The Emergency Use Authorization (EUA) authority permits FDA to assist strengthen the nation’s public health protections against CBRN threats by facilitating the supply and use of MCMs required throughout public health emergencies.
The webinar will help in determining your eligibility while applying for the EUA and will cover the following topics:
·The pre-EUA process
·Diagnostics for a new disease
·Drugs: new, repurposed and off-label use of approved drugs
·Biologics: Vaccines, antibody and cellular therapies
·Special release of products by FDA
Who Should Attend:
·Supervisors, Managers in Operational Management and Regulatory affairs
·Project management personnel
·Senior management executives (CEO, COO, CFO, etc)
·Manufacturing managers, supervisors & personnel
·Crisis managers, disaster management and business continuity management personnel
·People investing in FDA-regulated product development projects
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Dr. Michael C. Redmond, PhD, is a certified project manager, PMP, has two master certifications in business continuity/disaster recovery MBCP and FBCI and is certified in emergency management. She is active in cyber security and holds multiple ISO certifications (ISO/IEC 27001 Information Security Management, ISO/IEC 27032 Lead Cyber Security Manger, ISO/IEC 27035 Security Incident Response, ISO/IEC 22301 Business Continuity Management Systems, ISO/IEC 21500 Project Management, and ISO/IEC 41001 Environmental Management). She is an international consultant, speaker and published author.
Michael's MBA in Risk Management included courses in Information Security and Risk Management for Medical Devices and Healthcare. Michael is certified as a Senior Lead Manager in Information Security for Healthcare ISO 27999.As a practitioner, she has been implementing ISO 27999 and ISO 14971 for over 10 years for clients.
Her past experience includes 13 years as a senior manager with Deloitte, KPMG and Chubb in the areas of: compliance, crisis management, business continuity, disaster recovery, emergency management, internal audit/ gap analysis. She was a business continuity/disaster recovery manager with the Bank of New York. She consults for clients in diverse industries such as banking, manufacturing, pharmaceutical, hospitals, government agencies, colleges and universities, law firms, and media.
Dr. Redmond spent 4 years on active duty with the army and 18 1/2 years as National Guard and Reserve before retiring as a major. She is a graduate of Command & General Staff College (Fort Leavenworth), attended civil affairs courses at the US Army JFK School of Special Warfare and is Hazmat trained and DOD certified. The White House honored Dr. Redmond at a luncheon as one of the Top Women in Her Field of Business Continuity.