliver healthcare and even patient safety can be adversely affected in a severe way.

While advancements in medical technology in recent years have led to great improvements in healthcare delivery, those same technology advancements are also creating new cybersecurity risks that, if not properly mitigated, could produce disastrous effects for healthcare organizations and their patients.  The first step in mitigating the growing cybersecurity risks associated with medical technology is to educate the CE/HTM community.

Attendees of the Medical Device Cybersecurity 101 for HTM Professionals session will have:

• a general understanding of today’s growing cyber threat landscape as well as cybersecurity concepts and terminology
• an appreciation of the medical device cybersecurity risks that exist today
• an understanding of the processes necessary for implementing an effective medical device security risk management program
• a familiarity with regulations as well as appropriate standards and guidance associated with medical device security and how they should be applied
• the ability to integrate medical device cybersecurity effectively into an organization’s other information security processes and the organization’s emergency plan

For more information:  https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y2E000007YvaL

Industrial Sterilization for Medical Devices is a comprehensive 4-day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more. 

Participants will learn how to apply the principles of sterilization and address requirements during product design. Participants will also determine how to select and implement an appropriate sterilization process and how to identify the elements of a successful sterilization validation. Students will participate in the design of process validation for moist heat, ethylene oxide (EO), and radiation sterilization processes and compare and contrast sterilization cycle developments based on product bioburden and those based on combined bioburden/overkill methods.

For more information:  https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y2E000007VMBQ