Summary
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Consultant to medical device and biotechnology companies with
specialization in regulatory affairs. Almost twenty years of
experience developing products and managing projects in the medical
device and biotechnology/pharmaceutical industries. Ten years of
management experience with roles of increasing responsibility from
four people to 100+. Positions held range from CEO to Lead Auditor.
Technical expertise includes 510(k) submissions, CE Marking, ISO
Certification, Sterilization Validation, Silicone
Compounding/Extrusion, and bioreactor scale-up.
Recent Professional Experience
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BSI GROUP, New England
QMS Auditor & Training Instructor, External Resource
9/09-Present
Quality Management System (QMS) auditor and training instructor.
Auditing schemes include CE Marking, CMDCAS, ISO 13485:2003, ISO
14971:2009, ISO 9001:2008, and mock FDA inspections (Level 1 & 2)
using the FDA’s Turbo system.
PACKARD CONSULTING, Windham, VT
Independent Consultant 4/08-Present
Regulatory consulting includes preparing 510(k) submissions, writing
IFUs, preparing risk analysis documentation, submission of FDA
facility establishment licenses, CE Marking, Preparing Technical
Files, and ISO Certification. Specialty management services include
business plan development and strategic planning for start-up
medical device companies. Engineering services include product
development and process validation with extensive experience in
material selection, packaging design and sterilization validation.
Quality System consulting includes offering customized in-house
training programs, creating draft procedures, recommendations for
improvement, coaching of Quality Managers, and preparing regulatory
filings. Quality System Auditing includes performing full Quality
System internal audits, auditing the effectiveness of internal
auditing programs, and performing second-party audits of potential
suppliers on behalf of clients.
CAS MEDICAL SYSTEMS, INC., Branford, CT
Director of Quality Assurance 7/08-9/09
Responsible for management of Corporate Quality System for CASMED in
Branford, CT & Jacksonville, FL. Responsible for FDA inspections,
ISO audits, Lead Auditor for Internal Audit Program, UL Audits, ITS
Audits, 2nd Party (customer & supplier) Audits, management of 15
quality assurance personnel, and assisting the Director of
Regulatory Affairs with 510(k) submissions. Responsible for
developing a supplier quality program and training Sr. Quality
Engineers to eliminate the root cause of warrantee service returns
for non-invasive monitoring equipment. Audited suppliers as part of
device failure analysis and complaint investigations. Developed a
CAPA training program for all employees. Redesigned the software
documentation system for Quality System Records and developed a
training program for all employees. Developed and executed an
internal auditor training program for 6 internal auditors (3 at each
location). Developed a risk management (ISO 14971:2007) training
program for employees in the Jacksonville, FL facility.
CONFORMIS, INC., Burlington, MA
Director of Quality Assurance 1/07-7/08
Responsible for management of Corporate Quality System for ConforMIS
in Foster City, CA and Lexington, MA. Relocated and consolidated
manufacturing operations in Burlington, MA (3 relocations in 12
months). Responsible for FDA inspections, ISO audits, Lead Auditor
for Internal Audit Program, CE Marking, management of quality
assurance personnel, in-house VHP sterilization and microbiology,
and assisting Senior VP of Clinicals and Regulatory Affairs with
510(k) submissions. Transferred ISO Certification and CE
Certificates from KEMA to BSI in first 5 months. Brought sterility
testing in-house, and reduced product release time by a week.
Responsible for supplier quality program involving US and European
suppliers. Transferred packaging, sterilization and microbiology
activities from California to Massachusetts—including purchase of
capital equipment, installation, validation and start-up of new
facility. Directly responsible for obtaining CE Mark of two Class
III orthopedic knee implants in 2007 & 2008.
Z-MEDICA CORPORATION, Wallingford, CT
Director of Regulatory Affairs 4/04-12/06
Project manager for initial installation of the network
infrastructure. Developed and implemented a Corporate Quality
Management System that is ISO 13485:2003 certified from scratch.
Assisted with grant proposals to the Office of Naval Research and
developed a 2nd generation medical device for the company—including
development of new intellectual property. Served as interim VP of
Operations from April 2004 to November 2004, and managed contract
manufacturing operations. Assisted new VP of Operations with
relocation to Wallingford and validated new manufacturing line for
in-house production. Maintained ISO and CE certificates required for
international distribution. Provided regulatory strategy for new
product development, managed biocompatibility testing, and performed
sterilization validation. Prepared and audited 510(k) and Technical
File submissions as required. Transferred ISO Certification and CE
Certificates from SGS to BSI. Responsible for FDA inspections, ISO
audits, Lead Auditor for Internal Audit Program, CE Marking,
outsourced gamma sterilization, packaging/shipping validation, and
environmental monitoring.
MICRO-INVASIVE TECHNOLOGY, INC., Pomfret, CT
CEO/Chairman/Co-Founder 4/03-3/04
Developed and executed strategies for raising capital for
development of the company’s product platform. This process included
establishing technical and financial milestones, budget development,
conducting board meetings, approving policies and providing
direction for the company. In 11 months, the company was
incorporated, a six-member board of directors was recruited, two
patents were issued, a third patent was filed, and development of
the first product was completed. Every project was successfully
completed on-time and under-budget.
SMART DRUG SYSTEMS, INC., Pawcatuck, CT
Independent Consultant & Project Manager 6/00-12/03
Independent consultant performing project management services that
included: vendor selection and contract negotiations, facility
relocation, equipment design, equipment installation, facility
start-up, recruiting, hiring, training, process validation, product
development, process improvement, etc. Project included two trips to
Japan for technology transfer. Inventor of novel silicone chemistry,
micro-scale compounding process, trade secret extrusion and molding
processes, and miniature extrusion equipment for the company’s drug
delivery system.
Operations Management Experience
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UNILEVER-HPC, Clinton, CT
Operations Manager
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TI GROUP AUTOMOTIVE SYSTEMS, Meriden, CT
Production Supervisor
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CYTEC INDUSTRIES, AC MOLDING DIVISION, Wallingford, CT
Production Supervisor
Biochemical Engineering Experience
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WYETH-AYERST RESEARCH, Pearl River, NY
Research Engineer
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ABBOTT LABORATORIES, Columbus, OH
Independent Consultant
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INSTITUTE OF MOLECULAR BIOLOGY, Worcester, MA
Fermentation Engineer
Education
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Training
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3rd Party Qualified as Lead Assessor as per ISO 19011:2002 (BSI –
June 2010)
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CE Marking Training (BSI – January 2010)
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Lead Assessor Training for ISO 9001:2008 with Emphasis on ISO
13485:2003 (BSI – Nov. 2009)
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CMDCAS Training (Accademia Qualitas – October 2009)
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14971:2007 Risk Management Course (BSI – November 2007)
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Corrective & Preventive Action Course (AAMI – October 2006)
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Internal Auditor Training (BSI – May 2006)
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Quality System Requirements (QSR) & Industry Practice Course (AAMI –
March 2006)
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Design Control Requirements & Industry Practice Course (AAMI – June
2005)
