Who We Are

We bring over 100 years of management and product experience ranging from:

Medical devices to pharmaceutical products
Disposables to capitol equipment
Electronics to chemicals and plastics
Product design/development through manufacturing

Sequitur Associates--The Value of Experience...........

John Dellinger-- Regulatory, Clinical, & Quality Assurance Management

Paul T. Gilmore--New Product Design/Development, Continuous Process Improvement, ISO, Business Process Re-engineering

Sheila Pickering--Regulatory approval process, planning and implementation of quality systems, clinical research, due diligence.

Vincent Brannigan--Regulatory Law, Product Design Risk Analysis

Roger H. Schneider--Software Systems, Regulatory Affairs, Product Design, Imaging Applications

Margaret Matheson--Multimedia, Technical Writing, Project Management

Robert Burton--Pharmaceuticals, vendor and contractor quality auditing, preparation of CMCs, 510 (k)s and Drug Master Files.

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John Dellinger--President

Extensive experience as a device industry change agent in Manufacturing, Quality Assurance, Clinical Trials and Regulatory Affairs.

Corporate Director, Quality Assurance and Regulatory Compliance for a Fortune 500 company.
Hands-on coordination and support during discovery and correction phase of FDA and consent decree actions.
Conceived, implemented, and directed corporate-wide regulatory compliance program, applied lessons learned across an internationally based corporation. One of the primary tools for cultural change within corporation.
Headed Regulatory, Clinical, and Quality activities for a major designer and manufacturer of software driven medical devices.
Chaired various committees at NEMA. Participated in AIUM and HIMA. Published and presented at AIUM, NEMA, and HIMA.
Worked closely with FDA to assure industry's voice has been heard. Invited by FDA to participate as one of 5 delegates representing US interests in the development of ISO standards in Paris.
ASQC certified QAE and an ISO lead auditor.

 

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Sheila Pickering , Ph.D.

 

 Regulatory Approval Process

 

· Preparation of 5l0(k) Notifications; Investigational Device Exemptions (IDEs); Pre-market Approval (PMA) applications, Export Approvals, and European Community Medical Device Directives (A1MDD and MDD) documentation for CE marking

· Establishing effective communication between clients and FDA  and/or other regulatory bodies, and assisting with tasks such as:

 

defining product submission requirements	advisory panel meeting preparation
arranging effective pre-submission meetings	labeling and post approval negotiations
responding to FDA requests for additional information	participation in industry sponsored regulatory initiatives
submission of reports

 

· Strategic regulatory analysis and risk assessment for long range business planning to determine the most efficient and cost effective path to market and to assure consistency with Research & Development, Marketing, Manufacturing, and other functions and activities within the organization.

 Planning and Implementation of Quality Systems
 

· Developing a single quality system which achieves con~pl~ance with GMP, as well as ISO 9000 requirements and also meets the particular needs of the company's products, business objectives, and company culture.

· Performance of combined GMP/ISO audits for purposes of quality systems planning gap analysis, preparation for registrar certification audit, or supplier evaluation and qualification

· Assist in implementing combined GMP/ ISO quality systems:
 
 

System structure and cross-functional links	Personnel training
Documentation (quality manual, SOPs, work instructions)	Selection of ISO Registrar and AlMDD or MDD Notified Body

 

Clinical Research
 

· Design clinical trial study protocols to ensure adequate scient:ific support for intended uses and other labeling claims, as well as the incorporation of clinical outcomes endpoints.

· Structure clinical trials to ensure accurate and complete data collection, comprehensive investigator training, and study monitoring procedures in compliance with FDA bioresearch monitoring regulations as well as the EN 520 standard

· Design post-market clinical smdies to assure compliance with post-marketing surveillance provisions, device tracking regulations and the EC directives vigilance requirements

Due Diligence
 

· Assessment of medical device companies to determine status as to strength of product approval activity and compliance with requirements for quality systems

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Paul T. Gilmore, Ph.D.

