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Dennis Moore has 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 Moore also has experience training drug and device firms in all aspects of device and pharmaceutical manufacturing and 21 CFR 210,211 quality systems. Dennis Moore has extensive experience helping firms achieve compliance to FDA regulation and International Standards regulations. Recent achievements include CE marking a medical device, 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.

Additionally, Dennis M. has extensive experience as a Level II FDA Investigator, California Medical Device and Drug Team Senior Investigator, Sworn Government-POST Certified Criminal Investigator, Lead Trainer, Compliance Officer and company Chief Technical Expert and CEO.

Dennis M. has given numerous web seminars on GMP issues; has traveled the world putting out FDA compliance related fires and authored many documents on quality system inspection, FDA/CA narrative report compilation, drug quality systems and software auditing techniques.

Dennis Moore is a member of RAPS, AAMI and is a former official with the State of California Medical Device Team. Dennis Moore also has RAB certification to the ISO 13485:2003 standard. Dennis M. holds a BA degree in Zoology, with Graduate work in Toxicology and a Sworn POST certified Government Criminal Investigator peace officer badge <retired>.

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AREAS OF KNOWLEDGE 

Quality Assurance:

Integration of ISO 9001, ISO 13485, 21 CFR 820 Quality Systems, GMP/GLP Auditing and training, medical device design control, development and implementation of risk-based quality systems, Process and Design FMECA, complaint management and failure investigation, development of Part 11 and software quality assurance programs, process development and validation, technology transfer and scale-up, process monitoring programs, environmental control and monitoring, development of documentation and change control programs, and development of OOS programs.

Regulatory Affairs:

Management of FDA Pre-Approval and Quality System inspections, corrective action and remediation plans for Warning Letters, FDA 483s and Part 11 compliance, regulatory strategic planning, risk management, 510(k)/PMA submissions, development of CMC sections for NDAs, promotion and labeling of medical devices for FDA compliance, participation in due diligence regulatory reviews.

Manufacturing:

Injection Molding, Extrusion, Electronic Assembly, Software Production Control, Manual and Automated Assembly, Reagent & Media Batch Production, Cell Culturing, Monoclonal Antibody Diagnostic Testing, EIA, Rapid Assay, Protein Purification, Sterility Testing, Endotoxin Testing, Aseptic Filtration, Sterile Filling and terminal sterilization.

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EDUCATION AND TRAINING

San Jose State University. Bachelor of Arts, Biological Sciences,1976 AAMI certified to Quality System Regulation compliance practices/passed AAMI proctored QS Reg. exam associated with course AAMI trained in Design Control Concepts AAMI trained in Process Validation Concepts AAMI trained in Part 11 and Software Auditing Graduate of FDA’s Basic Medical Device Investigation Course QSIT Certified by FDA (proctored exam) ISO 13485:2003 auditor course graduate/passed proctored RAB 13485:2003 certification exam Twenty one years drug compliance experience

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RECENT ACCOMPLISHMENTS

  •   Client firm is inspected by FDA after Mr. Moore’s consultation services, and fully passed the FDA audit, with no significant adverse findings. A full Quality System was created for this class II medical device manufacturer client

  •   Assisted a Finland device firm ,on site, to convince FDA to release an import detention

  •   Client firm successfully integrating web based sales of Rx class II medical device

  •   Created a CMS {Medicare /State of CA Rx-HMDR} quality system for a client

  •   Client firm 510(k) technical file created from 510(k) submission data

  •   Client firm, using Mr. Moore’s consultation services to correct warning letter conditions, passes state of California license inspection.

  •   Created six system drug firm quality system

  •   On staff for www.complianceonline.com, providing webinars on medical device and pharmaceutical compliance subjects

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-        October 2004-Present President and CEO of Auk Technical Services (ATS) ,LTD, Beverly Hills CA, a global medical device consultation organization. As CEO and Technical lead, Mr. Moore leads ATS in offering global services for:

  • training for Quality System Regulation, design control, process design, compliance achievement

  • project planning assistance for drug plant start ups

  • 510(k) submissions

  • IVD compliance

  • software compliance

  • risk management

  • MDD compliance

  • mock GMP/ISO audits

  • preparation of Technical File for product CE Mark

  • submission/registration

  • equipment validation IQ/OQ/PQ

  • sterilization validation

  • HMDR quality system documents and personnel training

  • assistance during FDA and state drug and device government audits

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Aug., 1995 – October 2004 SENIOR FOOD and DRUG INVESTIGATOR Nov., 1984 – Aug., 1995 FOOD and DRUG INVESTIGATOR, Responsibilities and Achievements in prior position

  • Experience with Cardiology Devices, including stent development, graft placement devices, beating heart bypass development. Responsible for approving licensure for Cardiology devices.

  • Responsible for design control compliance evaluation for Cardiology Devices, including stent development, graft placement devices, beating heart bypass development.

  • Responsible for evaluation of clinical data, including cardiology device patient data.

  • Medical device Quality System Regulation inspection, including regulatory decisions; am a fully credentialed FDA Quality System Regulation Medical Device Investigator

  • Quality System Regulation education for medical device manufacturers, including design Control education and auditing of medical device manufacturers. Presentation of training, and preparation of training materials.

  • Evaluation of complaints and MDR issues, regarding medical devices

  • Responsible for implementing interactions between Governmental

  • agencies

  • Experience auditing for compliance radiation therapy planning systems, and mammography systems

  • Required to administer projects, from idea generation to completion, including warning letters and other regulatory functions

  • Involved with current State of California Third Party 510(k) qualified body project

  • Implemented, designed and coded the California Food and Drug Branch web page, seen at http://www.dhs.ca.gov/fdb

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References

Micro Medical Devices Inc.

Created full 21 CR 820 quality system, ISO 13485:2003 quality

system, wrote technical file, assisted firm in their getting CE mark

Firm was audited by FDA 2006, <AUK LTD present during FDA

audit> and obtained letter of closure from Loa Angeles District

Office. FDA now has them noted to be in compliance.

Firm was audited by a Notified Body, and obtained ISO 13485:2003

certification.

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Confidant INC

Durham NC

David Jackson, CEO

Created full 21 CFR 820 quality system, ISO 13485:2003 quality system; Firm was audited by FDA 2006, <AUK LTD present during FDA audit> and obtained letter of closure from Atlanta District Office. FDA now has them noted to be in compliance.

Dennis Moore

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