2008-Present: Auk Technical Services
Compliance Director
Dannie brings expertise in the following:
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FDA-Related Services – including document preparation/reviews, audits and reviews, compliance problem resolution, training, regulatory affairs strategic assistance, preparation and/or review of regulatory filings, and other special services specific to our clients’ needs
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Due Diligence Audits – to support strategic mergers and acquisitions
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Quality Assurance and Controls – including evaluation of written procedures and standard operating procedures, development of laboratory systems and specifications, corporate oversight programs review and enhancement, and more
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System and Process Validation or Qualification – including programmatic assistance, computer system validation, and specific validation/qualification activities
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Scientific and Technical Assistance – resolution of complex problems including a review program for data integrity, as well as other significant scientific and technical challenges
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Systems Evaluation – including R&D manufacturing systems assessments, as well as reviews and recommendations for quality control/quality assurance systems
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Facilities Design and Validation – including a full complement of capabilities from development of requirements to auditing during construction and installation
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Training – including programs to address compliance and regulatory affairs, as well as custom programs to meet specific requirements
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Support Services for Law Firms – including provision of expert testimony on FDA policies, procedures, and precedent to assist with product liability, patent, or exclusivity-related litigation
Prior Experience
Senior Compliance Officer and Drug and Device Specialist FDA
1974 – 2008 (34 years) Boston and Los Angeles District
Served as Senior Compliance Officer and Pharmaceutical and Medical Device Specialist conducting complex and compliance audits of a wide variety of pharmaceutical and medical device facilities. Served as Acting Director
Senior Compliance Officer and Acting Director of Compliance
US Food and Drug Administration 1974 – 2008 (34 years) Skills Top Skills
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FDA
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Medical Devices
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Quality Auditing
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Pharmaceuticals
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Regulatory Submissions
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Regulatory Requirements
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Civil Litigation
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CAPA
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Regulatory Affairs
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FDA Remediation
Dannie also has expertise in:
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FDA Compliance
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Due Diligence
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Combination Products
Education:
University of Massachusettes and Mass College Pharmacy
Bachelor of Applied Science (B.A.Sc.) and Graduate Studies in Pharmacy and Regulatory Law,Graduate Studies in Pharmacy Sciences. Alpha Nu Omega Honor Society