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SUBJECT MATTER EXPERT

& PROJECT MANAGER

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.

Companies for which I have been employed:

Summit Regulatory Services, Inc. 2007 Current

CimQuest, Inc. 1998 2007

Geneva Pharmaceuticals Inc. 1995 1998

Syntex Agribusiness, Inc. Nutrition & Chemical Division 1981 1995

Consulted with the following companies:

Amgen, Inc.

American Red Cross

Analytical Bio-Chemistry Laboratories, Inc.

Centocor, Inc.

Centre Analytical Labs, Inc.

Dendreon Corporation

Fisher Clinical Services, Inc.

General Electric Company

GlaxoSmithKline Pharmaceutical, Ltd.

Hoffman-La Roche

McKesson Packaging

Merck & Company, Inc.

NanoSystems, Inc.

Nastech Pharmaceuticals, Inc.

Navajo Manufacturing Company

Novartis Business Services U.S.

Novartis Consumer Health, Inc.

Ortho-McNeil

L AR RY F O R T N E Y

PR Pharmaceuticals, Inc

Protein Design Labs, Inc.

Sandoz, Inc.

U.S. Department of Agriculture Food Safety and Inspection Service

Zimmer, Inc.

L AR RY F O R T N E Y

Project & Team Management


o

As a Project or Team Manager, general responsibilities included for applicable projects:

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.

Specific projects include:

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:

Remote vendor/software assessments for compliance to 21 CFR Part 11 and


assisted in the development of validation life cycle document templates.

Participated in the development of a global alignment process for Quality


Laboratories assessment/remediation/validation of laboratory instruments for 21
CFR Part 11.

Project Manager of consultants for validation of 29 laboratory systems at domestic and


international facilities. Responsible for the successful completion of the project, utilizing
client and consulting company resources for computer system validation.

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.

Computer Systems Validation (CSV)


o

Provide development of decommissioning and system retirement deliverables (System


Retirement Plan and Final Report) for manufacturing GxP computerized systems that are
included in the companys Decommissioning Plan and Master Validation Plan.

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.

Provided validation/QA review of executed protocols for an in-house developed system


(Intellivenge) used for scheduling delivery of product, and for a performance enhancement to the
in-house developed ERP system.

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.

CSV developed and implemented for the following systems:

Business Systems

CAPA system (Sparta Systems, Inc. TrackWise 7.0)

Enterprise Clinical Trial Materials Management System (Clinical Distribution


System (CDS), Global Project Management (GPM) and Production Automated
Scanning System (PASS))

Envirotrac Computerized Environmental Monitoring System

Mystic Management Systems Ensur Document Management System

Laboratory systems:

LabWare Laboratory Information Management System (LIMS).

BioRad GS-800 Densitometers

MicroDynamics Plate Reader

Waters Acquity UPLC with LAC/E.

Waters Alliance HPLC systems

Waters 600 series HPLCs with Waters 2487 Dual Wavelength Absorbance
Detectors

Waters 2695 HPLCs with Waters 2487 or 2489 Dual Wavelength Absorbance
Detectors

PE Lambda 45 UV-Vis Spectrometer (UV WinLab v2.85)

Waters Acquity UPLC connected to a Micromass Q-TOF Ultima API TOF Mass
Spectrometer (LC/MS)

Sievers Total Organic Carbon (TOC) system

Waters Empower 2

Beckman Coulter AcT 5diff Cap Piercing Hematology Analyzer

BioMerieux BacT/Alert (and 3D) Microbial Detection Systems

L AR RY F O R T N E Y

BioTek ELx808 Absorbance Microplate Readers with BioTek's KC4 and Lonza's
WinKQCL software.

Applied Biosystems LC/MS (API 150, API 3000)

Perkin-Elmer Diamond DSC

FOSS NIR 5000 system II

Agilent UV-Vis 8453 (2 stand alone and 1 w/Distek online dissolution)

Leak Detectors (1 PTI 325, 1 ATC IGLS model E)

Wyatt Technology DynaPro Plate Reader

MS Excel spreadsheets (pipette calibration, Biacore data computation and


reporting)

VTI Corporation, Inc. Symmetrical Gravimetric Analyzers (SGA-100)

Lighthouse Instruments, Inc. Headspace Gas Analyzers (FMS-1400, FMS-1400H)

Micromass LCT

Thermoquest LCQ

Metrohm Titrator

Differential Scanning Calorimeter

Nikon Microscope

Biacore Plate Readers

Beckman-Coulter Vi-Cell XR Cell Viability Analyzer System (SW vs. 2.03)

Molecular Devices SpectraMax Gemini EM Fluorometer using SoftMax Pro 4.7.1

Chemunex ChemScan RDI (automated bioburden) using ChemScan software


version 3.3.0

BioRad Fluor-S MultiImager, Quantity One 4.4

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

Quality Assurance / Software Quality Assurance (SQA)


o

Provided Quality Management reviews and guidance for GxP and non-GxP systems for the
manufacturing, laboratory, and business areas, including:

ProFicient InfinityQS

Siemens Building Management System

FactoryTalk (Batch, AssetCentre and Transaction Manager)

L AR RY F O R T N E Y

Systech Vision System

Informance

Empower 3

ContainerWise

Systech Vision System

POMS OS2 Labeler System

Liquid Manufacturing Area Clean-in-Place Control System

TEKLYNX Central CFR Printing System

Markem Printing System

Automated Material Handling System

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.

FTTM and SSRS for Roll Compactors in a manufacturing suite.

Measurement Control Corporation (MCC) Advanced Instrument Monitor (AIM) Tablet


Press Monitor Software Upgrade

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 validation deliverables for an in-house


developed MS Access database application used to enter, view, store, maintain and report
information pertaining to specific aspects of the companys business operations (i.e.,
documentation, QC test results, raw materials, manufacturing process, quality records). Provided
documentation review and comments against Current Good Manufacturing Practices, 21 CFR
Part 11 and generally accepted industry practices.

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.

Additional experience and depth of knowledge in:

Computerized life-science development and business processes involving various types of


systems (e.g. LIMS, CDS, CAPA).

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.

Good Automated Manufacturing Practices 5 (GAMP5).

Hands-on evaluation, development, and/or remediation of:

Computer Validation policies and procedures, including training materials and life-cycle
management processes.

Global business systems including laboratory, clinical, CAPA, electronic document


management, and electronic records/signatures.

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.