 

Took a leadership role in the introduction, training and implementation of Total Quality Management at a Fortune 50 company.
Functioned as change agent across entire corporation.
A distinguished track record in managing effective product design and development, including managing the processes used in a high quality and cost-effective manner well integrated into the manufacturing process.
Led a product development organization through the ISO certification process.
Planned and implemented more than 50 new product introductions, successfully factoring in an understanding of customer needs as well as developing business processes amenable to continuous improvement. Carried the process from idea generation through manufacturing.
Experience in reengineering business processes, taking advantage of electronic document management/product data management technologies.
ISO auditor (IRCA,RAB).

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Vincent Brannigan, J.D.

 

Professor Brannigan's primary research and teaching areas are product liability and government regulation of technology, with a special emphasis on the problem of dealing with novel technologies. He has been a consultant on technology and the law to the Office of Technology Assessment and other federal agencies and has assisted numerous local regulatory officials.

Juris Doctor degree from Georgetown University
Member of the Maryland and D.C. Bars
Faculty member at the University of Maryland
Worked at the Consumer Product Safety Commission, the National Fire Prevention and Control Administration and the Center for Fire Research at the National Bureau of Standards.
Authored legal materials for the Open Learning Fire Service Program
Adjunct faculty member at the US Fire Academy

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Roger Schneider

Industry and government consultation regarding new development in medical and radiation technology and imaging.

Creation, submision and facilitation of PMA and 510(K) new product applications and approvals before the FDA.

Design consultation of corporate software engineering programs to be consistent with FDA requirements.

 

Resume'
Summary Curriculum Vitae

Education
Professional Experience
Representative Professional Activities
Academic Affiliations
Awards and Honors
Patent
Publications

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Robert Burton

 

Graduate Pharmacist--Portsmouth College of Technology, United Kingdom
Certified Quality Auditor (CQA)--American Society for Quality Control
Registered Auditor--International Register Certified Auditors

- Product/process development and manufacture of all major pharmaceutical product types for human and veterinary use.

- Development and implementation of quality and regulatory systems for sterile and non-sterile medical devices, including implantables and diagnostics.

- Set-up and documentation of manufacturing, quality assurance and regulatory systems for pharmaceutical products.

- Conceptual design layout of facilities and processes for pharmaceutical production.

- Facility and new product start-up, technology transfer and trouble shooting for pharmaceutical products.

- Manufacturing cost analysis.

- Process validation for sterile and non-sterile pharmaceuticals and medical devices.

- Quality assurance/GMP training and auditing. Vendor and contractor quality auditing.

- Preparation of CMCs, 510 (k)s and Drug Master Files.
 

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Margaret Matheson

 Multimedia
-Authoring, design, programming and usability testing of effective CD-ROM multimedia learning products, targeted to technical and non-technical professions, for in-house/customer use.
-Production management of CD-ROM multimedia programs.

Technical Writing
-Design, authoring, validation/verification testing, and updates of online help for database and technical instrumentation (software and hardware) testing programs
-High volume manual set revisions, including additions and reorganizations.
-Design and generation of marketing-oriented technical notes and scientific journal articles, and technical newsletters.

Project management
-Design and implementation of software test plans and validation/verification testing. Project management of Beta test sites.

Publications
M.J. Matheson, et al. “A Pyrolysis-GC/MS Library for Polymers.” American Laboratory, 24C (1997).
Thomas P. Wampler , John W. Washall, and Margaret J. Matheson.  “Applications of purge-and-trap to      the analysis of beers.”  American Laboratory, 18T (1996).
M.J. Matheson, et al.  “The effect of carbon-black filling on the pyrolysis behavior of natural and synthetic rubbers.”  J. Anal. App. Pyr. 29, 129-136 (1994).
M.J. Matheson, et al. Rubber World, 14, (1996); reprinted from J. Anal. App. Pyr. 29, 129-136 (1994).
M.J. Matheson, et al.  “A Pyrolysis-GC/MS Library for Polymers.”  1994 Pittsburgh Conference, Chicago, Illinois.
G. Eytan, M.J.Matheson, and E. Racker.  “Incorporation of Biologically Active Proteins into Liposomes.”  FEBS Letters, 57, 121-125 (1975).

 

 

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Copyright © 1998 Sequitur Associates
Last modified: 25 Feb 99