John F. Cuspilich, Sr. Auditor - Regulatory Affairs / Quality Assurance
Mailing Address: P.O. Box 1696, Medford, NJ 08055   Physical Address: 675 Stokes Road, Medford, NJ 08055   Tel: 856-596-2333   Fax: 609-654-5992

Areas of Expertise:

• Regulated Industry Compliance Audits –
  • Vendor, Supplier, Contractor, Consultant, Audits.  GMP – API – GLP – GCP – ISO – ICH
  • Computer Systems, Part 11 ERES, IT, MIS Services, Site Remediation, ‘For-Cause’, (E2B)
  • Quality Assurance, Part 820 QSR, QSIT, ISO 14971, ICH 13485, ISO 9xxx
  • GMP Good Manufacturing Practice Audits (21 CFR Part 210/211, ISO, ICH Q7A)
  • GLP Good Laboratory Practice Audits, CLIA, OECD, Engineering, Facility & Validation, Basic
  • 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)
• 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:
  • 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

 Work History:

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

Note:    FDA.COM & GMP Publications, Inc. since 1999.  Full time since Feb. 2002

 The Auditing Group, Inc.  (See attached Addendum A - Audit List)

 (Division of GMP Publications, Inc. & Pharm Recruiters, llc.)

Title:     Senior Consultant / Auditor / Associate, Associate Director Quality Assurance, Technical Compliance

Duties: The Auditing Group, Inc. & Validations.com - Compliance Auditor and Consultant:

·         GMP, GLP, ICH & GCP Auditing Services (Over 200 compliance audits since 2001)

o        Manufacturing, Research & Development, Clinical, Medical, Laboratories

o        Contract Manufacturer’s, Vendors & Suppliers

o        Bio-Pharma OTC, Ethical, Nutraceuticals, Chemical, Bulk API

·         Validation (Process, Facility & Equipment) Auditing Services

o        EDC, MRP, MMCS, LIMS, SCADA, PLC, DCS, Custom and COTS applications

o        Process Equipment, Manufacturing, Utilities, Engineering

·         Auditing and development of validation master plans for Computer Systems and Software including but not limited to:

o        SDLC, VMP, VPD development, user requirements and functional requirements

o        Design qualifications, including schemas, flow diagrams and data modeling

o        Installation qualifications, gap analysis, and component inventories

o        Operational qualifications, test script development, training and executions

o        Performance qualifications

·         Auditor of 21 CFR Part 11 Remediation & Computer Systems Validation

·         Audits of 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 Do-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

Duties: FDA.COM - Compliance consultation concerning industry issues:

·         GMP, GLP, ICH & GCP

·         Validation (Process, Facility & Equipment)

·         21 CFR Part 11 Remediation & Computer Systems and Software Validation

·         Engineering, Technical and Strategic Issues

·         NDA, ANDA, IND, PMA and 510k submissions

·         Good Auditing Practice

·         Site Compliance Issues – Biotechnology, Pharmaceutical, Medical Device, Food & Cosmetics

Duties: GMP Publications, Inc. – Senior Editor, Director Quality Assurance – Technical Writing & Review

• 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.
• In charge of the distribution of over 1,500,000 copies of the 21 Code of Federal Regulations / ICH Mini-Regulation handbooks to over 2,100 companies worldwide.

August 2000 to February 2002: SCIREX Clinical Research Organization

Title:    Senior Auditor, Associate Director Quality Assurance / Regulatory Affairs – GMP, GLP, Part 11 Electronic Records; Electronic Signatures, 820 Quality Systems Regulations and Clinical Training Services

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 3^rd. party auditors for Sponsor Contracts
  • Acting as 3^rd. 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 http://www.validations.com 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

Contact:            Mike Choukus – CEO, Jim Cotton – Director R/A, Pat Tenthorey – Director Q/A

January 1999 to August 2000: JWS Delavau

Title:     GMP / 21 CFR Part 11 Site Auditor, Technical Services Manager

Duties:  cGMP Technical and Engineering Controls Facilitator and Technical Services Manager. Project Manager. Prepare Facility audit reports, analysis and critical path actions lists. Coordinate cGMP policies, procedures and practices with Q/A - Q/C, Engineering, Validation and Operations. Green site facilitator following cGMPs

Development, Implement and Audit of Corporate Validation Standards for Process, Packaging, and Facility Equipment, Systems and Applications.

