Leadership
 
CONTACTS :

David W. Vincent - CEO
davidv@validation.org

Herb Matheson - President
hmatheson@validation.org

George Sheaffer - Vice President
West Coast Office

Ed Winnett - Regional Manager
East Coast Office
edw@validation.org

Alex Mendoza - Regional Manager
Los Angeles Office


 
Chief Executive Officer (CEO)
DAVID W. VINCENT is the cofounder and Chief Executive Officer (CEO) and Chief Operating Officer (COO) of Validation Technologies, Inc. He has over 23 years experience in the health care industry with 17 years in field of validation. He has BS degree in Industrial Microbiology and Mechanical Engineering Technology degree; he has consulted for many companies national and international. Mr. Vincent has expertise in many areas of Quality Assurance, Regulatory Affairs and Validation, including BLA submission preparation, facility and equipment design
Chief Executive Officer (CEO)
review, process development and validation, project management, utility and process equipment qualification. He has been involved in the various aspects of bringing many new drug manufacturing facilities on-line, from design concept and engineering, through construction and start-up, to the qualification/validation, and licensing phases. He has presented many training seminars and written many articles regarding validation topics. He teaches "Validation Program for Pharmaceutical, Biotechnology and Medical Device Industries "RA 776" at San Diego State University (SDSU) for their Regulatory Affairs Master Degree program.

President:
Mr. Matheson is the cofounder and President of Validation Technologies, Inc. He has over 23 years 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. Mr. Matheson has extensive experience in the development and validation of computerized data acquisition and control systems as well as 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 - West Coast Office:

Mr. Sheaffer is the Vice President of Validation Technologies, Inc, responsible for business development and marketing activities. He has over 23 years of Healthcare experience including senior management positions in 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. George has been responsible for pharmaceutical sterile facility projects from conceptual design through start-up, commissioning and operation.

Regional Manager - East Coast Office:
Mr. Ed Winnett has 16 solid years in the biotechnology industry. He was employed at Biogen Inc. for 15 years and held the position of Validation Manager, North America. He was most recently with DOW Chemical, Biotechnology Contract Manufacturing Services as Associate Director of Validation prior to joining Validation Technologies Inc. as the Northeast Regional Manager.
Mr. Winnett has acted as project manager for validation activities for small and large capital projects. He has managed diverse teams for successful validation of small scale (100L) and large scale (20,000L) bacterial and mammalian process equipment in addition to aseptic filling, utilities and facilities validation. He also as successfully represented validation in regulatory inspections by the USA, Canadian and European regulatory agencies leading to licensure of two major products.


Regional Manager – Los Angeles Office:
Alex Mr. Alex Mendoza has over 15 years experience in GMP-compliant pharmaceutical and biotechnology manufacturing environments.  He has held positions in Validation, Project Management, Automated Systems and Engineering.  Prior to joining Validation Technologies Inc in April 2000, he held Validation Manager positions at Schein/Watson Pharmaceutical in Phoenix, Arizona and at Gensia-Sicor/TEVA Pharmaceuticals in Irvine, California.  His 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.

 

 

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