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
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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 |
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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:
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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