Alan P. Herman

ad2q2l@r.postjobfree.com

202-***-****

Sr. Validation Engineer-Lab, BMS, Manufacturing (MES), Pharmacovigilence Automation, Data Integrity

Summary:

Senior Validation Engineer and project manager with programming, qualification, commissioning, qualification, auditing, validation, disaster recovery/business continuity, gap assessment and remediation of laboratories, pharmacovigilance, automated processing, manufacturing, packaging, labeling, laboratory, clinical, distribution and drug safety systems within regulatory environments of pharmaceutical, medical device and biopharmaceutical industries.

Trained by the FDA as an Auditor on 21CFR11 and Pharmacovigilance areas of compliance. Performed as an FDA Auditor for inspections and audits of pharmaceutical companies in the US, Netherland, Ireland, UK and Germany.

Experienced in assessment and remediation of Part 11 compliance within all areas of labs, facilities and manufacturing.

Performed numerous internal and external audits concerning Pharmacovigilance for US and International Subsidiaries ensuring compliance with both FDA and EU regulations.

Performed commissioning of laboratories, validation of lab equipment and LIMS data collection installation and validation.

Expert in the full validation lifecycle of FDA regulatory systems including computers, PLCs, manufacturing, laboratory, packaging, labeling (creation and validation), serialization, warehousing (including distribution, clinical and Pharmacovigilance areas. Includes creation, review and approval of protocols and procedures to ensure compliance with QSR, QMS, GLP, GMP, GPvP, GCP, GXP and other FDA, MHRA, ISO and GAMP regulations.

Experienced in validation, development, change control and programming of process automation control systems.

Experienced in the review and remediation of full SDLC validation lifecycle documents for client/server, ERP (Oracle and SAP), stand-alone and mainframe systems utilized in the areas of manufacturing, warehousing, drug safety, clinical &labs.

Superior interpersonal skills that ensure delivery of fully validated and compliant systems through the emphasis on a team environment approach, ensuring delivery of protocols and procedures within time constraints and under budget.

Diverse skill-set encompassing every role within the complete lifecycle of both SW/HW systems.

Technical Skills:

PLC’s / Automation Systems: Allen-Bradley, Fisher, Foxboro, Emerson, DELTAV, FactoryTalk, Data Historian (SE and ME), Siemens InfoCenter1.6.5, Siemens Insight 3.1.2; Cognex InSight D900, Honeywell

Lab Equipment: ABI, Agilent 2100 Bioanalyzer, Biomek NXP Bioassay robotic workstation, Beckman / Coulter, Cole-Parmer, Convergent iCE280 Analyzer with PrinCE Microinjector, iCE280, Hyperion, Royco, Corning, Fisher Scientific, Mettler-Toledo, DCS20, TC15, STARe, Waters HPLC, Thermo Spectronic, Thermo Electron, Labconco, Crescent HPLC, HBLT, FTIR, Applied Biosystems Real-Time PCR, NICOLET Avatar, Perkins-Elmer, Forma-Fisher freezers, Perkins-Elmer Atomic Absorption Spectrometer, Instron, Labware LIMS, Brinkmann Tuttnauer autoclave, Nautilus LIMS, Waters Nugenesis LIMS, Cognition Cockpit, SampleManager

Manufacturing / Packaging Equipment:

Pneumatic heat sealers, Tablet fillers, Powder fillers, Thermoformers, IPC injection molders, PPE manufacturing, scan-code inkjet printers, MES, Heidelberg offset printing presses, USP Purified Water, Water-for Injection, Tyvek sealing, granulators, label printers, serialization, EFD glue dispensers, heat guns, case sealers, driers, external coating machines, burst testers, ovens, water baths, freezers,

Standards/Methodologies: FDA, cGMP, cGLP, cGCP, cGXP, cPvP, ANSI/ISI 95, 21 CFR 11, 21 CFR 58, 21 CFR 210, 21 CFR 211, 21CFR 111, 21CFR 820, 21 CFR 4a, 21 CFR 201, 21 CFR 314, and 21 CFR 601, ASTM E2500, MDD 93/42/EEC, ICH, ASME, ASTM, ISPE, ISO900x, ISO3270, ISO13485, ISO14971, IEC 62304, CE Marking, MDD 93/42/ECC, GAMP4/5, ISEE, Mil Std 2167a, DoD, SOX, HIPAA, EMEA, eIND, IEEE828-830, 1012, 1016, 1028, 1074, ALCOA, RUP, RAD, CMM, SDLC.

