Bettina Kaplan

Head of Quality Assurance Services


Bettina Kaplan

Bettina is a seasoned Pharmaceutical Quality Assurance and Compliance professional with a BS in Chemistry from Steven’s Institute of Technology and various industry certifications in Quality Assurance and Compliance Practices. Bettina has over 30 years of experience in Quality Control, Quality Assurance (R & D, Manufacturing, Quality Systems, Supplier Management, Quality Management and Corporate Quality) and Compliance with expertise in remediating and building robust and effective Quality Systems that are fit for the organization’s size and scope.

Her experience has been in Pharma, OTC, Nutritional, Combination Products, Bio-Pharmaceuticals, Contract Manufacturing and Packaging and APIs. Bettina has held positions of increasing responsibility at Schering-Plough, Thompson Medical Company, Hoffman-LaRoche, Purdue, Sharp Packaging, and Sandoz. Bettina has worked with a wide variety of dosage forms as follows: Oral Solid Dosage Forms – Tablets, Capsules, Softgels, Film Strips, Topicals, Liquids, Creams, Ointment, Gels, Suspensions, Sterile, Biopharmaceuticals, Aseptic products, Powders, Inhalers, Nutritionals, Aerosols and Combination Products.

Accomplishments include developing an active Quality & Compliance Organization to monitor all activities for R & D and Manufacturing Operations, implementation of best practices for Quality Systems to maintain compliance through effective Change Management. Creation of FDA readiness programs to assure effective and inspection management.

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Core Competencies

  • GxP Quality Management
  • Audit Strategy
  • SOP Development
  • CAPA investigation
  • Quality agreement
  • Quality Metrics
  • Third Party Oversight
  • Plant Operations
  • USA and ROW Exp