Joe and has been involved in Computer Validation and software development since
1981.  His efforts, since 1994, have been focused on leading a nationally-recognized,
Computer Validation and 21 CFR Part 11 consulting firm.  Joe has trained thousands
of Pharmaceutical personnel on Part 11 assessment, Computer Validation, and
testing. He also participates in regular meetings with the FDA to discuss advanced
Computing Technologies and their input on validation.

He earned a Master of Science degree in Technology Management from the
University of Pennsylvania and a Bachelor of Science degree in Commerce and
Engineering from Drexel University. He has received certifications in Regulatory
Affairs (RAC), IS Project Management (PMLG), Client Server Technology (Penn
State), Mercury Test Suite, ISO 9000 Lead Assessor (BSI), and International
Business (Drexel).

After graduation, Joe’s early assignments included developing factory floor Supervisory
Control and Data Acquisition (SCADA) Systems for British Petroleum and Hewlett-Packard.
Since 1991, his validation initiatives have included: remote clinical data acquisition, clinical
trial management, document imaging, indexing and management, adverse event reporting,
toxicology, laboratory data acquisition, chromatography, LIMS, clinical supply stock
management, regulatory publishing, medical devices, and CRO systems development
quality assurance.

He has published papers and delivered speeches on: Validation Issues for Electronic
Signatures, Hazards Analysis, Ensuring Proper Testing of Web-Based Regulated Applications
and Y2K testing.

Joe enjoys coaching his employees to be the best they can be.