Our staff's expertise covers the entire spectrum of quality and compliance, and including former FDA regulators and state regulators
Dennis Moore, an ex-FDA investigator with 28 years in the regulatory and compliance field, is currently Chief Technical Expert and Managing Partner. Dennis brings 28 years of experience in medical device design, software design validation systems and evaluations, manufacturing software validation including ERP systems and FDA Predicate rules and the 21 CFR Part 11 rules as they apply to device firm’s quality systems. Dennis has extensive experience helping firms achieve compliance to FDA regulation and International Standards regulations. Recent achievements include CE marking a medical device, helping a previously vioaltive firm achieve a no FDA 483 outcome, helping create a Combination Product Quality System; co-authoring a Technical File submission, and achieving ISO 13485:2003 and ISO 9001:2008 certification for a medical device manufacturer.
Anne brings 16 years of hands-on experience in designing and manufacturing medical products. Anne has expertise in quality assurance compliance including developing and auditing quality systems, evaluating robustness of IQ OP PQ validation data, conducting supplier audits, design control and manufacturing processes. Anne has recently assisted several “at FDA Warning Letter risk” clients in achieving a no FDA 483 outcome after her efforts at advisement.
Exceed Revenue and Cost Savings Targets — Continuous Improvement Team Builder Results-oriented, data-driven process change manager who uses sharp analytical skills to lead cross-functional teams to achieve company-wide initiatives. Lean/Six Sigma Green Belt certified, and Project Management Professional certified. Articulate collaborator comfortable interacting with colleagues from every level of an organization.
Carol brings a 20 year experiential PhD level wealth of medical writing talents including: preparing CSRs and sections of clinical summary documents in the New Drug Application (NDA); performs quality control reviews of medical writing documents ensuring adherence to established regulations and client guidelines; Interprets data output and writes clinical and statistical reports; writes investigational drug brochures, and Investigational New Drug (IND) sections (preclinical and previous human experience);writes IND annual reports.
Dannie is ex Director of Compliance for the Los Angeles FDA District. He has written over 1800 Warning Letters. 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
David brings 42 years experience spanning all levels of field services quality and design. David is a skilled quality engineer and field technician. David excels at board design, and troubleshooting evaluation of complex systems incorporating multiple technological disciplines. David is skilled in both PC and Macintosh IT environments. David has multiple patents, and is very senior at box build and breadboard layout along with examination of pc board design.
George Calafactor is a 30-year food, cosmetic, drug, biologic, clinical, and medical device non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator and over 9 years of industrial experience as a biologic, pharmaceutical, and medical device industry quality assurance consultant, regulatory compliance specialist, and ASQ certified quality biomedical auditor.
Extensive architecture, design and development expertise in areas ranging from aircraft visual display firmware to Operating System drivers. Familiar with varied environments, including embedded processors with various constraints, for both Fortune 500 and small companies.
Jeff is Director of RA/QA for Auk. He has assisted both international and domestic medical device and biopharmaceutical companies and clinical laboratories since 1998. Jeff represents projects such as: FDA Warning Letter Remediation Assistance, 510(k) Device Submissions, CE Mark Technical File Assembly, FDA Quality System Audits, ISO 13485 Audits and Consulting, Environmental Monitoring Development and Consultation, Complaint Management Assistance/Remediation, Quality Systems Development, Supplier Audits, Sterility Control /Clean Room SOP Development
Kaiser completed a 29-year career with FDA where he was Director of Mechanics and Materials Science; Associate Director, Clinical Lab Devices; Chief, Clinical Chemistry, Hematology, and Pathology. He had a distinguished career as a clinical regulatory scientist and manager of device and drug evaluations, approvals, reengineering, standards, good manufacturing and quality system applications. He worked with individual and industry organizations in both design and total product life cycle (TPLC) approaches to pre-market applications for medical devices, pharmaceuticals and combination products.
Highly motivated, results driven, Drug Quality System Compliance Consultant who has the technical knowledge, industry experience, and outstanding interpersonal skills needed to work with clients to develop effective quality system solutions.
Rebecca provides regulatory and quality assurance consulting services to FDA- regulated industries. She 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 Ms. Fuller uniquely able to understand the balance between compliance and business objectives. She is a specialist in successful strategic planning in response to FDA Warning Letters to mitigate enforcement action; including the development and implementation of comprehensive systemic corrective action plans. She has proven ability to handle delicate issues such as product recalls, inspections, and interaction with FDA officials.
Twenty eight years of industry experience in Quality and Regulatory Affairs.