• Site Audit against cGMPs, GLPs, Engineering and Validation Standards.
• Design and Install various manufacturing systems; Process Equipment, Tablet Presses, Horizontal Continuous Dryers, Tablet Coaters, Packaging Equipment, etc...
• Clean-in-Place, Sterilize-In-Place, and Clean Room Process cleaning validation.
• Total design / build responsibility for Facility, and Equipment: HVAC – Class 1,000 – 100,000, Electrical Systems (Primary and Backup), Mechanicals, Plumbing, Gas, Laboratory, Utilities.
• Validation of Computer Systems and Software Applications, SCADA, PLC and DCS.

Contact – Steve Bailey, Director Technical Services

 1994 – 1999 Sentry Technologies, Inc.

Title:     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
  • User requirements
  • Functional requirements
  • Design qualifications
  • Installation qualifications
  • Operational qualifications
  • Performance qualifications
• 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 and Technical Services contracted to Sterling Pharmaceuticals

Duties:  Direct, 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 and Utility
• Electrical Systems and Power Generating Equipment
• Tablet Manufacturing Equipment – Presses, Coaters, Sorters, Counters, Fillers & Gel Equipment
• Washers, Sterilizers, Autoclaves
• 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 for Construction and Maintenance of 18mm Ion Exchange Manufacturer.

            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, Millwriting, Welding, Electrical, Electronics, Steam and Water Systems, PLC, DCS, SCADA etc..

 Education

• Burlington County College  - Mechanical Engineering degree with 42 Credits towards Computer Sciences degree – AutoCad release 11/2000 , ObjectPal Computer Programming Specialist C++ and Visual Basic programming
• Burlington County College – 42 Credits – Computer Sciences
• Drexel University, PA. – 24 Credits – Architectural Design
• 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
• Great lakes Institute of Technology – BS - Propulsion Engineering, US Navy Propulsion engineering and steam generation plants. Damage control, Firefighting and HAZMAT 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
• Conducted numerous training seminars and conferences on GMPs, Mutrual Global Harmonization and 21 CFR Part 11
• 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
• 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 Procedure
• Certified Yale fork truck training instructor
• Red Cross First aid training
• NJ State Blue Seal Engineering and Pa. Engineering A license
• Taught NJ state Blue Seal and Pa. Engineering ‘A’ Steam Boiler operations courses.

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Partial Audit List (2004 / 2005)

E-Research Technologies, Bridgewater, NJ

Yamanouchi / Novel Pharmaceuticals - Japan

Biovale – Desk Audit

Elan Pharmaceuticals – South San Francisco

Ethicon Pharmaceuticals

Krunos Clinical

Beardsworth Clinical

PPD – Desk Part 11

Boehringer Ingelheim – Desk Audit

Scirex – Sr. Auditing Director

Luitpole

            Datatrak

            eTrials

Delavau Contract Manufacturer

IVAX – Ft. Lauderdale, FL

Roemmers – Argentina – US – Contract Manufacture / Packaging

Poen Laboratories – Argentina – Contract Manufacture / Packaging

IDBiomedical

Dispense Express, CA

Merck – Rarway, NJ – Laboratory – Manufacturing / Packaging

Merck – Westpoint – Laboratory – Manufacturing / Packaging

Advanced Molecular

Organichem

Novartis – East Hanover, NJ

Ardex Hexalog

Lavipharm Corporation

Darwin Partners (Sr. Auditor Consultant)

Computer Science Corporation (Validation Department)

Radpharm, NJ

Xerimis

ADM, San Francisco

Introgen Therapeutics, Houston, TX

Liposome

OmniComm Clinical

OmniCom World Care

World Care (CT)

Amgen

DZS Clinical

Biomedical Corporation

Medifacts International

PHT Corporation, MA

McNeil Pharmaceuticals, PA

SmithKline – PA

Bayer Pharma – Packaging – NJ

MDS – Canada – Desk Audit

Glatt Contract – Desk Audit

Vector Contract – Desk Audit