Dan Moskowitz

Background

About Dan Moskowitz

Dan has 15+ combined years of experience within the FDA and drug industry, beginning in 1994 when Dan joined the FDA Seattle District Lab as an analytical drug chemist. Dan’s areas of focus included sample analysis (NDA method validation, routine surveillance, and USP testing) and performing NDA/ANDA pre-approval audits (both in support of the L.A. District and international inspection cadre). Areas of expertise include the evaluation of lab quality systems, lab documentation practices, sample/data handling controls, material test records review, analytical method validation review, spreadsheet validation, Part 11 compliance, and OOS systems review. Within industry, Dan has held positions in QA, validation, and project management. As a senior QA Specialist at GlaxoSmithKline Biologicals (formerly ID Biomedical) in Quebec, Dan was responsible for performing GMP compliance audits within QC, IT, and Materials Management to support PAI readiness. Additionally, he was primarily responsible for quality review of validation protocols in support of the QC laboratory. As a project manager at GSK, Dan supported the roll-out of the SAP enterprise resource planning software platform, which involved the re-engineering of core logistics, materials & spare parts management, and material release workflows. Dan’s most recent industry position was as the Validation Manager at CMC Biologics (formerly ICOS), where he supported commissioning and qualification of utility, processing, and analytical laboratory systems. While at CMC, Dan participated in the build-out, commissioning, and qualification of a GMP manufacturing area utilizing disposable technology. As a new consultant with JYA (2011), Dan looks forward to engineering robust, compliant solutions for laboratory testing, validation, and quality systems. He enjoys the challenge of workflow analysis/optimization, and strives to design quality into GMP processes to support product quality and patient safety. Specialties: Inspections and Audits – • Mock PAI audits • Gap Analysis • Audit Response & Remediation • 21 CFR Part 11 Compliance Laboratory Analytical – • Laboratory Instrument Qualification • Computerized System Security & Data Management • Analytical Method Validation Validation • Validation Master Plan(s) • Validation Scheduling & Project Management • Validation Summary Reporting Product Types • Small Molecules • Sterile Injectables • Vaccines