Rebecca Fuller provides regulatory and quality assurance consulting services to FDA-regulated industries. Rebecca F. has combined experience in government service and private industry, having worked as an FDA investigator and as the Director of Regulatory and QA functions for several FDA Regulated businesses. This combination of experience in both government and private industry makes Rebecca F. uniquely able to understand the balance between compliance and business objectives.

 
Accomplishments:
  • Fifteen years of FDA and private industry experience in the assessment, development and management of programs to assure medical device and pharmaceutical quality and compliance.

  • Received a Commendable Service Award from the Commissioner of Food and Drugs for outstanding emergency response, performance, dedication, and initiative in protecting the public from hazardous radioactive medical devices using precedent setting methods.

  • Nominated 1992 FDA Investigator of the year.

  • Awarded the Institute of Validation Technology’s 2002 Industry Recognition Award

  • Lead over 100 audits and inspections of drug, device, biologic, and cosmetic companies and successfully prepared companies for FDA inspections, commercial production, and compliance with US FDA regulations. (Includes PAI preparation audits, Mock FDA GxP audits, fulfilling routine internal audit obligations under contract, and comprehensive GAP analysis audits.)

  • Successful strategic planning in response to FDA Warning Letters to mitigate enforcement action; including the development and implementation of comprehensive systemic corrective action plans. Proven ability to handle delicate issues such as product recalls, inspections, and interaction with FDA officials.

  • Member of executive team responsible for GMP certification required by FDA under consent decree. Lead negotiations between company management and the certification team that ultimately resulted in certification of GMP compliance and successful FDA follow-up inspection.

  • Assisted the Palestinian Ministries of Health in the development of a GMP regulation and enforcement plan for the regulation of pharmaceutical industries in the West Bank of Israel. Provided validation and GMP training to a joint coalition of Palestinian pharmaceutical companies as part of industrial development efforts sponsored by USAID.

  • Development and implementation of numerous risk-based Quality Systems and product development programs for multiple FDA-regulated companies.

  • Author of a comprehensive medical device design control implementation manual used by over 20 US and International medical device companies in developing products and managing product development. Developed multiple design control programs, including one for a drug/device combination product. Participation in design review meetings.

  • Expertise in a wide range of validation types and methods.

  • Participated in compliance reviews to support due diligence efforts for acquisition and merger.

  • Achieved consistently high ratings as a public speaker covering a wide range of topics for the FDA-regulated industry.

Rebecca Fuller

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