Platforms: MVS, VM, VM/SE, VM/SP, VAX, DOS, Windows 3.5/95/98/NT/2000, OS/2, AS400, Sun Solaris, BEA Systems, UNIX, AIX, MAC, CP/M, HP1000, HP2000, Macintosh, DATASYM, Apple, Oracle, VMware

ERP: SAP R/3 R4 (MM, PP), Oracle 11i (BOM, WIP, ENG, PO, INV, DM, QM, PM, etc.)

Databases: Sybase, Dbase. DB2, Oracle, SAP, MS SQL Server, (also w/ SQL, SQL/DS, etc), Oracle R12

Hardware: IBMxx (most all mainframes and mid-frames), CISCO, SUN SOLARIS, SUN OS, Apple, Macintosh, CRAY, Kodak, Ericsson, Motorola, Lucent, NTI, AS400, Sharp, TEC, MICROS, PS/2, SWEDA, TOSHIBA, Dell, HP

Applications: Project, Word, Visio, Excel (w/macros), Access, Reflections, FactoryTalk, Rs Powerpoint, Expressions, Outlook, Project, Publisher, Documentum, TrackWise, NetMechanics, Interdev, ASP, FrontPage, HP Quality Center, VBScript, SiteLoad, Remedy, WinRunner, LoadRunner, QA Partner, Rational Test Suite, Test Director, File-AID, TCP/IP, RACF, WYLBUR, JCL, TSO, ISPF, CP, CMS, E, PE2, File-Aid, PVCS, CMM, VB, VM/SP, HTML, SGML, SCRIPT/VS, GML, ISIL, CGI, SS, SRS, IRS, PIS, GroupWise, Reflections, SQL, OfficeVision, Lotus Notes, PageMaker, PIPELINES, APPC-LINK, CorelDraw, FreeLance, PITS, RETAIN, HONE

Experience:

The Pharm Bureau ( December, 2019 – Present). Senior Validation Engineer

Developed automated program that took requirement (URS, FRS, SRS, etc.) for SDLC validation for pharmaceutical and medical devices that included 21CFR11 assessments, GMP assessments, regulatory compliance assessment, IQ, OQ and PQ protocols, Relative Traceability Matrix and final summary report for release.

Lyophilization Services of New England (LSNE) (April, 2019 – September, 2019) [Contract position]

Sr Computerized System Validation Engineer

After gap assessment, developed remediation plan, helped develop SOP’s and remediation testing and validation to fill gaps.

Performed qualifications on MasterControl process modules for reporting, document management, audit management and BOM.

Validated the Blue Mountain Regulatory Asset Manager (RAM) software for customized asset management and calibration. Performed data integrity analysis (ALCOA) between FactoryTalk Data Historian and Lyophilization PLC’s.

Performed qualifications on OSIsoft PI system for data management and reporting.

Performed commissioning of fill and bagging equipment, as well as dosing and recipe modification.

PharMEDium, Lake Forest, Illinois (February, 2018 – February, 2019) [Fulltime position]

Sr Validation Engineer, Analytical Laboratory Validation Engineer

After certified training in Data Configuration of ThermoFisher SampleManager LIMS, developed user and functional requirements and wrote validation protocols for compounding laboratory samples measuring Endotoxins, potency, pH, sterility and visual purity.

Performed gap assessment, remediation and qualifications of clean rooms, incubators, freezers and compounding pumps.

After risk assessment and analysis, performed process validation of ASC/PULSE software updates and wrote PPQ verifying compounding of narcotics into bags/syringes, with USP Water-for-Injection, through labeling, packing and shipping of product.

Performed data integrity between RSLogix ladder logic, incoming data from PLC’s and FactoryTalk Data Historian.

Developed rationale in responses for 483’s and worked to plan and mitigate these deficiencies.

The Pharm Bureau ( December, 2017 – Feb 2018). Senior Validation Engineer

Developed Validation templates and marketing presentations.

Adello Biologics, Chicago, Illinois (November, 2016 – September, 2017) (Contract position]

Building Automation Validation Engineer

Upon gap assessment, developed a remediation plan and wrote IOPQ for the Siemens Building Automation/Management System (BAS, BMS) for clean suites containing biosimilar laboratories, manufacturing w/MES, packaging, and warehouse suites.

