Thomas Lauria

EXPERIENCE DEPTH

• Computer System Validation expert with 30+ years’ experience in FDA regulated environment

• Project management skills demonstrated in multiple project environments, fast track/Legacy/Greenfield projects. Managing small (2-4) groups to large (15 or more) groups of diverse skill sets to focus efforts to meet aggressive timelines in validation remediation activities in the pharmaceutical, biotech and medical device area

• Qualified for both procedural and technical remediation for 21 CFR Part 11

• Full Validation Life Cycle experience including developing and maintaining Computer System VMPs, Validation Plans, Validation Scripts, and preparing Validation Reports

• Experience in conducting compliance audits including vendor audits, process mapping and gap analysis

• Demonstrated success in interviewing user organizing to gather understanding of needs and requirements

• Track record for providing definitive compliance technical expertise for Manufacturing and Quality software, hardware and instrument related projects including acting as Subject Matter Expert on 21CFR Part 11

• Insight into the inner workings of pharma/biotech/med devices manufacturing applications supported by background and training.

• Aseptic

TECHNICAL SKILLS

Environments: PLCs (Allen Bradley, Modicon, etc.), Client-Server, PC (NT, 2000), Distributive Control Systems

Life Sciences: FDA Quality System Regulation, IQ/OQ/PQ, FDA Compliance, cGMPs Audits, 21 CFR Part 11, Complaint Reporting Systems, Bar-Code Systems, Vision Systems, PLCs, SOPs, SCADA systems and server based systems

Software: PI Data Acquisition (OSISoft), ABI LIMS System, EZSubs®, TrackWise®, MAXIMO® MICROSOFT WORD, EXCEL, MICROSOFT PROJECT, MICROSOFT POWERPOINT, etc. Data transfer from production equipment to higher level supervisory systems (SCADA), vision systems, etc.

Project Management : Ford, Glaxo; Keebler; PPE; Phillips; St, Jude;

EDUCATION

Bachelor of Science Electrical Engineering Technology

Old Dominion University, Norfolk, Virginia

Associate of Applied Science

GSAF-Ground RaDIOEQUIPMENT REPAIRMAN 30454-6R FLR-91966-1967

METAL FABRICATION-STUCTURAL STEEL LAYOUT,MECHANICAL ASSEMBLY,WELDING,BLUEPRINT TAKEOFFS,1962-1966.

PROFESSIONAL HISTORY

Keebler

Raleigh N.C., Snack food Plant

Plant Engineer

Responsible for process an manufacturing equipment and all sitef, sanitation facilities and utilities.

Maintain corn cooking and frying activities with high speed packaging to meet production and sales projections for new product.Automated cooking and corn grinding operation,cooking,frying,packaging,

Independent Consultant- Youngsville, NC 5/2018 – Present

Senior Consultant (Confidential Clients)

• Provide Quality Compliance oversight for GxP activities, review CQ&V documentation, analyze plans, make recommendations, review and disposition of related deviations/CAPAs.

USAF technician Ground radio maintenance-speial training in passive electronic countermeasures ECM weapons system,radio direction finding and associated equipment. 4/1966to 4/1969

Chesapeake and Potomac-No. 5 crossbar switchman- maintain telephone equipment in district (CDO’s) offices.

Germanna Community College earned

Associates degree in Science in Electrical Engineering 9/1966/1972 (AAS)

Old Dominion University,BS electrical Engineer 8/1972 to1977

Ford Motor Company,Canton Forging Plant

FDA Consent Decree 4/2015 to 4/2016

Consultant, SME Senior Manufacturing Engineer – Facilities and Computer System Validation

• Assist client in determining Facilities requirements for manufacturing, temperature/Relative Humidity/compressed air (pressure, quality of air, other gases if any), electrical monitoring that may impact either components awaiting assemble or test equipment that may be impacted by excursions from pre-determined electrical sags, surges or transients. Identify current gaps in adverse condition notification, rewrite Tier 2 and Tier 3 procedures to harmonize and update to current standards. Assist in determining appropriate systems for monitoring critical parameters, assist in the procurement during vendor interviews, manage and coordinate temperature/RH survey for manufacturing area (48,000 ft sq area) and other locations that may be used to store components that have carryover desing requirements after assembly and provide recommendation for the generation and execution of validation documents for manufacturing areas and warehouse areas. Participate with client management in executing audits of manufacturing and warehouse areas for cGMP compliance in preparation for known FDA upcoming audit of facility.(med DEV.clean room env.)

