John F. Cuspilich, Sr. Compliance Instructor / Auditor / Consultant
PO Box 1696, Medford, NJ 08055  Tel: 856-596-2333 Fax: 856-810-7339  jcuspilich@auditing.com

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Introduction: (Standard Excerpt)
“…over 30 years of hands-on technical and management level experience within the Pharmaceutical, Biotechnology, Medical Device, Petrochemical, Validation, and regulated industries worldwide.

Serving within various business units in Quality Assurance / Regulatory Affairs, Training and Development, Manufacturing, Research, Engineering, Technical Mechanical Departments, etc.., John has assisted many companies in meeting and exceeding regulatory compliance, pertaining to ‘for-cause’ or ‘due-diligence’ initiatives.  Assisting companies to achieve, resolve, remediate and exceed regulated industry requirements, mandates, ‘for-cause’ and ‘due-diligence’ priorities with the technique of promoting GxP standards and practices through interactive hands-on training.

John has extensive knowledge in industry standards; US FDA (CDER, CBER, CDRH, CVM, CFSAN), International cGMP, GLP, ICH, OECD, GAMP, ISO, OECD, OSHA, HACCP, HIPPA, EPA and GCP regulations and thorough knowledge in the process of implementation of these standards.  John also enjoys speaking and engaging with and at many of the Industry professional associations, seminars, and trade shows worldwide, conducted both on-site and off-site training seminars, and speaking engagements.


Medical Device & Software Qualification, Validation Expertise:

With over 20 years of extensive device, systems, and software audit experience, and has the insight that most electronic systems Auditors lack.  With firsthand experience, John has audited hundreds of software systems and companies world-wide in support of Good Validation Practice Standards, and PMA/510(k) Compliance requirements.  And as a member of the GXP Conference organization, John also conducts numerous conferences and seminars on Quality Systems Management, Computer Systems Validation and 21 CFR Part 11 Compliance requirements.

John has conducted over 800 on-site and desk audits in support of, but not limited to:

  • Good Manufacturing Practice requirements supporting Bio-Pharmaceutical Industry.
  • Good Laboratory Practice requirements supporting laboratory and testing services.
  • Good Clinical Practice requirements supporting clinical activities.
  • ‘For-Cause’ and ‘Due-Diligence’ audits
  • Quality Management Systems Audits - Medical Device Industry (FDA / EMeA / ISO)
  • Electronic Systems and Software Audits (21 CFR Part 11 / EU Annex 11)
  • Validation and Qualification Audits

Assists firms to meet compliance requirements by implementation of standards through;

  • Audit existing systems, software and attendant documentation
  • Development of Remediation and Resolution Plans
  • Development of Validation Protocols for Software and Systems
Development of validation, programming and quality audit procedures and standards

Areas of Expertise:

