| |
|
Haleh
Hughes (Director/Consultant)
Mrs. Hughes is the founder of
Total Validation Services, which was incorporated
in 1992. She has over seventeen (17) years of direct
Validation Experience in the Biopharmaceutical and
Medical Device industries. Ms. Hughes' expertise is
in project management, budgeting, planning and scheduling
for large validation projects from conceptual design
through commissioning and start-up, qualification
and process validation. She has been successful in
helping clients attain facility licensure. Ms. Hughes
also has strong technical experience in utility and
process equipment validation, process validation,
and cGMP compliance, auditing and regulatory issues.
Ms. Hughes has worked all over the United States and
throughout Europe, and is familiar with FDA and European
guidelines. Ms. Hughes holds a BS Degree in Biopsychology
from the University of California, Santa Barbara,
and a Masters of Business Administration (EMBA) degree
from Saint Mary's College in Moraga, CA.
Ms. Hughes was the past President for the ISPE San
Francisco Chapter (1999-2000), and served on the task
team that wrote "Streamlining Validation",
published in ISPE's Pharmaceutical Engineering magazine
|
|
| |
|
John Hughes (Director/Operations)
Mr. Hughes is the Director of
Operations for Total Validation Services, responsible
for internal operations, project planning, budgeting,
forecasting, proposals and presentations and client
relations. Mr. Hughes has over fourteen (14) years
of experience in the Biopharmaceutical industry,
working in Engineering design, Startup/Commissioning,
Qualification/Validation and Project Management.
Mr. Hughes has strong technical experience in utility
systems and process/manufacturing equipment design
and qualification. Mr. Hughes has strong managerial
experience in project planning and staffing, managing
a staff of 75 plus commissioning/qualification/validation
staff globally with offices located in California,
Puerto Rico and various project sites throughout
the United States.
Mr. Hughes has worked in United States and Europe,
and is familiar with FDA and European guidelines.
Mr. Hughes holds a BS Degree in Mechanical Engineering
from University of California, Santa Barbara, and
a Masters of Business Administration (MBA) degree
from Pepperdine University in Malibu, CA.
In addition to managing TVS’ operations, Mr.
Hughes is one of two founders of TVS’ sister
company, Global Turn Key Services (GTKS) in Puerto
Rico, and is the West Coast Director of Operations
for GTKS. Also, Mr. Hughes was part of the West
Coast task team who wrote the “Commissioning
Chapter” for the ISPE Commissioning and Qualification
Guide.
|
|
| |
|
Corey Veverka (Manager of Projects)
Mr. Veverka has over eleven
(11) years of experience in Bio-Pharmaceutical facility
validation, engineering, start-up and commissioning.
He has in-depth knowledge of Cell Culture, Purification,
and Fill Finish operations. His validation experience
covers equipment, control systems, facilities and
utilities qualification, for various types of CGMP
facilities. His managerial activities include project
coordination, scheduling, staffing, as well as operational
and business development responsibilities. Mr. Veverka
has served as Validation Manager of West Coast Operations
for a Multinational Engineering Consulting Firm.
His responsibilities included EPCV project integration,
detail design review, QA for engineering procurement,
start-up, commissioning and validation. He has managed
several projects with staff upwards of 30 validation
specialists with new facilities as large as $150m
TIC.
Mr. Veverka has a BS degree in Mechanical Engineering
from Villanova University. Mr. Veverka presented
a validation program at an Interphex conference
and is a board member for the West Coast ISPE chapter
|
|
| |
|
Arnold Asuncion (Process and
Quality Consultant)
Mr. Asuncion has over twelve
(12) years of experience in the biopharmaceutical
industry, including quality assurance, validation,
engineering, start-up, and commissioning experience.
Mr. Asuncion has knowledge of sanitary utilities,
facilities operations, process equipment, biotechnology
manufacturing operations (cell culture, purification,
and fill/finish), laboratory controls systems, and
quality and compliance systems. As Associate Director
of Quality Assurance at BioMarin Pharamceutical,
Inc, Mr. Asuncion played a role in the successful
validation, regulatory approval, and supply of two
biotechnology drug products. Mr. Asuncion developed,
implemented, and refined key Quality system programs:
including Validation, Global Change Control, Document
Control, Multi-Product Manufacturing, and Regulatory
Inspection Management, and played a significant
role in the development and refinement of many other
technical operations programs.
Mr. Asuncion has a BS degree in Mechanical Engineering
from University of California, Berkeley.
|
|
| |
|
Gustavo
Franco
Gustavo has over twenty years
of experience as Project Director/Manager with several
multinational corporations on projects ranging from
pharmaceutical product facilities (solid oral dose,
sterile liquids, lyophilized product, and packaging),
API Plant, Fermentation & Purification, distribution
control system design, installations and plant/laboratory
construction. He has held key roles in capital expansion
projects from the conceptual stage through turnover
and start-up and validation.
|
|
| |
|
Alfred Thompson
Fred has 25 years of experience
in Pharmaceutical design engineering, validation,
manufacturing, packaging, start-up and commissioning,
regulatory compliance and quality assurance. He
has in-depth knowledge of pharmaceutical manufacturing
operations including kilo-lab scale, semi-works,
and bulk pharmaceutical production. His validation
experience covers product transfer, equipment qualification
and utilities and BMS systems, processing and cleaning
validation, master plan preparation and execution
of protocols, batch records, Fred has served as
a director of validation on domestic and international
projects. He has conducted CGMP quality audits for
review of engineering detailed drawings for facility
design. His managerial activities include project
coordination, scheduling and staffing. He serves
as a consultant to clients on process commissioning
and cleaning validation technical issues. Fred was
a senior executive director for Fluor Daniel enterprises.
His responsibilities included EPCV project integration,
detail design review, start-up and commissioning,
including validation. Fred Managed a staff of 150
validation engineers globally with offices located
in Puerto Rico, Ireland, England and the East/West
coast of USA. Revenues in validation exceeded 20
million dollars. He has been Project Director and
Manager for Pharmaceutical Projects with TIC Values,
30 million to 600 million, including Parental, Biotechnology,
Secondary, Bulk Chemical and Medical Device Industries.
|
|
|
|
|