REGS Solutions- Anderson, SC 1/2017 – 2/2017

Consultant, Medical Device processes and software compliance

• Evaluate client’s quality system, processes and software for a new product in the medical device field for compliance to applicable cGMPs and standards. This included a review of all work processes (Work Instructions, Manufacturing Procedures, Rework Procedures, Device History Records, Process Routers, etc.) for accuracy, content, identification of materials and identification of tooling. Compliance of software used for the device system components and for equipment used in the process for testing functionality, laser etching label information, power testing, and final testing for all components.

Osmotica Pharmaceutical- Marietta, GA 9/2016 – 10/2016

Manager, Commissioning, Qualification and CSV Compliance

• Ensures quality and regulatory requirements associated with the implementation and maintenance of GxP facilities, utilities, equipment, and computerized systems in achieved. Provide Quality Compliance oversight for GxP activities, review CQ&V documentation, analyze plans, make recommendations, review and disposition of related deviations/CAPAs. Work to improve the quality system from movement from a clinical trials manufacturer to a commercial manufacturer of clinical trials solid dosage products for timed release of API. Provide QA oversight for Enterprise AX Integration upgrade and for the implementation of EdgeTrac to serialize product and track the product through the supply chain as the company moves from clinical trials tablet manufacturing to commercial tablet manufacturing operations.

ProPharma Group- Kansas City, KS 10/2016 – 9/2016

Principal CSV SME

• Providing CSV validation services to a medical device company in an expansion project with the addition of clean rooms, facilities and utilities. Specialized equipment that have provided software validation documents include Keyence measurement system for product release and a new purified water skid that will provide purified water to equipment in a new cleanroom, sanitization methods will include hot water sanitization and ozone sanitization. Other equipment includes laser cutters, laser etchers, jar leak testers, ovens and an autoclave.

• Provide CSV consulting services to clients and support the business development of the company.

• Provided quality system development for a client that will provide serialization for finished packaged products and track the products through to the client’s distribution centers.

• Edwards Labs- vlean room Med Device assy env.

Meridian Medical Technologies- St. Louis, MO 5/2015 – 7/2015

Senior Validation Engineer

• Develop specifications document and then create IQ and OQ documents for a new packaging line for EpiPens for the Cartoner and Casepacker. Include computer system validation elements (CSV) into the Equipment System Design document as part of a new initiative to document, machine control integration utilizing a Systech vision system to distribute Lot No./Exp Date information to all labelers. Identify all configurable subsystems and software to create baseline for maintenance purposes. Create validated pathways for future implementation of product serialization and component aggregation.

Vention Medical-San Jose, Costa Rica 3/2015 – 3/2015

Senior TMV Engineer

• TMV, provide technical services for a medical device contract manufacturer. Review approximately 50 products and determine level of TMV required for product release. Evaluation of existing and new work instructions, PFMEAs, Device Master Records to verify the quality release documentation was in accordance with regulatory requirements in generating new test method protocols. TMVs were scheduled based on priority as execution was to be done by local staff.

• MED DEV.clean room assy. Contract manufacturerEnvTMV for product release.

Thermo Fisher/Maetrics- Frederick, MD 12/2014 – 12/2014

Senior CSV Engineer

• Provided technical services for a multi-function team that will determine the current level of validation of equipment and facilities. Part of a 4 person team to evaluate compliance within facility and corporate policies in preparation for an extended gap analysis and update of SOPs in advance of an upcoming FDA site audit.

Med dev. Shipping center,clean room env.

