Summary of Qualifications

Senior Consultant and Certified ScrumMaster specializing in 21 CFR Part 11 training, assessment, remediation, validation and project management to provide sustainable compliance in the regulated pharmaceutical environment. He has provided Subject Matter Expert guidance and training for gap analysis and remediation of computer systems validation for major pharmaceutical companies under FDA Consent Decrees. He has performed validation engineering for remote data entry systems for use in clinical trials and the Prescription Drug Marketing Act.
He has managed and conducted numerous training programs for end-user training in basic computer operation and use, network environments, custom Lotus Notes applications and other specialized programs. He has prepared course material and provided training for ACPE accredited conferences on Planning and Remediation of Systems for Part 11 Compliance and Planning and Checking, and Part 11 Assessment and Remediation of Systems for Part 11 Compliance. He also has created custom classroom training.
Synopsis of Experience

Senior Consultant 07/08 04/09 Confidential

• Validation Engineer to Wyeth, Collegeville, PA providing validation services for a Clinical Trial system.
• Data analysis and construction of system data for conversion to Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (STDM).
• Cost and project timeline estimation for PQ Team for clinical trial software/system segments including enhancing an existing estimating tool

Senior Consultant 8/2007 10/2007 Confidential

• Validation Engineer and Project Manager for Wyeth, Collegeville, PA providing validation services for Documentum and for a Computer Based Training system for Documentum.

Quality Assurance Coach 6/2007 Confidential

• Quality Assurance Coach to GE Healthcare, Wauwatosa, WI providing validation guidance for MyLearning, a customized, web based learning management system produced by Plateau Systems, Ltd. for training and assessment.

Senior Consultant 11/2005 11/2006 Confidential

• Validation Engineer and Project Manager for Wyeth, Collegeville, PA providing validation services for Pedagogue Solutions, Inc. Pedagogue Assessment Management System.
• Data analysis and solution design in support of data migration.
• Documentation suite for Pedagogue Assessment Management System.

Senior Consultant 3/2005 4/2005 Confidential

• Validation Engineer and Project Manager for Wyeth, Collegeville, PA providing validation services for Documentum site qualification.

Senior Consultant 12/2004 2/2005 Confidential

• Validation Engineer and Project Manager for GlaxoSmithKline, Upper Merion & Upper Providence, PA providing validation services for DataStream 7i Computer Maintenance and Management System.

Quality Assurance Manager 10/2004 Confidential

• Interim Quality Assurance Manager for Prime Technologies, Inc., West Chester, PA. Hosted and conducted a vendor audit by a major pharmaceutical company.

Senior Consultant 3/2003 4/2004 Confidential

• Validation Engineer and Project Manager for Schering-Plough Corporation, Kenilworth, NJ under an FDA Consent Decree. Validation and validation gap analysis of computer systems used by the IT Infrastructure group in accordance with Full System Development Life Cycle Methodology, Current Good Manufacturing Practices, PDMA and 21 CFR Part 11. Project Lead for a Documentum document management system to incorporate all Computer Information Technology SOPs under a single control group. Subject Matter Expert on the validation requirements for various applications and systems. Infrastructure validation. Compliance support for sales and marketing unit in accordance with the Prescription Drug Marketing Act.

Senior Consultant 2/2002 5/2002 Confidential

• Validation Engineer and Project Manager for Memory Pharmaceuticals Corp., Montvale, NJ providing validation services for a High Throughput Liquid Chromatography Mass Spectrometer computerized system along with IT infrastructure analysis and planning including compliance with 21 CFR Part 11, Electronic Records; Electronic Signatures and 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies.

Senior Consultant 6/2001 5/2002 Confidential

• Subject Matter Expert consultant for The Quantic Group, Inc. for Wyeth-Ayerst, Pearl River, NY under an FDA Consent Decree. Validation and validation gap analysis of computer systems used by the pharmaceutical and vaccine divisions in accordance with Full System Development Life Cycle Methodology, Current Good Manufacturing Practices and 21 CFR Part 11. Writing of SOPs and validation documents. Advisor to various departments on the validation requirements for various applications and systems.

Senior Project Manager 4/2000 8/2000 GMAC Confidential

• Senior Project Manager for GMAC Commercial Mortgage, Horsham, PA. Requirements collection, analysis and development of configuration specifications based on workflow diagrams for the implementation of Hyland’s OnBase integrated document management system for 1500 employees in 225 cost centers worldwide.

