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

Introduction: (Standard Excerpt)

“John has enjoyed over 26 years of hands-on technical and management level experience within the Pharmaceutical, Biotechnology, Medical Device, Petrochemical, Validation, and regulated industries world wide. 

Serving within various business units from 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(do)-diligence’ situations.  John has assisted 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; FDA, cGMP, GLP, ICH, OECD, GAMP, ISO, OECD, OSHA, HACCP, HIPPA, ACCPdEPA 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 world wide, conducted both on-site and off-site training seminars, and speaking engagements.”

 

Areas of Expertise:


 

History:

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. & GXP 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 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

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

 


 

1999 to February 2003: SCIREX Clinical Research Organization

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:

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


1994 – 1999 Sentry Technologies, Inc.

Title:     Senior Consultant / Auditor / Instructor (GMP – GCP – GLP – Systems) - 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…

 

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:

 

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.

 

Education

 

Licenses, Certificates, Publications and Achievements

 

 

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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

·    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)

·    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)

·    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