Performed validation and data integrity of the BAS/BMS for clean suites containing laboratories, manufacturing, packaging, and warehouse suites, USP Purified H20, Qualified Pressure, Humidity and Temperature sensors as well as Differential Pressure. Ensured all servers met IOPQ to required specifications. HP QC used in reporting and in qualification trending and FactoryTalk.

The Pharm Bureau, Chicago, Illinois (February, 2016 – November, 2016) [Contract position]

Sr Validation Engineer, Validation Template Designer

Created initial Validation templates, policies and procedures for upstart Validation Company.

Phillips Medisize, Menomonie, Wisconsin (July, 2015 – January, 2016) [Contract position]

Senior IT/QA and Manufacturing Validation Engineer / Business Analyst

Qualified and commissioned a customized robotic swaging station for a distal subassembly manufacturing of an ocular implant device and a customized leak tester that verified swage success.

Validated a customized epoxy metering machine joining of ocular subassemblies. These activities covered user and functional requirements, design review and validation of the vendor.

Astellas Pharma, US, Norman, Oklahoma (September, 2014 – May, 2015) [Contract position]

Senior IT/QA Validation Engineer

Performed Validation of oral dosage N3 O’Hara Tablet Coater upgrade and of the Allen-Bradley Data Historian, MES and OSIsoft PI Servers for PLC’s that controlled pill manufacturing. documentation included URS, FRS, VP, IQ, OQ, PQ, TM and VS.

Kinetic Concepts, Inc. (KCI), [Acelity] San Antonio, Texas (January, 2011 – July, 2014) [Full-time position]

Project Manager / Senior IT/QA/CSV/Labeling/Laboratory Validation Engineer, Business Analyst

Performed internal audit of IT HW, SW, policies, procedures and GMP compliance. Created a Remediation Plan to cover all gaps.

Wrote, executed and released entire CSV validation packages (URS, FRS, VP, DS, IQ, OQ, PQ, TM, VSR, etc.) for many SW/HW systems, including: MES, LIMS, Avamar/Data Domain deduplication, data integrity, Pharmacovigilance/ADE systems, Cognition Cockpit, TrackWise, RoboHelp, iOS apps, and upgrades to VMware and Argus. HP QC tracked testing and project status.

Led validation, data integrity and commissioning of Waters Nugenesis LIMS application with ELN within the Quality Control Lab.

After development of business requirements, developed, validated and launched iOS apps for the order and delivery, as well as for nurses and field personnel to deal with adverse reactions for negative-pressure wound therapy medical devices (VAC therapy)

Human Genome Sciences, Rockville, Maryland (May, 2010 – November, 2010) [Contract position]

Analytical Laboratory Validation Engineer

Wrote and executed validation and quality protocols for the analytical laboratory instrument department.

Developed, executed and qualified the Biomek NXP Bioassay robotic workstation that automated pipetting for a bioassay lab.

Executed IOPQ and re-qualifications for densitometers, iCE280 IEF Analyzer, spectrophotometers, spectrometers and HPLC’s.

GOJO Industries, Cuyahoga Falls, Ohio (March, 2009 – January, 2009) [Contract position]

Pharmaceutical Manufacturing and Labeling Validation Engineer / CSV / Business Analyst

Performed requirement definition through validation of manufacturing lines for formulation of Purell sanitizing hand sterilizers, USP Purified H2O, including injection molding, robotic filling, capping, packaging, labeling, quality control testing, LIMS and warehousing. Use of automated vision systems were deployed during packaging and fill and went through IQ, OQ and PQ.

Performed validation of Zebra printers and verification of labels meeting 21 CFR Parts 201, 314, and 601.

In remediation of gaps, designed, built, qualified and commissioned a Level 5 clean room using ASTM E2500 methodologies.

Performed validation for the HVAC and Ventilation System installation for a Fill and Capping Room

Arrow International (Flextronics), Asheboro, North Carolina (May, 2008 – August, 2008) [Contract position]

Project Manager / Manufacturing / Labeling Validation Engineer / Business Analyst

Performed packaging, labeling, injection molding and serialization analysis for all product trays, PPE gowns and sterilized pouches manufactured.

Managed Validation of clean rooms, sterilizers, extrusion and injection molding and development of new extrusion tooling.

