Lillie C. Thomas
Education
B.S. Economics, 1977 Virginia Polytechnic Institute and State University
B.S. Statistics, 1977 Virginia Polytechnic Institute and State University
Academic Diploma, 1974 Maury High School
Professional Affiliations
American Society of Quality 1998 through present
American Materials Society 1996 through present
American Chemical Society, 1997 through present
ACS, Rubber Group, 1997 through present
U.S. Delegation to ISO for Mechanical Contraceptive Devices, 1997 through present
Secretary WG17 on Synthetic Condoms
American Society of Testing Materials, 1996 through present; Member Consumer Products D-11
Task Group Chair: Latex Sensitivities, 1999 through 2006
Task Group Chair: Food Service Gloves 2000 through 2006
American Organization of Analytical Chemists 1990 through present
Statistical Referee: Term December, 1998 through present current terms ends December, 2007
National Association of Professional Accident Reconstruction Specialists 1997 through 2005
Virginia Polytechnic Institute Alumni Association 1977 through present
Work Experience:
3/6/06 through present Interplex Industries Inc. (2006- present)
Positions: Quality Compliance Manager (NAS); Regulatory Manager (PMP) Director Quality and Regulatory (IPX Medical)
Current responsibilities include start up and implementation of medical device contract manufacturing,
quality system development, procedure development and validation of diabetic drug delivery device and hearing aid batteries assemblies in a Class 7 clean environment. Also manage portable Class 7 and Class 5 environments for production of medical molded and stamped components. As part of corporate duties, I coordinated medical device assembly quality systems and risk analysis for 6 sites, three international,
all using the same ISO 13485/FDA compliant quality system. As a clean environment expert, started four separate cleanroom production areas. Quality systems have be updated and harmonized with existing ISO 9001 and ISO/TS 16949 systems. Developed and certified ISO 14001 quality system. Developed and harmonized with existing system an AS9100C quality system. Activities as the result of quality operations resulted in an $8 million automotive award for a new generation of products and Class II diabetic medical device assembly program worth $4 million Quality systems have been audited and approved for
manufacture by Johnson and Johnson Inc. and other tier one medical device designers and developers. Recently completed 1 year overseas assignment to improve EU regulatory skills, and get facility started in Class II medical device manufacturing including a new program complete line of trocars and a female tubal ligation device. (Contracts worth $3 million euros.)
11/30/95 through 12/30/05 Custom Services International Inc.
Position: Management Representative/Vice President of Quality Assurance and Regulatory Compliance
Originally retained as an independent consultant to prepare the required FDA regulatory applications, I agreed to join the Company as Vice President of Quality Assurance and Regulatory Compliance to provide full time GMP and Quality Assurance support in Sept., 1996. After reorganization in December, 2004, my title changed to Management Representative as it reflected the central regulatory and quality role I had in the new organization. I was responsible for certification of the manufacturing facilities in China and India used for medical device manufacturing. As a manufacturer of medical devices, C.S.I. has planned a broad spectrum of products, and I am responsible for all R & D and product development, as well as all internal and external quality assurance. I prepared and implemented the required GMPs, resulting in both the Company and its foreign manufacturing facility passing an initial full FDA inspection with no deficiencies, and subsequent routine inspections. The Company has also implemented its GMP’s and received the necessary regulatory approvals to sell its products. Currently the Company has received fourteen 510(k) releases, 17 amendment approvals. I have developed and conducted risk analysis information for the products manufactured, and prepare, maintain and administer the FDA regulatory system.
9/7/00 through 11/27/05 LMR International Inc.
Position: Plant Director
When LMR’s parent (CSI above) acquired its manufacturing facility in Eufaula, AL on September 7, 2000, I was appointed Plant Director. I was responsible for all facets of facility manufacturing and quality operation and management. I have profit and loss responsibility for the plant operations generating over $10 million in annual sales, operating profitability (subsidiary level) with overall quality level greater than 98.2% and more than 150 employees. Since I assumed responsibility for the facility, the factory has achieved ISO 9001:2000 certification, ISO 13485:2003 certification, and has been inspected three times by the FDA. All regulatory and procedure development occurs under my direction.
9/1/95 through 2006 Research It! Inc..