  • Compliance Auditor / Instructor – Regulated Industry Compliance Audits
      • Vendor, Supplier, Contractor, Consultant, GXP Audits.  Systems in support of GXP Activities.
      • Drug, Medical Device, Combination Products, Blood and Tissue, Laboratory and Biologics, Controlled Substance, Food and Dietary Supplements, Nutraceuticals, and Regulatory
      • Title 21 Code of Federal Regulations Auditing and Remediation Services
        • Parts 11 Electronic Records, Electronic Signatures; EMeA Annex 11;
        • Parts 58 Good Laboratory Practice; OECD General Principles
        • Parts 110 and 111 Food and Dietary Supplement GMPs
        • Parts 210/211 Drug GMPs/API Manufacturing
        • Part 820 Quality Systems Regulations – Medical Device
      • ‘Due-Diligence’, ‘For-Cause’ & 483 Site Audits and Follow-up Remediation Services
      • Mock FDA, WHO, EMeA Audits and Pre-Audit Inspection Preparations
      • GMP – PAI – GLP – GCP – ISO – ICH – OECD – Ethical – OTC – Manufacturing – R&D
      • GCP Pharmacovigilance auditing in accordance with 9a EU ICH requirements
      • Computer Systems, 21 CFR Part 11 ERES, IT, MIS Services, EDC, Clinical Systems and Data Capture (ASPs, ISPs and internal management systems, Site Remediation, ‘For-Cause’, (E2B), ISO 13485/14971, IEEE Standards. EU Annex 11 – 15.
      • Quality Management Systems / Quality Assurance, Part 820 QSR, QSIT, ISO 13485, ISO 14971, ISO 14644 Clean Rooms.
      • GMP Good Manufacturing Practice Audits (21 CFR Part 210/211, ICH Q7A) CAPA Management Programs and Methodology.
      • GLP Good Laboratory Practice Audits, 21 CFR Part 58, CLIA, OECD, Engineering, Facility & Validation, ISO 17025, Canadian 1510e Standard.
      • GCP Good Clinical Practice Audits (Clinical Process & Systems in accordance with 21 CFR Parts 50, 54, 56, 312, & 314, & 511)  Investigator, Site Monitoring, Pharmacoviligance, IND, AND, ANDA, BLA, PMA & 510k.  ICH E6 – ICH Audits (E2A/B). Good Data Management Practice.  Database auditing and programming standard audits.
      • CE Mark Preparation Audits support of WHO / EMeA Audits
    • Remediation Consultant – Audit remediation and project management
      • PAI – Site compliance
      • Post Audit Remediation – Resolutions – Deviations
      • FDA EIR 483 Remediation
    • Computer System Validation, Engineering, Development & Protocol Execution Audits
    • 21 CFR Part 11 Site(s) Remediation Initiative Project Management.  Global Standardization
    • Project Engineering – Pharmaceutical Facilities, Manufacturing / R&D
    • Facility Project, Maintenance, Engineering & Quality Management & Procedural Development
    • On-Site Training and Development – Customized training packages and presentations:
      • 21 CFR Parts 210/211 Drug GMPs
      • 21 CFR Parts 11 – Electronic Records; Electronic Signatures
      • 21 CFR Parts 820 – Quality Systems Regulations
      • 21 CFR Part 58 – Good Laboratory Practice – Toxicology & Non-Toxicology
      • Pharmaceuticals – Finished and APIs
      • Software / Systems Development Compliance Requirements under 21 CFR Part 11
      • Engineering and Validation Services
      • Food and Dietary Supplement GMPs
      • Laboratories (GLP Compliance under 21 CFR Part 58 – 42 CFR Part 493)
      • Manufacturing (Pilot and Full Scale)
      • Validation and Qualification – GAMP
      • Packaging and Warehousing
    • Center for Food Safety and Nutrition Website and GMP Discussions

1999 to Present : GMP Publications (GMP Publications – The Auditing Group and FDA.COM)

Work History:

  • The Auditing Group, Inc.  & Validations.com – October 2001 to Present
  • FDA.COM – May 2001 - Present – Site Moderator (Division of GMP Publications, Inc.)
  • GXP Conferences - January 2011 - Present
  • GMP Publications, Inc. – May 1999 to Present (Parent Company)
  • Senior Editor – GXPNews e-Newsletters

The Auditing Group, Inc. & Validations.com – Compliance Auditor and Remediation Consultant:

  • GMP, GLP, ICH, ISO, WHO & GCP Auditing and Remediation Consulting (800+ compliance audits)

(Forensics Compliance Contract Officer – Contract FDA CDER, CBER and CDRH Divisions.

    • Manufacturing, Research & Development, Clinical, Medical Device, Laboratories
    • Vendors & Suppliers, Consultants & Contract Manufacturer Audits
    • Audits for Bio-Pharma OTC, Ethical, Nutraceuticals, Chemical, Bulk API
  • Validation (Process, Facility & Equipment) Auditing Services
    • Process Equipment, Manufacturing, Utilities, Engineering
    • EDC, MRP, MMCS, LIMS, SCADA, PLC, DCS, Custom and COTS applications
  • Auditing and development of validation master plans for Computer Systems and Software including but not limited to:
    • SDLC, VMP, VPD development, user requirements and functional requirements
    • Design qualifications, including schemas, flow diagrams and data modeling
    • Installation qualifications, gap analysis, and component inventories
    • Operational qualifications, test script development, training and executions
    • Performance qualifications
  • 21 CFR Part 11 Auditing, Remediation & Computer Systems Validation
  • Auditor - Process, Manufacturing, and Analytical Equipment, LIMs, EDC, Clinical Data Management, SAE, AER, PLC, SCADA, etc.
  • Engineering (Design / Build Facility Audits), Software Programming and Code Management Audits, Maintenance and Technical Compliance Audits
  • ‘For-Cause’ and Due-Diligence Audits
  • Vendor and Supplier Qualification Audits
  • FDA Assisted Audits, Pre-FDA Inspection Audits and Clinical Trial Audits
  • Employee / Investigator Audits and Investigations (CV Audits)
  • Conduct GMP, QSR, Part 11 Electronic Systems, GLP and GCP Training Seminars