Validation Engineer 12/1998 12/1999 Confidential

• Validation Engineer and Project Manager for SmithKline Beecham Research and Development, Upper Merion, PA. Software validation, following Current Good Clinical Practices, of a Remote Data Management system for Clinical Trials that uses an MS Access front end and a replicable Sybase relational database back end and MS Exchange as its replication vehicle for integration into an Oracle database. Using Full System Development Life Cycle Methodology in accordance with 21 CFR Part 11 requirements, created the Functional Requirements and Detail Design Requirements specifications from User Requirements Specifications along with system and protocol level test plan writing and execution.

Supervisor / Project Manager Computer Facilities 10/1997 1/1998Confidential

• Supervisor, Computer Facilities for Wyeth-Ayerst Research, Radnor, PA, a pharmaceutical subsidiary of American Home Products. As Project Manager, prepared budget analyses, contract and lease analyses and schedules for the roll out of a $ 4 million hardware upgrade worldwide and coordinated the roll out of the project. Performed problem resolution for various internal departments with outside vendors. Created the procurement documentation for the System Development Methodology manual for Computer Services in support of the Life Cycle Management program.

Systems Consultant 11/1996 9/1997 Confidential.

• Systems Consultant to Workflow, Inc., Chadds Ford, PA, a Lotus Notes Premium Business Partner. Applications development in Lotus Notes and software validation of a proprietary remote data entry system for use in clinical trials, following Current Good Clinical Practices, for SmithKline Beecham including extensive Documentation, Test Plans, User Guides and Standard Operating Procedures. Installed MS Windows NT Workstations on which were installed a Lotus Notes Server and a Lotus Domino Server. Network redesign and installation.

Associate Director Administrative Services 1992 1996 Confidential

• Developed, installed, documented and maintained LAN-WAN, Novell Networks, Lotus Notes, and SalesForce automation
• Created Lotus Notes workflow and non-workflow type databases
• Selected and implemented MFG/PRO software for accounting, purchasing, and manufacturing at West Chester, PA and Beltsville, MD locations
• Selected and implemented a networked computer based video conferencing system used to collaborate with partners, reducing travel and man-hour costs by $ 1 million annually
• Project management of a $ 6 MM construction project expanding laboratory and office facilities

Education/Certifications

Certified ScrumMaster Agile Project Management with Scrum
Electrical Engineering, Computer Science, Lotus Notes Application Development, Project Management and Business Administration
Drexel and Villanova University - coursework in Electrical Engineering
ICS, Scranton, PA - Electronic Service Technician
IBM Information Systems Group - IBM Cabling System Layout & Physical Installation
Actium, Conshohocken, PA - Lotus Notes R4 Application Development I & II
Rocky & Associates - Introduction to LotusScript in Notes
SmithKline Beecham - FDA Electronic Records and Electronic Signatures Rule (21 CFR Part 11)
Premier UCA - ACPE (American Council on Pharmaceutical Education) accredited conference on Effective Strategies for complying with 21 CFR Part 11 and Related Guidance Documents (Instructor)
Prime Technologies, Inc. - ProCal

Lectures 

• 21 CFR Part 11 The Final Rule - Overview Highlights and Interpretations
• Planning and Remediation of Systems for Part 11 Compliance
• Planning and Checking, Part 11 Assessment and Remediation
• Validation of Computerized Systems
• Planning and Conducting Part 11 Assessments
• Electronic Records Management- Regulatory Requirements-Best Practice - Audit Trails
• Regulatory Requirements, Policies, Guidelines, Procedures
• GLP Attachment A
• FDA & Warning Letters
• Reported Warning Letters
• Effective Strategies for Complying with 21 CFR Part 11 and Related Guidance Documents
• Roles and Responsibilities
• Validation Plan & Design Qualification
• Qualification - IQ OQ PQ Tools
• CSV SOPs & Vendor Audit
• Workshop - 21 CFR Part 11 Assessment
• Workshop - IQ Planning, Conducting & Reporting
• Workshop - OQ Planning, Conducting & Reporting
• Workshop - Risk Assessment
• Workshop - Planning and Checking, Part 11 Assessment and Remediation of Systems for Part 11 Compliance