Lee Kentner

QA, Compliance, & Manufacturing Consulting

Lee Kentner is the owner of and principal consultant for Compliance Services & Solutions LLC.  Lee has over 25 years of diverse experience in both Quality and Manufacturing Operations in the pharmaceutical and biopharmaceutical industries encompassing all major dosage forms.  He is also experienced

in all phases of drug development through ongoing commercialization of product in both the US and EU.  Lee has extensive experience with contract service providers (CMOs, CROs, etc.) as well as first-hand responsibility at corporate and site levels. 

Lee held numerous positions of increasing responsibility in the industry.  Most recently he was Vice President World Wide QA for GPC Biotech.  Previously he was Assistant VP Vaccine Operations for Wyeth Pharmaceuticals.  He also held Senior Director/Director level positions with Wyeth, Aventis, and Fisons Pharmaceuticals. 

Business Approach

• Customized, practical solutions based on balancing compliance risk associated
        with the phase of the product, cost, and timeline objectives
• Integrity in all dealings
• Working in a spirit of partnership and collaboration

Key Services include

• CMO and CRO selection and qualification
• Quality System design and SOP implementation
• GXP auditing and follow up
• Internal GXP assessments
• Pre-approval inspection preparation
• Detailed document review (Protocols, Reports, Batch records, etc.)
• Remediation of FDA 483 and EMEA inspection observations
• Interim Leadership