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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 |
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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
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Company:
Compliance Services & Solutions LLC.
Cell: (610) 703-1945
Email: GXP_CSS@comcast.net
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