DePuy Synthes- Elmira, NY 9/2014 – 11/2014

Senior CSV Engineer

• Provide CSV services to write remediation documents for precision measuring equipment used in final inspection on medical devices. Gap analysis and SOP generation for next phase of procedure upgrades by new owner.

• MED DEV manufacturing center machine tool equipment CSV.

Raland Compliance Group- Rochester, NY 3/2014 – 7/2014

Senior CSV Engineer

• Provide engineering and validation services for a client preparing to enter the contract manufacturing of clinical trials pharmaceuticals (tablets). Evaluate system for transmitting data from tablet production line to engineering repository. Determine gaps in system architecture, connectivity (different buildings on site) and lack of detailed design documents for the system build and current operation. System required extensive URS/FRS/DDS document development prior to developing a validation plan to enable client to use production data for engineering and quality purposes.

CSV data repository for client-tablet manufacturing.

Novartis- Parsippany, NJ 11/2013 – 2/2014

Senior Quality SME

• Review and ensure quality documents generated by a designated contract packaging company to ensure co-packer followed all internal operating procedures and the procedures required by Novartis, prior to QA approval. Tasked to preview all validation documents involved with the product transfer of about 150 products. Reviewed and documented gaps for protocols submitted for approval to execute and review all document packages submitted after execution to verify adherence to Novartis SOPs.

Solid dosage co-packer validate manufacturing processes.

Hospira- Rocky Mount, NC 9/2012 – 6/2013

Regulatory Compliance Manager

• Work with the Regulatory senior manager to guide the external audit team in following the new SOP specifying how to respond to a Regulatory Commitment CAPA. Reviewed all CAPAs related to regulatory audits, determine gaps and identify to senior management team for follow-up activities. Coached individuals to ensure correct interpretation of CAPAs by reviewing CAPA plans and cross referencing with the agency audit notes to verify response will answer regulatory observation. Ensure follow-up action met the intent of the observation and that a review to verify the corrective action was effective was identified and put in place. Create SOP for Compliance Group to assimilate CAPA objective evidence in a document that could be reviewed by the regulatory body when returning to the site for the next audit. Develop metrics to visually display progress in CAPA plan development on a monthly basis where the annual CAPA response for the current year went from approximately 20 + CAPAs per year to 160 CAPAs per year.

Observe processes and identify gaps to program manager,voal production-clean room env.

Hospira- Rocky Mount NC 5/2012 – 9/2012

Regulatory Compliance Manager

• Review all documents related to recent FDA audits and review copies of communications to the Agency from the Rocky Mount site and the Chicago corporate headquarters to verify commitments made to the Agency. Evaluate all responses to the observations (CAPAs) by Hospira to ensure that the action met the intent of the observation.

• Observe processes and identify regulatory responses gaps to program manager,voal production-clean room env.

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Hospira- Rocky Mount, NC 2/2012 – 5/2012

Program Manager

• Provide remediation team support as a Program Manager (Subject Matter Expert) to Hospira (Pharma), Rocky Mount NC, working through Quintiles (FDA requested oversight support).

St Jude Medical- Plano, TX 7/2011 – 2/2012

Senior Quality Engineer/SME Test Method Validation

• Provide remediation team support as a Senior Quality Engineer (Subject Matter Expert) to SJM to investigate existing testing and determine status of inspection with respect to test methods and test method validation.

• MED DEV,clean room env.

Stryker Instruments- Kalamazoo, MI 7/2009 – 7/2011

Process Auditor/SME Process Remediation

• Provide audit team support as a Senior Process Engineer (Subject Matter Expert) to supplier audit team as Stryker Instruments responds to FDA issued 483. Other responsibilities included analysis of existing Stryker plant production processes, identifying gaps related to production and defining remediation plans, providing technical assistance to suppliers to develop quality systems and institute basic validation (OQ-OQE, OA-P, PQ) to bring those companies up to the current Stryker requirements. Map processes to determine which parts of the process required additional validation.