FDA.COM – Compliance consultation for current industry news and issues:

  • Senior Editor – GXP News – What’s new with CDER, CBER and CDRH – Weekly CFR Rule Changes for Title 21 Code of Federal Regulations
  • GXP Recruiters – Free recruiting web based job posting and recruiting board
  • GXP Conferences – Free conference site posting
  • GMP, GLP, ICH & GCP discussion group moderator
  • Validation (Process, Facility & Equipment) discussion group moderator
  • 21 CFR Part 11 Remediation & Computer Systems and Software Validation group moderator
  • Engineering, Technical and Strategic Issues discussion group moderator
  • NDA, ANDA, IND, PMA and 510k submissions discussion group moderator
  • Good Auditing Practice discussion group moderator
  • Site Compliance Issues – Biotechnology, Pharmaceutical, Medical Device, Food & Cosmetics

GMP Publications, Inc. – CEO - Senior Editor, Director Quality Assurance – Technical Writing

  • Technical development of the Code of Federal Regulations publications for The Government Printing Office, Washington, DC.
  • Quality Assurance Duties – Change Control, SOP development, Content Validation, Custom publication development
  • Support the Government Printing Office (GPO).  Conduct annual review, proofing of new regulations pertaining to 21 Code of Federal Regulations.  Conduct Quality Assurance assistance in ensuring that new regulations are free of text defects, and that content meets conformity and clarity. Title 21 Code of Federal Regulations Parts 1 - End.
  • In charge of the distribution of over 5mm+ copies of the Code of Federal Regulations / ICH Mini-Regulation handbooks to over 8,100 companies worldwide.

GXP Conferences, Inc. – Senior Instructor - http://www.gxpconferences.com

  • Conducted over 120 instructional webinars
  • Training and Development – Customized training packages and presentations:
    • 21 CFR Parts 210/211 Drug GMPs - The basics 101
    • 21 CFR Parts 210/211 Drug GMPs - The basics 102
    • 21 CFR Parts 11 – Electronic Records; Electronic Signatures
    • 21 CFR Parts 820 – Quality Systems Regulations
    • 21 CFR Part 58 – Good Laboratory Practice – Toxicology & Non-Toxicology
    • Pharmaceuticals – Finished and APIs
    • Software and Systems Development Compliance Requirements under 21 CFR Part 11
    • Validation and Qualification - The Basics 101
    • Validation and Qualification - The Basics 102

1999 to February 2003: SCIREX Clinical Research Organization (CRO)
Title:    Senior Instructor, Auditor, Associate Director Quality Assurance / Regulatory Affairs – GMP, GLP, Part 11 Electronic Records; Electronic Signatures, 820 Quality Systems Regulations and Clinical Training
Duties: Global 21 CFR Part 11 Initiative Developments and Remediation.  Developed, Implemented and Directed the SCIREX Global 21 CFR Part 11 Remediation Initiative for 9 US sites and 7 EU sites on a global scale.  Included but not limited to:

  • Develop, Implement, Manage and Conducted SCIREX Internal, Sponsor, Supplier and Vendor audits pertaining to IT, Validation, GMP, GLP, ICH, 21 CFR Part 11 and Facility Compliance.  Conducted internal personnel, Sponsors, and Vendor training in Good Auditing Practices,  21 CFR Part 11, Good Validation Practice and Techniques, Quality Systems Regulations (Part 820), Good Programming Standards and Practices, etc…
  • Senior Auditing Responsibilities – Development Audit Standards for;
    • Auditing Sponsors
    • Auditing Sponsor’s Vendors and Suppliers
    • FDA Assisted Audits, Do-Diligence, For-Cause, and Clinical Trial Approval Audits
    • Acting as 3rd. party auditors for Sponsor Contracts
    • Acting as 3rd. party auditors for FDA Assisted Audits
  • Development, training and execution of the Corporate Validation Standards and Policies
  • Development, training and management of the Corporate Validation Steering Committee
  • Implementation of the Corporate Computer Systems Validation Guidelines for multiple sites
  • Developed the Steering Committee 21 CFR Part 11 Charter, Validation Master and Project Plans
  • Coordinated the Validation efforts utilizing in-house technicians and Contractors
  • Developed the Global Computer Systems and Application Inventories
  • Published SOPs outlining Validation activities, SDLC process and individual tasks
  • Based on the verified inventory, implemented the Gap Analysis process which determined the components of the inventory items and requirements.
  • Based on the verified inventory, implemented the risk analysis and assessment process, which determined the level of validation, qualification or verification required.
  • Developed the project timelines (based on risk assessments and needs), using various validated or qualified tools such as MS Project Gantts, databases and 3rd. party software, i.e. Trackwise, Software Magic, Track-it and others.
  • Developed individual Software Systems and Application validation  protocols (see HUhttp://www.validations.comUH for additional validation effort details)
  • Implemented IT, development and service support SOPs
  • Developed Maintenance, IT Support and Systems or Application retirement plans
  • GMP, GLP, ICH & GCP Auditing

1994 – 1999 Sentry Technologies, Inc.
Title:     CEO Senior Developer / Senior Consultant / Auditor / Instructor (GMP – GCP – GLP – Systems) –

  • Sentry 2000 Pharmaceutical Compliance Software System
  • Sentry 2000 Calibration Management System
  • Sentry 2000 Work Order Management System
  • OEM 2000 Equipment Managmenet Software for Vendors and Suppliers
  • Bio-Pharm 2000 Software for Inventory Management - CMOs

Management of over 600 installations world-wide.
Technical Services Auditor / Engineer – Asset Auditor, Validation, Engineering, Application & Development Contract Engineering Services – Development, Systems Implementation and Validation Projects.  Technical services and support consultant for Merck, Novartis, SKB, Delavau, Colorcon, Bayer, Sterling Pharmaceuticals, GMP Institute, BioPharm, Johnson & Johnson, McNeil Consumer, The Validation Group, Judge, Integrated Project Services, etc…

  • Development, implement and validation of Maintenance, Material Management, SCADA, DCS, PLC, Compliance and Engineering software applications and systems
    • Validation Master Plan Development
    • Project Plan Development - User requirements - Functional requirements
    • Design qualifications (DQ)
    • Installation qualifications (IQ)
    • Operational qualifications (OQ)
    • Performance qualifications (PQ)
  • Auditing Services for Asset and Compliance Management
  • Development and Validation of Inventory Systems for Asset Control Systems
  • Engineering, Design/Build, Maintenance and Technical CAD Services
  • Turn-key Process, Equipment and Software Validation Services
  • Laboratory Design / Build Project Management
  • Laboratory Equipment Validation:
    • HVAC, Fume Hoods, Bio-Cabinets, Glove boxes, Class 100 – 100k, etc..
    • Process, Manufacturing and Laboratory Equipment
    • HPLCs, GCs, AA, Spectrophotometers, etc..
    • Software – System Gold, Pinnacle Millennium, Agilent/HPChemStation, etc..
    • Gases, Mobile Phase Pumping, AutoSamplers/AutoEnjectors,
    • Detectors, FTIR, UV Vis, Diode Array, Gas Flame, MassSpec, NMR, etc..
    • Asset Inventories and Gap Analysis

1989 – 1995: Sterling Pharmaceuticals  -  Bayer Pharmaceuticals – Integrated Project Services (IPS)
Title:     Manager of Engineering, Auditing and Technical Services contracted to Sterling Pharmaceuticals
Duties:  Direct, Audit, Maintained and Design/build responsibilities for Sterling Pharmaceuticals NJ R&D, & PA Manufacturing Facility.  Managed in-house and contract technical staff.  Developed SOPs, Validation Protocols and Project Plans.  Maintained Process, Utilities and Facility Equipment.  Development of Equipment specifications, Purchasing, and Validation of all Facility, Utility & Process Equipment and Systems:

  • Computer Systems, SCADA, DCS and PLC, validation protocols including VMP, IQ, and OQ
  • Network and Desktop Validation Protocols including VMP, IQ, and OQ
  • Analytical Equipment, Spectrophotometers, Samplers/Injectors, Pumps, Assay Equipment, etc.
  • Fluid Bed, Tray and Static Dryers, Mixers, Blenders & Sifters/Screeners
  • Steam Systems, Process & Utility, Water Systems, Process & Utility Washers, Sterilizers, Autoclaves
  • Electrical Systems and Power Generating Equipment
  • Tablet Manufacturing Equipment – Presses, Coaters, Sorters, Counters, Fillers & Gel Equipment
  • Environmental Equipment – HVAC, Environmental Chambers, Stability Chambers and Freezers
  • Packaging Equipment, Lab Equipment, Manufacturing Equipment
  • Development of Corporate Validation Standards for Process, Packaging, and Facility Equipment, Systems and Applications.
  • Clean-in-Place, Sterilize-In-Place, and Clean Room Process Cleaning validation. 
  • Developed Corporate standards (Eastman Kodak, Sanofi and Sterling Pharmaceuticals) for OSHA 1910.143, EPA Response, HAZMAT First Responder, Inventory Controls, and Engineering

1985 – 1989: Purolite
Title:     Maintenance and Engineering Director / Manager US
            Technical Consultant – UK
Duties:  Chief Engineer – Senior ISO Auditor - Construction and Maintenance.
            Development of ISO preparation documentation, services and procedures.
            Development of Quality Assurance initiatives in support of ISO Certifications.

  • Managed 18+ Technical Service Personnel, 3 Engineers and 200+ Trades.
  • Design / Build & CAD Engineering
  • Process Development
  • Pipefitting, Millwright, Welding, Electrical/Electronics, Steam and Water Systems, PLC, DCS, SCADA

Education

  • Burlington County College  - Mechanical Engineering – Computer Sciences – AutoCad release 11/2000 (Non-degreed)
  • Burlington County College – Computer Sciences - Computer Programming/Visual Basic programming (Non-degreed)
  • Drexel University, PA. – Architectural Design (Non Matriculated)
  • Great lakes Institute of Technology – BS – Propulsion Engineering, US Navy Propulsion engineering and steam generation plants. Damage control, Firefighting and HAZMAT training.
  • ISO Reg. Training, Purolite, PA
  • Good Manufacturing Practice – full training package (North East Branch Rep for GMP Institute)
  • DIA Good Clinical Practices – GCP
  • PDA Auditor – Tri-Auditors
  • ASQ – Certified Quality Auditing 2002
  • ASQ – Certified Quality Engineering 2002
  • Various training seminars, GMPs, Part 11, Clinical, Auditing, GLPs, ISO, etc…
  • Pipefitters Apprenticeship Program 8 month apprenticeship training program.
  • Star Technical Institute Electronics and Robotics – 18 month program.
  • Lyons Technical Institute AC&R – 10 month program
  • Stationary Engineering NJ Blue Seal, PA Engineers ‘A’ Licenses
  • Welder Training and Testing Institute – 10 month program
  • Woodward Clyde Environmental EPA 165 40 hour EPA certified HAZMAT First Responder Course
  • Borland Team B Specialist Training

