David Luce Email & Phone Number

Philadelphia, Pa, Us

The following services are offered within the spirit, a priori, clientele, and community of practice: ♦ Regulatory Publishing: Source Area/Submission to all regional and local Health Authorities♦ Business Analysis and Application Upgrades♦ Use Case Development♦ Software Development Lifecycle Management♦ Data Migration♦ Verification/Validation, QA/QC Documentation: IQ/OQ/PQ, FRS, UAT, Executive Summary♦ ICH, IEEE, ISPE, CMMI, GxP and 17 years experience in application and process support♦ Document/Records Mgt (Trial Master File, Metadata, Archival and Retention Policies)♦ Clinical Trial Site Mgt, IRB/IEC and CRO Support♦ Pharmacovigilance Application and Process Support - Adverse Event Reporting System (AERS)♦ In-licensing/Out-licensing Support - SLA and Business Process♦ Risk Mitigation: Disaster Recovery/Business Continuity♦ Virtualization Imaging♦ Business Process Change and Modeling: Balanced Scorecard♦ Regulatory Response Team - CAPA Support♦ Corporate Training - user friendly and/or technical♦ Global Enterprise Liaison Services State Department, FDA, EMA Consulates: Brazil, Denmark, Germany, Ireland, Italy, Norway, Portugal, United Kingdom Secretary of State John Kerry during the Hillary Rodham Clinton Primary in Pennsylvania

Responsibilities included XML authoring (DTD, XSD, style guides), regulatory publishing, document management and CRM support to United States medical writers, health care providers and consumer client base.

Responsibilities included the support of regulatory publishing, document management, application verification/validation, SDLC mgt., project management, data migration, Pharmacovigilance support (E2B, AERS), standards development (PDF/A, iECM, metadata management, Dublin Core, IEEE, ISO, ISPE, GMP, 21 CFR 11, etc.), vendor auditing and training for SPRI, global subsidiaries, health authorities (FDA, EMEA), licensed partners, vendors and SDO partners.

Responsibilities included the support of regulatory publishing, document management, application verification/validation, SDLC mgt., project management and training for top 20 Pharmaceutical client base in Chicago, New Jersey and Pennsylvania.

Responsibilities included the development of the Windows and RDC/EDC client image, testing, site implementation, training and support. The primary investigating physician client base was in the United States and globally including subsidiaries in Brussels, Costa Rica and Helsinki.

Biotechnology And Computer Sciences, 3.0

Business Management

School Of Pharmacy, Quality Assurance/Regulatory Affairs