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80227 USA
303-985-7942

Robert V. Packard

Table of contents


Summary            > back to the top

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            > back to the top

 

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            > back to the top

  • UNILEVER-HPC, Clinton, CT
    Operations Manager

  • TI GROUP AUTOMOTIVE SYSTEMS, Meriden, CT
    Production Supervisor

  • CYTEC INDUSTRIES, AC MOLDING DIVISION, Wallingford, CT
    Production Supervisor


Biochemical Engineering Experience            > back to the top

  • WYETH-AYERST RESEARCH, Pearl River, NY
    Research Engineer

  • ABBOTT LABORATORIES, Columbus, OH
    Independent Consultant

  • INSTITUTE OF MOLECULAR BIOLOGY, Worcester, MA
    Fermentation Engineer


Education            > back to the top

  • THE UNIVERSITY OF CONNECTICUT, Storrs, CT
    Bachelor of Science, Chemical Engineering


Training            > back to the top

  • 3rd Party Qualified as Lead Assessor as per ISO 19011:2002 (BSI – June 2010)

  • CE Marking Training (BSI – January 2010)

  • Lead Assessor Training for ISO 9001:2008 with Emphasis on ISO 13485:2003 (BSI – Nov. 2009)

  • CMDCAS Training (Accademia Qualitas – October 2009)

  • 14971:2007 Risk Management Course (BSI – November 2007)

  • Corrective & Preventive Action Course (AAMI – October 2006)

  • Internal Auditor Training (BSI – May 2006)

  • Quality System Requirements (QSR) & Industry Practice Course (AAMI – March 2006)

  • Design Control Requirements & Industry Practice Course (AAMI – June 2005)

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