Position: President, Lead Consultant
I established this company for the purpose of providing consultation in the devising, developing, and implementing regulatory compliance programs for medical products, drug, cosmetic and food manufacturers as well as targeted research projects for determining the safety and effectiveness of medical devices through statistical protocols and validated methods, formulation validation, and formulation development. Clients have included medical device, OTC drugs, cosmetics, and pet foods. The firm develops processes and analyzes physical systems to improve manufacturing and structural conditions to promote good manufacture of medical devices, foods and cosmetics. The firm prepares and develops compliance programs, SOPs, GMPs, and regulatory applications for compliance with applicable FDA, FTC, OSHA, and SEC regulations. The firm also consults on ISO 9000 adaptation of FDA cGMP requirements, and is currently assisting a medical device company in completing ISO 9001 requirements. The firm also provides total quality management training and builds and validates statistical models for TQM. As the primary consultant for the firm, I have been qualified and testified as an expert witness in Nevada and California for FDA and SEC compliance issues. I have also been qualified and testified as an expert in accident reconstruction in both California Superior Court and Nevada District Court. The firm has validated formulas for a cosmetic firm and a pet food company. The firm has also developed and established a complete statistical quality management system for two foreign manufacturers, a medical device manufacturer in China and a cosmetic manufacturer in Brazil. In addition, the firm has developed and established a complete quality system for six domestic manufacturers, four medical device companies, one cosmetic company and one cosmetic/drug company, and developed a quality
system for a pet food company. This Company is currently dormant.
3/1/98 through 7/5/01 PAI Medical Device Services
Position: Regulatory Affairs Associate
I was retained to provide consulting services to medical device manufacturers though the auspices of PAI for the purpose of assisting manufacturers to prepare regulatory submissions to the FDA and develop the necessary management and procedural systems to comply with the QSR I also assisted manufacturers in the design, administration and analysis of clinical research studies, pre-audit inspections of medical manufacturers, preparation of SOPs and required GMP, and Y2K compliance and reporting. For compliance, I have developed a “template set” of SOPs which are compliant with both the FDA QSR and ISO 9001. The “template set” has been audited by the FDA and found to be compliant in several applications and is in use by various manufacturers. I have also been retained to perform “substantial equivalence” analyses regarding medical devices, one of which was used in the preparation of SEC documentation and an IPO.
I served as the Company’s regulatory consultant until it ceased operations in this area in 2001.
4/1/84 through 8/15/96 Crown Laboratories, Inc.,
Position: Vice President of Technical Services
A start up company in April, 1984, I was hired as the primary field representative to interface with long term care and acute care facilities for the sale of the Company=s nutritional dry mix products. After promotion to National Accounts Manager, I was responsible for all sales activities of the Company, reporting directly to the Chief Executive Officer. After an additional promotion to Vice President, I continued to have marketing responsibility and had the primary responsibility for the technical development, explanation, and application of the Company=s nutritional products. This responsibility included, product/production design, nutritional profiles, literature development, marketing approach, product image, literature descriptions, regulatory filings and compliance (SEC, OSHA, FDA). The FDA regulatory compliance included process development and filing, 510(k) applications, label preparation, and documentation of content. Based on the formulations and processes I developed, the Company raised over $12 million to introduce the products to the market. To validate the designs, I conceived, designed, developed and conducted 13 clinical studies (including statistical modeling and analysis) that included over 2,500 patients in long term and acute care settings. Two studies were conducted internationally. These studies were prepared for the purpose of nutritional assessment and decision making by the participating institution. The study conducted in Russia was published in a domestic medical journal by the government of Russia.
2/1/83 through 4/1/84 ARA Living Centers, Inc.
Position: Purchasing Manager, Central Division
I was responsible for all contracting and purchasing for a division of 180 long term care institutions in Texas and Oklahoma. I interfaced directly with the marketing directors of the institutions to promote patient services and census. During my tenure, I negotiated and implemented procurement programs which saved the Company over $750,000 per year. I was responsible to facility management for regulatory compliance with all applicable state and federal long term care requirements and worked directly with the state and federal inspectors to assure full compliance with the applicable regulations and was responsible to assure that all regulatory quality requirements were met by the facilities in terms of goods and services available. (HICFA, OSHA, Medicare, and Medicaid).
4/19/80 through 1/31/83 Gould Inc. Medical Device Division
Position: Purchasing Manager
I was responsible for all contracting and purchasing requirements for the manufacture of pulmonary testing equipment. My responsibilities included the preparation of sections of the 510(k) applications which related to the products incorporated into the Company’s medical devices. During my tenure, a new pulmonary device called a “body box” was developed. The quotation specification and procedures developed by my department are still in use. The specification developed saved the Company $500,000 in design costs, and 15% per unit in production costs.