DAVID W. VINCENT has over thirty-one (31) years’ experience in the health care industry specializing in the Biotechnology and pharmaceutical industries. He has over (20) twenty years dedicated to the field of commissioning and qualification (CQ). He has degrees both in industry microbiology and mechanical engineering technology. He has hands on experience in many areas of Regulatory Affairs, Quality Assurance and Commission/Qualification, Engineering including; regulatory submission preparation, Design Review, Construction Qualification, Project Management, Utility and Process FAT/SAT Commission Plans, and Equipment Qualification implementation. He is especially strong in the areas of Process Development and Validation as well as developing and implementing Environmental Monitoring Programs.
Mr. Vincent has spent the last twenty-five (25) years providing validation and quality consultant services to various national and international companies. During this time, he has provided both project management and project execution for numerous clients around the globe. He is responsible for managing and supporting many different product launches. He has written many articles and technical guides on various topics such as Risk Management, Cleaning Validation (Technical Guide), Biological Facility Validation (Technical Guide), Utility System Commissioning and Qualification, etc. He teaches at San Diego State University (SDSU) for their Masters of Regulatory Affairs Degree program in the Field of Validation Technology RA-776.
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.
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.
WILLIAM HONECK is the Northern California Regional Director for Validation Technologies, Inc. He has over 25 years of experience in the pharmaceutical, biotechnology, and medical device industries. Mr. Honeck has led numerous validation projects while serving in Analytical Development, Quality Control, IT, and Quality Assurance capacities. His expertise includes validation project management, development of Validation Master Plans, validation SOPs, risk assessments, and qualification protocols for computerized systems, utilities, equipment, and analytical instruments with a focus on data integrity.
Mr. Honeck has a B.S Degree in Biochemistry from University of California, Davis.
LANA HARTSON is the Human Resource Manager for Validation Technologies, Inc.