Escolar Documentos
Profissional Documentos
Cultura Documentos
LARRY D. FORTNEY
12661 James Circle
Broomfield, Colorado 80020
Phone: (303) 884-3123
Fax: (303) 469-7782
larry.fortney@summitregserv.com
35+ years system regulatory compliance experience within the pharmaceutical, biotech and
medical device industries.
Amgen, Inc.
Centocor, Inc.
Dendreon Corporation
Hoffman-La Roche
McKesson Packaging
NanoSystems, Inc.
Ortho-McNeil
L AR RY F O R T N E Y
PR Pharmaceuticals, Inc
Sandoz, Inc.
Zimmer, Inc.
L AR RY F O R T N E Y
Ensured all services were completed and all supporting documentation generated to
substantiate compliance with client and consulting company policies and regulatory
requirements. Monitored projects and reported to consulting company and client
management in accordance with consulting company project controls.
Provided input to proposals and assisted the VPO in assessing staffing needs for project
support. Responsible for leading project teams and ensuring that projects were completed
within budget, schedule and in conformance within applicable quality, technical and
regulatory requirements.
Developed Quality & Project Plans delineating scope of Systems Regulatory Compliance
Services, applicable quality programs and SOPs, roles, responsibilities and deliverables.
With assistance from the client and consulting company, developed project schedules,
budget and manpower loading including monitoring of progress, conducting periodic
project/client review meetings. Coordinated schedule/priorities and development of
recovery plans as necessary.
Assured all systems regulatory compliance activities were performed in accordance with
client, and as appropriate, consulting company SOPs.
Global management of a 21 CFR Part 11 project, including gap analysis activities and
remediation. Responsible for approximately thirty consultants working either remotely or
at facilities in Puerto Rico, California, Washington, and Colorado. Primary responsibilities
included:
Project Manager hired to direct the prospective computer system validation of all new
computerized laboratory systems for a new manufacturing facility. Team consisted of
seven senior validation consultants working with client team members in production of the
CSV deliverables.
Project Manager responsible for reviewing and approving System Life Cycle
Documentation in support of computer system projects. Assisted in the creation of the
Computer System Validation Program including SOPs and validation templates governing
the creation of validation system life cycle documentation.
L AR RY F O R T N E Y
Brought in to troubleshoot and manage a project because it was behind schedule and the
client was dissatisfied. Successfully regained the clients confidence and completed the
project with a high level of client satisfaction. Project extension was the result of
turnaround in client confidence. Managed a seven-person team, assisted in the
development of the Computer Systems Validation Policy, GAP Analysis form, summary
documents, and exclusion justifications. Responsible for project scheduling, manpower
loading, and cost estimates for filling in the gaps found in the GAP analysis.
Managed a team of four consultants for the verification of laboratory spreadsheets and
databases.
Provided project guidance and technical direction to client personnel and consultants, and
was responsible for the development of cost estimates, Y2K test plans, project schedules,
software assessment, testing, and assisting in the remediation of all laboratory systems
for Year 2000 compliance.
Worked as an Information Governance and Management (IGM) Manager to consult on nonGxP and GxP projects by guiding, reviewing and approving SDLC validation documentation for
computer-related systems based on internal local and global procedures, as well as ensuring
compliance with FDA regulations, including 21 CFR Part 11.
Worked as a Project Quality Manager (PQM) for the Global Information Services (GIS)
department to author and/or review and approve SDLC documentation for GxP computer-related
systems based on internal local and global procedures. Deeply involved with project teams for
guidance of projects for compliance with FDA regulations regarding computer system validation,
21 CFR Part 11, and internal quality standards.
Also worked with the Global QA & Compliance department as a QA/e-Compliance consultant
to review and approve validation life cycle documentation as needed.
Provide consultation regarding the development of the companys validation deliverables for a
Stability LIMS implementation/validation project. Provide documentation review and comments
against Current Good Manufacturing Practices, 21 CFR Part 11 and generally accepted industry
practices.
L AR RY F O R T N E Y
Inspect current validation documentation for a LabWare LIMS and implement changes: 1)
streamline the management of the validation documentation, 2) perform a gap assessment of the
documentation for compliance to validation plan and requirements, 3) ensure conformance to
ISO17025 and 21 CFR Part 11 Electronic Records and Electronic Signatures in order to meet ISO
accreditation, and 4) revalidate the system covering any compliance gaps, existing functionality
not originally tested and/or documented.
