2008-Present: Auk Technical Services

Compliance Director


Dannie brings expertise in the following:

  • 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

  • Due Diligence Audits – to support strategic mergers and acquisitions

  • 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

  • System and Process Validation or Qualification – including programmatic assistance, computer system validation, and specific validation/qualification activities

  • Scientific and Technical Assistance – resolution of complex problems including a review program for data integrity, as well as other significant scientific and technical challenges

  • Systems Evaluation – including R&D manufacturing systems assessments, as well as reviews and recommendations for quality control/quality assurance systems

  • Facilities Design and Validation – including a full complement of capabilities from development of requirements to auditing during construction and installation

  • Training – including programs to address compliance and regulatory affairs, as well as custom programs to meet specific requirements

  • 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

  • FDA

  • Medical Devices

  • Quality Auditing

  • Pharmaceuticals

  • Regulatory Submissions

  • Regulatory Requirements

  • Civil Litigation

  • CAPA

  • Regulatory Affairs

  • FDA Remediation

Dannie also has expertise in:

  • FDA Compliance

  • Due Diligence

  • 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

Dannie Rowland

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