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• Audit team – assigned backlog of CAPAs to reduce number of outstanding CAPAs. CAPAs were assigned as they were entered into the system. Each CAPA had to be verified, then analyzed for appropriate corrective action, the corrective action executed if it did not deal with on-going vendor audits. In the event that did affect an on-going audit it was reassigned to the appropriate Process SME. CAPAs affecting audits that I had sole responsibility for were reassigned for action to close out the CAPA. This activity continued for approximately six (6) months until the CAPA backlog was reduced to levels that could be handled by the full time staff.

Teleflex Medical- Research Triangle Park, NC 5/2008 – 6/2009

Sr. Validation Consultant/Remediation Site Lead

• Completed Site Master Validation Plan, revalidated sterile packaging process for sutures, validated cleaning process for clips and staples, wrote CSV documentation for machine tools to be transferred to other manufacturing sites. Led team to map processes, categorize equipment and gaps associated with current validation to allow for validation at new location. Completed all site CNC equipment

GE Healthcare – Surgery- Lawrence, MA 6/2007 – 3/2008

Sr. Validation Consultant

• Provide CSV methodology to create documents for the validation of CT/X-ray (scanner) surgical guidance systems currently under FDA Consent Decree. Develop test protocols for InstraTrak 3500 system software. Assist Manager – Test Equipment with the development of procedures necessary to control and validate test equipment/tools used by the Lawrence Validation and Verification Team. Map testing processes for protocol generation. Establish requirements for validating electronic records for the DICOM datasets and for the electronic files used with the system receivers and transmitters. Teach team members, and team lead, current compliance requirements in the development of validation documentation.

Boston Scientific- Spencer, IN 12/2006 – 6/2007

Sr. Validation Engineer / Test Method Validation Team – Team Lead

• Manage team resources to plan, implement and execute approximately 65 projects to an aggressive schedule to meet BSC’s site remediation requirements. Responsible for training, coaching and guiding team members consisting of contractors, defined term employees, student coops and permanent BSC employees in developing solutions for completing the remediation effort. Map processes to evaluate product release requirements for test method validation.

• MED DEV.Observe processes and identify gaps to program manager,voal production-clean room env.TMV.

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Boston Scientific- Spencer, IN 7/2006 – 12/2006

Sr. Validation Engineer

• Develop test methods and test method validation documents for medical device products. Recommend, purchase equipment, train employees as Subject Matter Expert for method validation. Evaluate, analyze data and make recommendations for means to validate product/process for component /assembly applications in a fast track environment to support timeline expectations in meeting Warning Letter requirements.

• MED DEV.Observe processes and identify gaps to program manager,voal production-clean room env.TMV.

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Genentech- Oceanside, CA 6/2005 – 6/2006

Sr. Validation Consultant

• QE management requested continued support after the transition from the Biogen Idec facility to the new owner, Genentech (NIMO). Review legacy LIMS system, summarize gaps for recommendation for system revalidation, co-write gap analysis, validation project plan and other SLC documents.

• Aseptic env.convert from biogen –idec GENENTEC breast cancer drug,2 15,000 Trains.

,black label drug to

Biogen Idec- Oceanside, CA 2/2005 – 6/2005

Sr. Validation Consultant

• Review/advise/recommend changes to SLC validation protocols for Siemens APOGEE BMS unit for new bio-processing facility in Oceanside, CA. Documents reviewed included SOPs, U/FRS, DDS, IQ/OQ/PQ, Trace Matrix, Close-Out Reports and other support documents for compliance with Electronic Record/Electronic Signature compliance for the Quality Engineering department.

KV Pharmaceuticals- St. Louis, MO 6/2004 – 10/2004

Validation Consultant

• Generate and execute validation documents for an NDA/ANDA electronic publishing management system (EZsubs®), a server based system, that included; requirements review, an Installation Qualification, Operational-Performance Qualification (OPQ), Trace Matrix, Close-Out Reports and other support documents. This is a web based server system that had to be validated on a fast track schedule. Vendor documentation included a User Acceptance Test and functional Operational Qualification scripts that were used in the overall validation activity.

Med DEV,clean room env.

