IQSA Associates - Pamela Marquard

Independent Quality Systems Associates, Inc.

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Pamela Marquard

SUMMARY

I have 20 years of managerial experience, most recently in the Quality Assurance / Regulatory Affairs department of an FDA-regulated manufacturing facility. I directed the development and implementation of a quality system that allowed my employer to successfully complete two FDA pre-approval inspections and to achieve ISO 9001 registration. In addition, I assisted with clinical and non-clinical studies and managed the formatting, organization, and assembly of submissions which led to a 510(k) clearance and a PMA approval. Throughout my career, I have been commended for my organizational and communication skills.

AREAS OF EXPERTISE

Quality Systems

Develop and implement quality systems based on FDA regulations and ISO 9000 standards
Audit quality systems to assess their effectiveness and compliance with standards
Identify quality problems and develop appropriate corrective/preventive actions
Develop and conduct corporate quality training programs

Technical Writing

Prepare written procedures for quality system activities, including manufacturing and quality control activities, validation studies, and stability testing
Develop and document protocols for non-clinical studies as well as clinical trials and prepare written reports of the results of the studies
Format and edit package inserts, operator's manuals, and service manuals for a computer-based cytology sample processing system
Prepare written narrative descriptions of quality system activities as required for FDA submissions
Prepare software validation documentation, including product requirements, software specifications, test case descriptions, and testing scripts; manage validation testing activities

FDA Submissions

Monitor clinical trials of investigational devices
Manage the preparation and assembly of 510(k), PMA, and other documents for submission to the FDA

SIGNIFICANT ACCOMPLISHMENTS

Successfully completed two FDA pre-approval inspections and an ISO 9001 registration audit
Participated in the design, management, and evaluation of clinical trials leading to a successful PMA submission
Edited, organized, and assembled the 4000+ page PMA submission
Audited monitor performance in clinical trials for a successful 510(k) submission

AFFILIATIONS AND CERTIFICATION

American Society for Quality

Certified Quality Auditor - CQA (Certificate Number 10123)
Certified Quality Engineer - CQE (Certificate Number 33712)

Regulatory Affairs Professionals Society

Regulatory Affairs Certified

American Society of Clinical Pathologists

Medical Technologist - MT(ASCP) (Registry Number 082469)
Blood Bank Specialist - SBB (Registry Number 001954)

North Carolina Regulatory Affairs Forum

EMPLOYMENT AND APPOINTMENTS

Feb 1991 - June 1999 AutoCyte, Inc. (formerly Roche Image Analysis Systems, formerly Roche Biomedical Laboratories; now Tripath Imaging, Inc.) Burlington, NC Manager, Quality Assurance

Mar 1980 - Jan 1991 Regional Medical Center at Memphis Memphis, TN Blood Bank Supervisor

Sep 1980 - Jan 1991 University of Tennessee Center for Health Sciences Memphis, TN Instructor, Department of Clinical Laboratory Sciences

CONSULTING / CONTRACTING EXPERIENCE

Mar 1999 - present Independent Quality Systems Auditing, Inc. Ormond Beach, FL Regulatory Compliance Consultant
Assist device manufacturers to develop and implement Quality Systems in compliance with current FDA regulations.

Sept 1999 - present The Technology Integration Group, Inc. Cary, NC Software Validation Specialist
Provide software validation services for medical device manufacturers: Assist with preparation of Product Requirements and Software Requirement Specifications. Write Test Case Specifications and Test Scripts. Manage the testing process. Evaluate testing results.

EDUCATION

MS, Pathology - University of Tennessee Center for Health Sciences
December, 1987 Memphis, TN

BA, Biology - Austin College
May, 1971 Sherman, TX

PUBLICATIONS

"Antiglobulin Testing" and "Other Blood Group Systems", chapters in Quinley E, Immunohematology Principles and Practice, J.B. Lippincott (Philadelphia), 1993.

LANGUAGES

German

REFERENCES

Furnished upon request

ADDITIONAL TRAINING AND EDUCATION

Recurring Conferences

January 26, 2001 May 19, 2000 January 23, 1998	ASQ Food, Drug, and Cosmetic Division, Raleigh NC Annual Workshops - Current Compliance Issues for Medical Devices and Pharmaceuticals
September 18 - 20, 1995 October 4 - 6, 1993	RAPS, Washington DC Annual Conferences

Other Training

March 8 - 9, 2001	RAPS, Rockville MD Medical Device HACCP - Training Workshop for the Medical Device Industry
April 12, 2000	Duke University Medical Center, Durham NC FDA and Stakeholders Public Meeting - Leveraging
April 11, 2000	North Carolina Regulatory Affairs Forum Special Event, Research Triangle Park NC Dr. Janet Woodcock, CDER Director - Speaker
August 20, 1998	North Carolina Regulatory Affairs Forum, Research Triangle Park NC Mary Lewis, Public Affairs Specialist, FDA, Raleigh NC The Changing Face of the FDA
April 8, 1998	TUV Management Service, Charlotte, NC ISO 9000 Management Seminar
December 11, 1996	FDA, Charlotte NC Atlanta District Grassroots Meeting
December 4, 1996	North Carolina Regulatory Affairs Forum, Research Triangle Park NC FDLI video conference, "Quality System Regulation"
January 20, 1996	ASQC Food, Drug, and Cosmetic Division and FDA, Atlanta District, Research Triangle Park, NC Managing Quality in a Regulated Industry
February 9, 1995 - June 1, 1995 (42 contact hours)	ASQC Section 1109, Greensboro NC Certified Quality Engineer Training Class
January 4 - 5, 1995	Bruce F. Mackler, Ph.D., J.D. and John Messina, J.D., Burlington NC Good Clinical Practice Regulations Workshop
October 11, 1994	North Carolina Regulatory Affairs Forum/North Carolina Pharmaceutical Discussion Group, Research Triangle Park NC The Effect of the Barr Decision on Local Enforcement
June 13 - 15, 1994	ASQC, Denver COGMP Workshop
January 24 - 25, 1994	ASQC, Greensboro NC ISO Internal Auditing
June 28 - 29, 1993	FDLI, Washington DC Medical Device Update 1993
May 6 - 7, 1993	RAPS, Reston VA Regulatory Compliance and Enforcement of Devices
May 3 - 5, 1993	RAPS, Reston VA Medical Device Approvals
April 7 - 8, 1993	RAPS, Atlanta GA Conducting FDA Inspections
February 11 - 12, 1993	FDLI, Washington DC Introduction to Biologics Law
February 24, 1992	IBM, Raleigh NC ISO 9000 Awareness and Familiarization

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