Jeff Priem & Associates, LLC is a Quality and Compliance consulting firm serving the worldwide healthcare regulated industries.
We provide Consultant subject matter expertise and guidance to the biotechnology, pharmaceutical, and medical device industries on GxP compliance, product development, technology transfer, Information Technology, and regulatory / CMC readiness issues and activities.
- Loaned Executive Interim Head-of-Quality
- Compliance & PAI Readiness
- Technology Transfer Strategy & QbD
- Compliance Management System Development & Assessment
- Quality Program Design, Implementation, Performance Management: Lean QSM
- Risk Management Program Design, Implementation, Training, Facilitation
- Process & IT Validation Strategy, Implementation & Assessment
- SDLC program optimization
Jeff Priem is the Owner and Principal Consultant. Mr. Priem is a results driven systems-thinker with over 20+ years of experience in the FDA-regulated healthcare industries. Working in the quality assurance, compliance, operations, consulting, and engineering capacities; Mr. Priem possesses strong regulatory, product, and process knowledge, training, and facilitation expertise. Mr. Priem serves as subject matter expert on FDA and EU Compliance-related issues as well as on Information Technology, Product / Process Technology Transfer, PAI Readiness, Risk Management, Process Optimization, and Quality System Implementation subjects.