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
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Introduction:
(Standard
Excerpt)
John has enjoyed
over 24 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,
Manufacturing, Research, Engineering, Technical Mechanical Departments,
etc.., John has assisted many companies in meeting and exceeding
regulatory compliance, pertaining to for-cause or do-diligence
situations. John has assisted companies to achieve, resolve, remediate
and exceed regulated industry requirements, mandates, for-cause and
do-diligence priorities with the technique of promoting GxP standards
and practices through interactive hands-on training.
John has extensive
knowledge in industry standards; cGMP, GLP, ICH, OECD, GAMP, ISO, OECD,
OSHA, HACCP, HIPPA, ACCPdEPA and FDA
regulations and thorough knowledge in the process of implementation of
these standards. |
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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:
-
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
Manufacturers, 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 Sponsors 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
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.
<end>
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