DSM Biologics- Montreal, Canada 7/2003 – 2-2004

Validation CV Project Manager

• Evaluate existing computer systems and documentation for recommendation of either using the existing systems or replacing them to meet current cGMP and CFR 21 Part 11 issues. Responsibilities included providing comments for the Quality Initiatives, the Validation Master Plan, the Computer System VMP, VPs, SOPs and strategies to bring the facility into a higher level of compliance.

Aseotic contract sterile manufacturer.Facility gap analysis for client to determine scope of work necessary fo client’s product and level of compliance to FDA.

MedImmune Pharmaceuticals- Frederick, MD 3/2003 – 5/2003

Validation Consultant

• Reverse engineer SLC documentation for a software reporting system (TrackWise® - a Sparta Systems product), server based system, to generate an Installation Qualification protocol, a Detailed Design Specification and the Operational Qualification protocols for the testing of the system. Map the process for documentation workflow in preparation of design documents. This is a software based system, with Electronic Record-Electronic Signature requirements, designed to operate on the Owner’s server and support product complaints from multiple sites through the company’s Intranet and Internet.

Non-aseptic- clean room env.

Bayer – Pharmaceutical- Clayton, NC 9/2002 – 2/2003

Validation Consultant

• Reverse engineer System Life Cycle documents for the facility’s Andover Building Management System. Project required the development of comprehensive Functional Requirement documents for all of the air handlers and several units of support equipment used in the plasma fractionation process. This included review of Detailed Design Specifications, software code, drawings and interfacing with the line personnel to assure identification of cGMP functions. Test Scripts in the form of Installation/Operational Qualifications were generated to test all noted Functional/Design requirements.

Blood fractionation facility-Aseptic env.

Millennium Pharmaceuticals- Cambridge, MA 4/2002 – 6/2002

Validation Consultant

• Responsibilities include the reviewing of specifications, design documents, test documents, writing the test scripts for the PLC protocols. Assisted other validation consultants in developing test scripts for the SCADA system by writing the screen navigation and the testing of the Electronic Record/Electronic Signature portions of the SCADA protocol. This was a hyper track project that was executed, and completed within the client’s schedule, against an aggressive startup schedule.

Aseptic,barrier technology, 4x8 modules (bag technology)for each phase in a contract sterile mfg facility-validate.

PLC controlled process for proprietary product

Eli Lilly Company- Indianapolis, IN 7/2001 – 4/2002

Validation Lead

• Computer validation services for the restart of a pilot plant facility. Responsibilities include the writing, reviewing and approval of validation plans, specifications, design documents, test scripts and other deliverables required for Life Cycle compliance. Managed two (2) teams to develop standards and audit checklists for vendor audits for PLC systems/SCADA systems and source code reviews for PLC and DCS systems. System provided real time information to management so manufacturing process could be closely regulated

• Directed the work of two (2) platform engineers a technical writer and coached the newly hired Automation Engineer on cGMPs compliance issues.

Merck & Co- Wilson, NC 3/1997 – 8/2000

Senior Project Engineer/Validation Engineer

• Responsible for the purchase, installation and validation of a high speed trade bottle packaging line and a high speed sample bottle packaging line as part of a site expansion project. Responsibilities included writing equipment specifications, System Life Cycle (FRS, DDS, Equipment IQs/OQs, CVIQs/CVOQs) for fillers, weigh cells, cappers, labelers, case packers, case shippers, visions systems, Factory Acceptance Tests and IQ/OQ test scripts.

• Both packaging lines were started on time and under budget.

• Senior Packaging Engineer/Validation Engineer

• Provided services for the blister packaging operations, new tooling, with validation, operation and repair of blister machines.

• Developed software functional testing of new and existing equipment when the equipment manufacturer did not make information for software structural testing available.

• Assisted client’s principal blister packaging engineer in the moisture vapor testing of several new products by; writing the respective documents, supervising the execution of the testing, supervising the collection of the samples and direct shipment of the samples to the laboratory for analysis.

Sterile aseptic env.,B135 conversion to Cialis.building automation validation.

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