CSV validation project documentation deliverables included: High Level Risk Assessments,
Electronic Records/Electronic Signatures Assessment, Validation Plans, User Requirements
Specification, Functional Requirements Specifications, Functional Risk Assessments,
Configuration Specifications, Data Migration Plans, Test Plans, Installation Qualifications,
Operational Qualifications, Performance Qualifications, Requirements Traceability Matrix, Test
Plans, Validation Summary Reports, Retirement/Decommissioning Plans & Reports, and Periodic
Review Reports, or equivalents and as specified by each client.
Business Systems
Laboratory systems:
Waters 600 series HPLCs with Waters 2487 Dual Wavelength Absorbance
Detectors
Waters 2695 HPLCs with Waters 2487 or 2489 Dual Wavelength Absorbance
Detectors
Waters Acquity UPLC connected to a Micromass Q-TOF Ultima API TOF Mass
Spectrometer (LC/MS)
Waters Empower 2
L AR RY F O R T N E Y
BioTek ELx808 Absorbance Microplate Readers with BioTek's KC4 and Lonza's
WinKQCL software.
Micromass LCT
Thermoquest LCQ
Metrohm Titrator
Nikon Microscope
MIDI, Inc. Microbial Identification System using Agilent GC, Sherlock 4.0
Bayer Rapidlab 860 Blood Gas Analyzer and Rapidlink Data Management
Software (included validation of a dedicated IS server)
Thermo Scientific iCE 3000 Series Atomic Absorption Spectrometer with SOLAAR
and SOLAARsecurity software
Provided Quality Management reviews and guidance for GxP and non-GxP systems for the
manufacturing, laboratory, and business areas, including:
ProFicient InfinityQS
L AR RY F O R T N E Y
Informance
Empower 3
ContainerWise
QA support and oversight of interface, Validation & Verification, configuration verification, and
data migration testing activities, including QA reviews of project deliverables and providing QA
guidance. Performed reviews of executed test scripts and observations within Hewlett-Packard
(HP) Quality Center. All QA tasks were in support of the implementation of a MAK-System
ePROGESA software system.
Hired to perform Quality Management reviews, which included:
FactoryTalk Transaction Manager (FTTM) and SQL Server Reporting Services (SSRS) for
a Compressed Air Flow Control System for a manufacturing line.
Vendor on-site executed qualification deliverables from Leap Technologies, Inc. for the
OPT-DISS and OD Lite UV Fiber-Optic Spectrometer systems against 21 CFR Part 11
requirements.
Assisted in the performance of a quality audit of a new 118K square-foot warehouse facility
which will handle returns and distribution, and documented the findings in an audit report to
internal Quality Assurance.
Provided consultation regarding the development of the companys validation deliverables for
a Stability LIMS implementation/validation project.
Provided documentation review and
comments against Current Good Manufacturing Practices, 21 CFR Part 11 and generally
accepted industry practices.
Performed periodic reviews to determine validated status for computerized laboratory and
manufacturing systems. Submitted the reviews to the client for remediation planning.
L AR RY F O R T N E Y
Responsible for reviewing and approving System Life Cycle Documentation in support of
computer system projects. Assisted in the creation of the Computer System Validation Program
including SOPs and validation templates governing the creation of validation system life cycle
documentation.
Provided Quality Assurance expertise in the development of a systems life cycle methodology
for validation documentation for laboratory, clinical and business systems, development of SDLC
templates, and provided guidance to client personnel and consultants in the development of
validation documentation.
Assisted in the QA review and approval of Enterprise Resource Planning (ERP) system, which
was SAP, generated validation documents.
Federal regulations, including 21 CFR Part 11 (Electronic Records and Electronic Signatures)
remediation planning and implementation across all aspects of the business operations.
cGxPs for Pharmaceutical, Biologics, Medical Device, and Quality Systems: 21 CFR Parts
210, 211, & 820.
Computer Validation policies and procedures, including training materials and life-cycle
management processes.
Vendor and internal compliance audits, GAP analysis, and evaluations for regulatory
inspection preparedness.
Granted Level 1 security access after a National Agency Check with Inquiries (NACI) in 2008.