President, Extended Clinical Services, LLC
Consulting with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of computerized project scheduling, strategic planning, Quality Management and Computer Systems Validation, Managed large-scale clinical projects including development of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs.
Taught numerous public and in-house courses on various aspects of Computer Systems Validation and Auditing Computer Systems.
Assisted in the development and validation of numerous computerized systems in all GxP environments.
Assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management and compliance to regulations.
Familiar with the various aspects of Computerized Systems and CFR 21, Part 11,FDA Guidelines for Computers, ICH-GCP, and GxPs.
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