David Kostenberg
Sr Quality Assurance Specialist at Dalton Pharma Services
Based in Canada
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Seniority
Staff
Department
Information Technology
Location
Canada
Industry
Pharmaceutical Manufacturing
Company size
155
Contact information
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d•••••••@dalton.com
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Background
About David Kostenberg
Over 25 years of managerial and consulting experience in pharmaceutical and bio/pharmaceutical industry with focus in Quality issues. • Consulting services on GMP-compliant quality issues in development, manufacturing and submission of New Drug Substances and Drug Products. • Establishing and Managing of GMP-compliant Quality System, including Quality documentation, Compliance issues, Annual Product Reviews, Stability Program, and Personnel Training. • Establishing and monitoring ICH-compliant Stability Programs, preparing Stability Protocols, Trend Analyses, and Summary Stability Reports. • Expert knowledge in Analytical Method Development & Validation, Quality Control procedures for APIs and Drug Products.
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