Leadership
Chief Executive Officer (CEO)
DAVID W. VINCENT is the cofounder, Chief Executive Officer (CEO) and Chief Operating Officer (COO) of Validation Technologies, Inc. He has over 25 years of experience in the Healthcare industry with 20 years in field of validation. With a BS degree in Industrial Microbiology and Mechanical Engineering Technology, Mr. Vincent has expertise in many areas of Quality Assurance, Regulatory Affairs and Validation, including BLA submission preparation, facility and equipment design review, process development and validation, project management, utility and process equipment qualification. He is an experienced conference speaker, training seminar presenter, and has authored many articles on various topics of validation. Currently, Mr. Vincent teaches the "Validation Program for Pharmaceutical, Biotechnology and Medical Device Industries" course (RA776) at San Diego State University (SDSU) for their Regulatory Affairs Master Degree program.
President
HERB MATHESON is the cofounder and President of Validation Technologies, Inc. He has over 25 years of experience in the pharmaceutical, biotechnology, and medical device industries. Validation has been a key responsibility in all positions held by Mr. Matheson, including those of Microbiologist, Process Engineering, Systems Analyst, and Quality Engineer. In addition to extensive experience in the development and validation of computerized data acquisition and control systems, he has a broad background in the validation of process utility systems, process equipment, controlled environments, and sterilization systems. He also has experience in facility and equipment design review, Validation Master Plan preparation, validation project management, qualification protocol preparation, execution and Final Report writing, and SOP preparation.
Vice President - Business Development
GEORGE SHEAFFER is the Vice President of Validation Technologies, Inc, responsible for Business Development and Marketing activities. He has over 30 years of Healthcare experience, including senior management positions, in the following areas: pharmaceutical and biological manufacturing, technology and process development, process validation, technical services, quality assurance, project and environmental engineering, project management, facility planning, maintenance, metrology and safety functions. Experienced with parenteral emulsions, suspensions, aqueous and non-aqueous products, lyophilization and terminal sterilization. Mr. Sheaffer has been responsible for pharmaceutical sterile facility projects from conceptual design through start-up, commissioning and operation.
Regional Director
ED WINNETT has over 20 years of experience in the biotechnology industry. He has developed, executed, and directed the validation of sterilization and depyrogenation processes for manufacturing equipment, including small and large scale bioreactors (20,000L), vessels, transfer piping, autoclaves, filtration trains and ovens to meet FDA, cGMP and MCA requirements. His expertise includes the development of Validation Master Plans for equipment, utilities, manufacturing processes, computer systems and QC laboratories, validation management, project management, with specialized expertise in sterilization and cleaning validation.
Regional Director
ALEX MENDOZA has over 20 years of experience in cGMP compliant pharmaceutical and biotechnology manufacturing environments. He has held positions in validation, project management, automated systems and engineering. Project experience includes new facility construction, commissioning and validation, new equipment validation and quality compliance auditing. His regulatory, quality assurance and quality compliance expertise includes developing quality programs, change control programs, cGMP training modules, gap analysis, QA policies and procedures, and representing validation in regulatory inspections by both FDA and European regulatory agencies.