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Curriculum Vitae

Take me to:

Objective

Background Summary

Areas of Expertise

Management Skills

Professional Accomplishments

Experience

Educational Background

Professional Affiliations

Objective

To use my 30 years of Good Manufacturing Practices and Regulatory Affairs experience supporting startup/small companies by providing practical, effective, and cost-efficient solutions to their compliance needs.

Background Summary

Over 30 years designing, implementing, and managing GMP and Regulatory Affairs systems
Development, clinical trial, and commercial pharmaceuticals, biologicals, medical devices, & in vitro diagnostics
BS Biology-Chemistry & Political Science; 32 credit hours toward an MBA
CQM, CBA, & CQA certification; working on Regulatory Affairs certification
Training in and working knowledge of Good Laboratory Practices (GLP)
Device and pharmaceutical submissions to the FDA
Heavy exposure to and involvement in Clinical Studies

Areas of Expertise

Designing & implementing GMP systems
Quality/GMP improvement & remediation
Supplier & outsourcing qualification
Value-added internal & external auditing
Pre-Approval Inspections (PAI)

GMP Training & Instruction
Corrective and Preventative Action (CAPA) systems
Documentation & Change Management
Regulatory submissions
Reduced testing programs

Management Skills

Managing People/Leading Groups
Changing/Improving Systems & Processes
Diagnosing & Evaluating Situations
Problem Solving

Teaching and Training
Planning
Persuading and Negotiating
Systematizing

Professional Accomplishments

Visualizing, designing, & implementing GMP Quality Systems that resulted in successful product launches

Directed the design, staffing and implementation of a startup combination medical device & pharmaceutical manufacturing and packaging operation
Directed the design, staffing and startup of an active pharmaceutical ingredient and a drug product manufacturing facility
Directed the development & implementation of a GMP system for a virtual biotech company for control of internal QA and all contractor outsourcing

Improving & remediating quality systems to solve problems and/or to improve efficiency, effectiveness, & compliance

Reconstructed the quality system of a medical device contract manufacturing site to meet device quality and regulatory affairs regulations, resulting in customer’s compliance requirements being met
Worked with Senior QA management, the FDA, and consultants to recommend and implement solutions to compliance issues resulting from a consent decree and/or warning letters
Designed & implemented supplier & outsourcing programs, including databases for managing audits, contractor & supplier qualification, follow-up & corrective action, raw material specification controls, and risk-based reduced testing programs
Guided the restructuring of material flow that resulted in reducing scrap 30% and labor 20%, thereby increasing overall productivity by 20%.Resulted in the ability to manufacture a customer’s new product without expanding the facility.
Led efforts to streamline the fabrication, assembly, and packaging of medical devices that reduced labor by 20% and increased output by 15%. Resulted in adding new kit and tray lines without increasing labor count or expanding the facility.
Initiated quality planning system for new product development that tracked design, development, prototype, scale-up and validation. Coordinated quality and regulatory requirements with business plan and customer needs
Led a cross functional team to qualify a monoclonal antibody (MAB) contractor for a life-sustaining biological. Quickly learned the MAB production and purification process and the associated regulations. Directed corrective actions and assisted in the technology transfer. Resulted in project goals being met.
Initiated a corporate-wide statistical process control for an international corporation
Assisted in leading an ad hoc quality group to establish a corporate quality facilities management function

Regulatory Affairs

Successfully submitted pharmaceutical and medical device submissions to FDA & Health Canada
Persuaded FDA to reclassify a product from drug to medical device, then guided efforts to obtain approval via the 510K route (mini-PDA), resulting in speedier approval of the device
Successfully petitioned NRC medical committee to amend regulations adding palladium as a standard radioisotope for medical use. Improved shipping efficiency and delivery time to customer.

Training & Instruction

Directed the training for personnel in a combination medical device and drug facility to include on-the- job and GMP training. Utilized GMP workbooks, seminars, and outside consultants as well as personal direction. Expanded training to include other affected USA & European sites.
Assisted in leading a large pharma’s ad hoc GMP Training Improvement team to improve introductory GMP training. Efforts resulted in improved attendee course tests and evaluations.
Instructed GMP classes for a large pharma company. Received very high class evaluations.
Developed GMP training courses based on CFR Parts 210 & 211 and Part 820
Assisted division of a large pharma manufacturer to establish an effectiveness based training program

Experience

Associate Quality Consultant, Corporate QA Development Staff, Eli Lilly and Company, Indianapolis

Provided compliance and quality consultation to Corporate and Third Party sites. Included sites in the United States, Japan, & Europe.
Led and participated in audits of Corporate, Third Party, and contract sites. Included follow-up to assure corrective and preventive action was complete and effective.
Involved in the ongoing review and approval of Corporate QA/GMP policies
Corporate QA Consultant to Company’s Medical Device Operations

External Audit Group Leader, Aventis-Behring, Chicago area

Implemented a supplier audit and qualification program to meet FDA regulations
Performed and led supplier qualification audits and supplier quality improvement activities
Provided quality and compliance expertise to Computer Validation, Materials Management, and Laboratory Information Management Project

Pharmaceutical Compliance Manager, BOC Gases/Ohmeda Pharmaceutical, Baton Rouge

Managed the QA/GMP function for design, startup, and validation of bulk and finished drug facilities. Assisted in the quality and regulatory management of medical gases.

Manager, Regulatory Compliance, Lemmon Company, Div. of TEVA Pharmaceutical, Philadelphia.

Managed the compliance function for manufacturing solid and liquid dosage forms. Developed and managed internal and external audits. Participated in process validation. Primary contact for FDA inspections.

Director, Medical & Regulatory Affairs, Theragenics Corporation, Atlanta

Manager, Regulatory Affairs & Quality, Avery Medical, Div. of Avery, Cleveland

Director, Quality Assurance, Akron Catheter/Latex Industries, Cleveland

Assistant Dept. Head, Brewing Quality Control, Anheuser-Busch, St. Louis & Cleveland

Educational Background

BS, Biology/Chemistry & Political Science, University of Arkansas, Little Rock, AR
32 credit hours toward an MBA, Lake Erie College, Painesville, OH (GPA=3.6/4.0)

Professional Affiliations

American Society for Quality -CQA & CQM Certification; Biomedical Quality Auditor Certification
Association for the Advancement of Medical Instrumentation (AAMI)
Midwest Society of Quality Assurance (MWSQA); presented at conferences and active in conference planning.
Society of Quality Assurance (SQA)
Parenteral Drug Association (PDA)
Regulatory Affairs Professional Society (RAPS)

Curriculum Vitae

Over 30 years designing, implementing, and managing GMP and Regulatory Affairs systems

Development, clinical trial, and commercial pharmaceuticals, biologicals, medical devices, & in vitro diagnostics

Quality/GMP improvement & remediation

Supplier & outsourcing qualification

Persuading and Negotiating

Corporate QA Consultant to Company’s Medical Device Operations