Quality Management of Electronic Systems in Clinical Trial Investigations: A Comparison of FDA and EMA Guidance

Michael C Redmond

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Description: 

As clinical researchers, we are challenged to fully integrate the management systems needed across functional areas within our electronic systems. Most frequently, the IT group and vendor manage the technology, but software AND process needs to be managed and understood by other cross functional areas when conducting day to day trial activities to support human subject protection and data integrity. This includes pre-study protocol development, vendor and site selection activities, subject safety surveillance, data management, site monitoring, protocol management, project management, and more. 

This webinar presents an overview of the quality management of electronic systems in clinical trials for cross functional teams. The session includes an important comparison of some of the FDA and EMA guidance and regulation, including recent guidance from EMA. This course can be used to conduct training for your teams and to help you plan and conduct a gap analysis of your current quality management system related to all stages of clinical trials.

LEARNING OBJECTIVES 

By attending this interactive session, you will be able to…

·  Identify specific quality systems elements to support the use of electronic systems regarding sponsor, site, and IRB/EC regulatory responsibilities

·  Avoid the most common misconceptions related to use of electronic records

·  Recognize the process of ensuring the use of electronic records supports the predicate rules for sponsors, investigators, and IRBs/ECs

WHO SHOULD ATTEND

This course will be of benefit to anyone working in a GCP regulated or clinical trial environment on global or domestic scale who manages clinical quality management systems (CQMS) at a sponsor, CRO, or site level. This includes personnel in…

*Quality

*Clinical Operations

*Clinical Monitoring

*Other related functions

Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Michael C Redmond, CEO and Lead Consultant, Redmond Worldwide

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.


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