Licenses, Certificates, Publications and Achievements

  • Web site author of GMP Publications, Inc. http://www.gmppublications.com
  • Web site author The Auditing Group, Inc. & Validations.com
  • Web site author of FDA.COM and Managing Editor / Discussions Coordinator http://www.fda.com
  • Managing Editor – GXPNews
  • Managing Editor and Quality Assurance for Government Printing Office – GMP Publications.
    • Proof reading of new regulations pertaining to 21 Code of Federal Regulations
    • Supporting the GPO in corrections and updating of the Code of Federal Regulations pertaining to 21 Code of Federal Regulations
  • Authored the Computer Systems Validation Guideline for Industry, published 8/2000
  • Authored the SENTRY 2000 cGMP Facility Management Software – 1800-682-0860
  • Authored the OEM Management System for Windows
  • GMP Training – GLP Training
  • GMP Train the Trainer – GMP Institute
  • GERM, Tri-Auditor Course, LIMS Management
  • Conducted numerous training seminars and conferences on GMPs, Mutual Global Harmonization and 21 CFR Part 11 Implementation and Site Remediation
  • Member of the GPO Review Board
  • ISPE Active Member and Management of the ISPE Delaware Valley Chapter Web site 1998-2000
  • DIA Active Member
  • PDA Active Member
  • ASQ Active Member
  • RAPs Active Member
  • AASP Active Member
  • Borland Developers Licensing partnership group
  • Microsoft Level 2 and Sun Developers Group
  • cGMP, FDA and OSHA compliance audit seminars
  • Written and conducted in-house fire, OSHA safety training and HAZMAT clean-up response training procedures
  • NJ EPA Certified 165.15 & 29 CFR 1910.120 Hazardous Waste Operations and Emergency Response
  • Written and conducted Confined Space Entry and Safety Tag & Lock out seminars, procedures and SOPs
  • Wrote the Eastman Kodak/Sterling Winthrop Safety Lockout Corporate Manual
  • Certified Yale fork truck training instructor
  • Red Cross First aid training
  • NJ State Blue Seal Engineering and Pa. Engineering A license
  • NJ State Blue Seal and Pa. Engineering ‘A’ Steam Boiler operations instructor.

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Partial Audit List

·    Institute for Clinical Research (ICRI) India

·    Propharma (Spain)

·    Nuvo Research (Canada)

·    Yamanouchi / Novel Pharmaceuticals – Japan

·    Ethicon Pharmaceuticals

·    IVAX – Ft. Lauderdale, FL

·    Roemmers – Argentina –

·    IDBiomedical

·    Organichem

·    Lavipharm Corporation

·    Computer Science Corporation (Validation Dept)

·    Xerimis

·    Introgen Therapeutics, Houston, TX

·    Amgen

·    DZS Clinical

·    Delavau Contract Manufacturer

·    Scirex – 6 Facility CRO Sites

·    Elan Pharmaceuticals – South San Francisco

·    Biovale – Desk Audit

·    PHT Corporation, MA

·    McNeil Pharmaceuticals, PA

·    SmithKline – PA

·    MDS – Canada – Desk Audit

·    Diamethane (Canada)

·    Oracle Clinical (Desk Audit)

·    SCIREX – Multiple EDC Company Audits

·    Pharma Recruiters, LLC (CV Reviews)

·    Covance – WI (GLP – GMP)

·    Advanced Molecular Sciences

·    Metastorm International

·    GMP Publications – Compliance Audits

·    ClinAudits – Multiple Company Audits

o       Labcorp Multiple Facilities - US

o       Covance – UK

o       Catalent - US

o       Esoterix – UK

·    Aardex Pharma – Switzerland

·    Clinilabs

·    Phaseforward eDC

·    Merck (NJ & PA)

·    Novartis – East Hanover, NJ

·    Poen Laboratories – Argentina –

·    Boehringer Ingelheim – Desk Audit

·    Luitpole – Multiple Audits

o       Datatrak

o       eTrials

o       eDM (eResearch Technology)

o       PDS (Phoenix Data Systems

·    Dispense Express, CA

·    Advanced Molecular

·    Ardex Hexalog Sion Switzerland

·    Darwin Partners (Sr. Auditor Consultant)

·    Radpharm, NJ

·    ADM, San Francisco

·    OmniComm Clinical

·    Liposome

·    World Care (CT)

·    Preimeir Clinical Research

·    BioImaging

·    Krunos Clinical

·    Beardsworth Clinical

·    PPD – Desk Part 11

·    Biomedical Corporation

·    Medifacts International

·    Imclone – Training Services

·    Bayer Pharma (Sterling Pharma) – PA – NJ

·    American Capital – Labstat

·    IntellegentMD

·    GMP Publications (Federal Regulations)

·    Clintrial (Desk Audit)

·    BluPharma – Decca Pharmaceuticals

·    GXP Recruiters, LLC (CV Reviews)

·    PPD – Austin, TX

·    Interphase systems – Multiple Company Audits – Systems - Validation

·    Jeiven Associates – Multiple Company

o       Corgenix

o       Merlin Labs

o       Micro Detect

 
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