In response to a 483 for packaging, performed remediation of known gaps through complete ink and paper seal analysis to find incompatibilities that led to sterile closure problems of the Tyvek label, due to printing Tyvek with higher oil solubility ink.

Rewrote all ink specifications, procedural and processes to correct solubility issues and ensure the integrity and life of the seal.

Purdue Pharmaceuticals, Stamford, Ct. (September, 2007 - November, 2007) [Contract position]

External Auditor (Pharmacovigilance / Drug Safety)

After review of past 483’s, EIR’s and CAPA responses, performed a thorough external Audit in the areas of Pharmacovigilance that included ADR’s, AE’s, DCR’s and all cGCP and cGMP areas for worldwide pharmaceutical group

Audit covered every facet of ADE reporting to the FDA through MedWatch and PSUR and all related quality areas, including ADE and Complaint collection and submission databases, patient privacy, training, ERP documentation review, TrackWise, records management, document management, SOP’s, validation documents, periodical review procedures and all ADE areas.

Gap remediation regarding adverse drug reactions and adverse events reports, included re-training on coding of medical information of the electronic transmission of individual case safety reports (ICSRs) using MedDRA, an electronic training records corporate-wide database, handling of MedWatch adverse events reporting through the MMP, resolution of data transmission and data center security concerns, and re-engineering of the Argus database system to ensure HIPAA compliance through HP QC.

Biogen Idec, Cambridge, Massachusetts (September, 2006-April, 2007) [Full-time position]

Computer System Validation Engineer / Laboratory Validation / Drug Safety / Business Analyst

Performed internal audit on drug safety reporting and Argus database validation protocols and developed remediation plan to ensure compliance with cGMP, GAMP, FDA, HIPAA, ICH, WHO, EMEA and NCA directives, such as 2001/82/EC, 2001/82/EC, 2004/726EC, etc. and Pharmacovigilance reporting through the EVWEB and MedWatch utilities.

Wrote the DQ, IQ, OQ, PQ and process validation for two ABI Prism 7900HT Sequence Detection Systems for installation, commissioning and qualification in new QC Virology lab and the real-time Polymerase Chain Reaction (PCR) systems for the replication of DNA for viral clearance testing. Utilities included HVAC, Argon and Nitrogen gases and Clean Compressed Air.

Validated aseptic CIP and SIP processes, oral dosage and installation of Nautilus LIMS and data integrity of all data transmitted. Wrote Disaster Recovery and Business Continuity Plans, gap assessments/remediation, Pharmacovigilance and cGMP, cGCP.

Boston Scientific, Maple Grove, Minnesota (May 2004-August, 2006) [Contract position]

Drug Safety / Manufacturing, Packaging and Labeling Validation / Business Analyst

Worked with deviations, complaint handling, CAPA response, change management and Argus reporting and validation and remediation of risk management activities, to meet with ISO 13485 and EEC decrees and QMS certification.

Performed gap assessment of ERS reporting and developed remediation plan to close all gaps.

Upon gathering of requirements, performed quality reviews, analysis and correction of validation documentation, procedures and processes for the commissioning of automated catheter and stent manufacturing lines utilizing LaserMike visual solutions. Document reviews encompassed full V-model SDLC implementation (URS, DS, MD, UT, IT, FS, IQ, OQ, PQ, TM, IOP/QR through acceptance and commissioning.

Upon writing of user and functional requirements, performed total process and data integrity validation for the over-the-rail Apex manufacturing line, including wire prep, laser cutting, finishing, crimping, film coating, dipping and balloon, packaging, labeling and serialization stations. Also, included in this was the quality control laboratory LIMS system and ELN solution.

Mentored Junior Validation Engineers to understand the corporate policies and procedures and the associated FDA and Euro regulations.

Cordis, Miami Lakes, Florida (August 2004-May, 2005) [Contract position]

Sr. Validation Analyst / Quality Assurance / Business Analyst

Performed site-wide inventory of all computerized systems, followed by an extensive audit and gap analysis of all systems, ensuring compliance of 21CFR11 standards, Pharmacovigilance and internal Quality and Compliance programs.

Performed Computerize System remediation (CSV) for all hardware and software systems after gap assessment.

Implemented policies, procedures and processes to ensure compliance with FDA, SOX, EU and CE marking regulations.

Wrote and executed IQ/OQ/PQ protocols for lab equipment, including Instron, Waters and ThermoFisher equipment.

