Expert Profile
Harry Huss
Chief Compliance Officer,
He is currently Chief Compliance Officer, Touchstone Technologies Silicon Valley; and has held positions as Executive Directive, Brandywine Compliance Consulting; Senior Director Compliance Policy & Program Support Services, Charles River Laboratories; Associate Director of Computer Validation Quality Assurance, Merck & Company; and Regulatory Compliance Manager, SmithKline Beecham.
Harry has a M.S. degree in Clinical Microbiology from Thomas Jefferson University, and B.S. degrees in Biology and Medical Technology from Millersville University and Bryn Mawr respectively. He has provided numerous computer validation and Part 11 presentations at professional meetings, provided computer validation training for the FDA, authored a Master Validation Plan for the FDA National Center for Toxicological Research (NCTR), and published a variety of scientific and regulatory compliance articles. Harry is a member of the Drug Information Association Validation SIAC Core Committee and a member of the Society for Quality Assurance Computer Validation Initiatives Committee (CVIC).
Harry has a M.S. degree in Clinical Microbiology from Thomas Jefferson University, and B.S. degrees in Biology and Medical Technology from Millersville University and Bryn Mawr respectively. He has provided numerous computer validation and Part 11 presentations at professional meetings, provided computer validation training for the FDA, authored a Master Validation Plan for the FDA National Center for Toxicological Research (NCTR), and published a variety of scientific and regulatory compliance articles. Harry is a member of the Drug Information Association Validation SIAC Core Committee and a member of the Society for Quality Assurance Computer Validation Initiatives Committee (CVIC).
Live Training by Harry Huss
This is a course that anyone in a hospital or clinic who might be involved in conducting a clinical trial should take. Even if one is not involved in doing the Risk Management, it would not hurt for them to understand something of what it is in case they observe something going wrong during the research.
Live Session
Tuesday,
June 4, 2013
10:00 AM PDT | 01:00 PM EDT,
Duration:90
This is a course that anyone in a Pharmaceutical Company, CRO, hospital or clinic involved in clinical research should take.
Live Session
Tuesday,
June 18, 2013
10:00 AM PDT | 01:00 PM EDT,
Duration:90
This is a course that anyone in a hospital or clinic who might be involved in conducting a clinical trial should take. If they have never been involved they will learn what one is, if they have done clinical trials it will be useful to put everyone on the same level as far as terms and operations.
Live Session
Wednesday,
July 10, 2013
10:00 AM PDT | 01:00 PM EDT,
Duration:90
Recorded Training by Harry Huss
The comprehensive testing and control of computerized systems if first and foremost a matter of business continuity. The industry is absolutely dependent upon the reliability and accuracy of these systems for daily operations. Short of fire or catastrophic natural disasters, nothing is more disruptive to business continuity than the dreaded phrase, "the system is down".
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.
Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation. Understanding the requirements of Part 11 is critical to compliance with the regulation. Knowledge of regulatory requirements is an exercise in efficiency…both efficiency in project management, and avoidance of non-compliance penalties.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.
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