The FDA is changing the
way it oversees drug quality.
FDA commissioner Lester
Crawford states "We expect
to achieve greater research
efficiencies, easier data
management and lower costs".
See article in Next Generation
Pharmaceutical, p.135.
About Us
Background and expertise of RPCI Principals;
Kim Sesia-Lamers is the founder and president Ridge Pointe
Consulting, Inc. (RPCI), a small business, woman owned company. She is a
senior level consultant for computer systems validation and compliance to
FDA requirements, with 14 years of experience in FDA regulated industries.
She is considered to be an expert on 21 CFR Part 11 compliance (since
1997). She has given presentations at ISPE and PDA conferences, as well as
presentations for leading pharmaceutical companies. Ms. Sesia-Lamers is
experienced in the validation of SFA/CRM systems (since 1996) and has in
depth knowledge of the Prescription Drug Marketing Act (PDMA) regulations,
and information systems that fall under GCP/GLP/GMP regulations. Ms. Sesia-Lamers
is a member of ISPE and currently sits on the Steering Committee for a
large, international pharmaceutical company as an advisor to senior
management regarding validation of a multi-site, international LIMS
implementation. Ms. Sesia-Lamers is involved in all aspects of the
validation project process, including client customer service, project
management (including schedules, budgets, and hiring resources both
internal and contract), SDLC involvement, validation during software
development, validation plans, IQ/OQ/PQ development and execution, and
report writing.
Dan Semeniuk is the co-founder and Principal of Ridge Pointe
Consulting, Inc. (RPCI). He is a senior level consultant for computer
systems validation and compliance to FDA requirements. Dr. Semeniuk has 14
years of pharmaceutical experience in FDA Regulations (GLP/cGMP, 21CFR
Part 11, PDMA, and Medical Devices), 14 years of Project Management
experience and is a current Project Management Institute Member (Tampa Bay
Chapter). He has participated in numerous validation projects involving
computerized systems (including laboratory, clinical, pharmacovigilance,
automated systems, sales, marketing and sample accountability systems,
enterprise resource systems), medical devices, utilities and facilities
and equipment. His major accomplishments specific to this project include
completing the implementation and validation of a multi-million dollar
Siebel system within 5 months, responsible for repeat business, trained
new employees in computerized system validations, cGMPs and sGDPs, and
spoke at conferences on the topics of CRM validation, 21 CFR Part 11
compliance and PDMA regulations. Dan has excellent writing and
communication skills, training and management skills, and is bilingual in
English and French. Dr. Semeniuk has a Ph.D. in Molecular Immunology from
McGill University in Montreal, Quebec, Canada and has had issued several
patents.
• risk-based approach
• streamlining without compromise
• computer system validation
• 21 CFR Part 11
• full system development
life cycle documentation
• regulatory compliance consulting
• compliance audits
• strong project management
• extensive industry experience with major
players
• compliance training
> What's New?
Learn more about FDA's
5 major initiatives, including
Efficient Risk Management.
Also get more information
on FDA's Vision 2006.
Kim Sesia-Lamers is the founder and president Ridge Pointe
Consulting, Inc. (RPCI), a small business, woman owned company. She is a
senior level consultant for computer systems validation and compliance to
FDA requirements, with 14 years of experience in FDA regulated industries.
She is considered to be an expert on 21 CFR Part 11 compliance (since
1997). She has given presentations at ISPE and PDA conferences, as well as
presentations for leading pharmaceutical companies. Ms. Sesia-Lamers is
experienced in the validation of SFA/CRM systems (since 1996) and has in
depth knowledge of the Prescription Drug Marketing Act (PDMA) regulations,
and information systems that fall under GCP/GLP/GMP regulations. Ms. Sesia-Lamers
is a member of ISPE and currently sits on the Steering Committee for a
large, international pharmaceutical company as an advisor to senior
management regarding validation of a multi-site, international LIMS
implementation. Ms. Sesia-Lamers is involved in all aspects of the
validation project process, including client customer service, project
management (including schedules, budgets, and hiring resources both
internal and contract), SDLC involvement, validation during software
development, validation plans, IQ/OQ/PQ development and execution, and
report writing. 
Dan Semeniuk is the co-founder and Principal of Ridge Pointe
Consulting, Inc. (RPCI). He is a senior level consultant for computer
systems validation and compliance to FDA requirements. Dr. Semeniuk has 14
years of pharmaceutical experience in FDA Regulations (GLP/cGMP, 21CFR
Part 11, PDMA, and Medical Devices), 14 years of Project Management
experience and is a current Project Management Institute Member (Tampa Bay
Chapter). He has participated in numerous validation projects involving
computerized systems (including laboratory, clinical, pharmacovigilance,
automated systems, sales, marketing and sample accountability systems,
enterprise resource systems), medical devices, utilities and facilities
and equipment. His major accomplishments specific to this project include
completing the implementation and validation of a multi-million dollar
Siebel system within 5 months, responsible for repeat business, trained
new employees in computerized system validations, cGMPs and sGDPs, and
spoke at conferences on the topics of CRM validation, 21 CFR Part 11
compliance and PDMA regulations. Dan has excellent writing and
communication skills, training and management skills, and is bilingual in
English and French. Dr. Semeniuk has a Ph.D. in Molecular Immunology from
McGill University in Montreal, Quebec, Canada and has had issued several
patents.