Led the validation of Labware LIMS modules in a lab containing multiple FTIR’s and HPLC’s, as well as other equipment.

MedImmune, Frederick, Md. (May 2004-August, 2004) [Contract position]

Project Manager / Quality Assurance / Laboratory Validation Analyst, Manufacturing, Packaging and Labeling

Managed the writing and execution of IQ/OQ testing for Clinical Laboratory HPLC and FTIR calculation spreadsheets and CIP/SIP system. Performed gap analysis of spreadsheet validation protocols for multi-site remediation.

Managed the development, writing and implementation of the Multi-Site SOP for Validation of Spreadsheets.

Developed, wrote and executed IQ’s, OQ’s and PQ’s for the validation and calibration of lab equipment, freezers, sterilization, Building Automated Systems (BAS), manufacturing lines, injection molding, packaging, labeling and warehousing with entry into TrackWise.

Rockwell Automation, Indianapolis, Indiana [Fulltime Position]

Roche Diagnostics, Fishers, Indiana

Validation Manager – Laboratory / Manufacturing/ Packaging (December 2002 - May, 2004)

Managed six member team on the internal audits and gap assessments of AE reporting and CAPA procedures (including CRM), all related systems, including ERP policies and practices, staff education and training and documentation.

Performed assessment and validation on the clinical device safety platform and the Argus reporting system.

Developed requirements,21 CFR Part 11, GAMP, cGMP, cGCP and cGLP gap assessment and remediation for the Laboratory, Manufacturing, Packaging, Injection Molding, Labeling and Clinical Studies of a medical device (Accu-Chek diabetic testing unit). This included details from receipt of original materials (incoming agents and raw materials) through automated manufacturing, clinical testing, warehousing validation, robotic manufacturing and adverse reaction reporting.

Performed IQ/OQ/PQ of warehouse datalogger pucks and system software, as well as gap remediation of procedures.

Eli Lilly, Indianapolis, Indiana

ProjectManager - Manufacturing Validation and Test (April, 2003 - December, 2003)

Led 7-member team for the definition of requirements, analysis, compliance audit, gap assessment, remediation and validation of diabetic manufacturing unit, including warehousing, laboratory and shipment of product, FactoryTalk TrackWise gap reporting, deficiencies and discoveries for 62 process automation systems, including Allen-Bradley, Emerson and DeltaV.

Reviewed and re-engineered processes that included SIP, CIP, washers, mixers, powder fillers, and temperature control collection units, Statistical Process Control (SPC) boundaries, Metasys and others. Wrote FDA Audit Preparedness Manuals covering FDA compliance, physical/logical security, training, change history, calibration, periodic reviews, IQ, OQ and PQ.

Allen-Bradley, Cleveland, Ohio

Automation PLC Engineer (December 2002 – April, 2003)

Programmed SPC’s, RSBatch recipes, ladder logic, limits, boundaries and all specific robotic details defining scope of compliance within PLC parameters using RSLogix. The parameters monitored temperature, viscosity, flow, time, etc.

Developed tools that precisely performed validation meeting both Lilly and GAMP compliance, as well as provide costing estimation for remediation of those areas found non-compliant.

ELANCO, Clinton, Indiana

Validation Manager - Automation/Manufacturing/Labeling (June, 2002 – December, 2002)

Developed and performed mock audits and training for system owners for drug safety reporting, related databases and networks, CGMP, CGLP, protocols, procedures and system security in preparation for upcoming scheduled fda audit.

Performed requirements gathering, validation, auditing and gap assessment of animal nutraceutical for swine (paylean and paylean with tylosin) that led to the remediation plan and changes of policies, procedures and re-validation of the Manufacturing, packaging and labeling lines of production utilizing Cognex machine vision systems, sensors and barcode readers to meet compliance with 21CFR111 regulations. This included strict guidance’s to identify HACCP critical points and limits and monitor these points with process controls and WI’s.

Defects were prioritized into severity ratings, covered gaps found and defensible responses to FDA and USDA. Areas covered included manufacturing, facilities, packaging, injection molding, warehousing and distribution and covered training, quality processes, procedures and policies, system inventories, metrology, HVAC, differential pressure, CIP/SIP, Data Historian, LIMS, etc.

Eli Lilly, Indianapolis, Indiana (March, 2002-June, 2002)

Senior Systems Validation Lead

Performed an extensive internal audit on a multiple sepsis drug (Xigris®) baseline that included process automation, computer, laboratories and end-user systems SCADA systems and Wonderware. This was used to layout a precise remediation plan to close all gaps.

Federal Trade Commission [FTC], Washington, DC 1999-2000 [Contract position]

Project Manager - Disaster Recovery / Business Continuity

Performed complete audit of every office, computer system, application, and complete infrastructure for each employee and office within the FTC to audit the processes and procedures in place to perform risk-analysis and gap remediation within federal guidelines to prepare for potential Y2K disaster. These findings were then reported each morning in a face-to-face meeting to the Federal Trade Commissioner.

Food and Drug Administration [FDA], Rockville, Maryland 1999 [Contract position]

Pharmaceutical Auditor

Trained by the FDA, performed auditing, analysis, process and procedural validation, verification and reporting of system, laboratory, manufacturing and product compliance after meeting with CEO’s and upper-level management personnel of major pharmaceutical and medical device manufacturers in the United States, the UK, the Netherlands, Ireland, Germany and EU.

Toured and audited plants performed thorough audit analysis of all processes, policies and procedures for manufacturing, laboratory and clinical procedures to ensure that standards and implementations were in place to meet 21CFR11, Y2K readiness, FDA and industry regulations and standards. Coverage areas included laboratories, automation systems, computer systems, product development, manufacturing, warehousing, order processing, distribution requirements and reporting.

Wrote extensive summary Audit reports and sent to FDA where they were compiled for reporting to Congressional Hearings encompassing the overall status and readiness of the pharmaceutical industries during Y2K, and the industry status of 21CFR11.

Federal Deposit Insurance Corporation [FDIC], Arlington, Virginia 1999 [Contract position]

Program Manager

Conceived, designed and managed the development of a 12 member team for an Intranet-based application, Systems and Applications Developers Interface Enterprise [SADIE]. SADIE provided automated processing between the developers of Internet-based systems and applications, and the Internet Unit, CM, Security and CEO of the FDIC. SADIE is still in use today.

National Institutes of Health [NIH], Silver Spring, Maryland September, 1996-October, 1997 . October-Contract position]

Project Manager

Led an 8 member team in the requirements analysis, system design and development of an Internet/Intranet site for the National Heart, Lung and Blood Institute (NHLBI) and Center for Disease Control (CDC). The entire system, sub components and processes were designed, validated and documented to ensure compliance with FDA, SEI and ISO.

American Red Cross (ARC), McLean, Virginia October, 1995 – July, 1996 [Contract position]

Project Manager / System Validation Lead / Labeling Validation

Managed 8 member team for an FDA regulated software system, NBCS, responsible for the processing, packaging, shipping and tracking of the donation, collection, validation, accounting, distribution and control of nation’s blood supply.

Upon gap assessment, wrote remediation plan and validation of Zebra label printers, including label specifications for the blood bags per ISBT 128. ARC Labels identified donor ID #, ABO/RhD, product code and date and time of collection and expiration.

Led validation effort for system development, laboratory procedures, architecture, processes and procedures to meet ARC, FDA and ISO standards. Upon discovery of compliance issues, false reporting of validation progress (98% vs 62%), and other reported issues, shutdown and redesign of entire project was performed, thus saving integrity of the blood supply and of human l

National Institutes of Health (NIH), Bethesda, Maryland February 1994-October 1995 [Contract position]

Internet Development Leader / Systems Validation

One of four co-leaders that brought the U.S. Governments only first active Internet web site (www.NIH.gov)

Provided level 3 technical support for Internet development, statistical packages (SAS, SPSS, etc.), quality assurance, client-server, technical writing for all of the NIH Institutes and related community (BLS, HUD, BLM, CDC, etc.), programming, imaging and communications (TCP/IP, FTP, ATM).

Performed requirements analysis and documentation for an epidemiological study for chemical plant personnel throughout the world the Worldwide Mortality Registry (WWMR), for CDC.

Education:

North Carolina Wesleyan, Rocky Mt., N.C.

Bridgewater College, Bridgewater, Va.,

Northern Virginia Community College, Fairfax, Va.

George Mason University, Fairfax, Va. “

Member: American Society for Quality (ASQ) and International Society for Pharmaceutical Engineering (ISPE)

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