John Cuspilich Email and Phone Number
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US FDA, EMA, WHO and NMPA Subject Matter Expert (SME) Sr. GXP Auditor, Instructor, Remediation Consultant.Pharmaceuticals, Medical Device, Dietary Supplements and Cosmetics.Supporting: CDER, CBER, CDRH, CFSAN and CVM along with EMA, TGA, WHO, NMPA and ISO Compliance Requirements. DEA, CDC, NIH SME - Bio Defense, Statistical Analysis SMEGMP - GLP - CGP - ISO - QMS - SME AuditingGMP Publications - The Auditing Group - GMP Boot CampsJohn currently manages and oversees the GXP Audit, SME Regulatory Affairs and Compliance operations for GMP Publications, Inc. (www.gmppublications.com);Senior Auditor, Compliance SME and Chief Operating Officer for The Auditing Group, Inc. (www.auditing.com);Senior Instructor and CEO of GMP Boot Camps (www.gmpbootcamps.com); andSenior Editor, GXPNews - FDA News and AnnouncementsConducted more than 1400 GxP Compliance Audits, Gap Analysis, Training and Remediation projects world-wide, with over 35 years, hands-on technical and management level experience within the Pharmaceutical, Biotechnology, Medical Device, Petrochemical, Validation, and regulated industries. With 25 years as a Contract SME supporting US FDA Centers, i.e. CDER, CBER, CDRH and CFSAN, including, CDC and DEA Operations.John has conducted hundreds of speaking engagements, seminars and bootcamp style training seminars world-wide and published, co-sponsored and audit reviews of thousands of technical and professional manuals, procedures, papers, journals and books for hundreds of Companies and Federal Agencies world-wide within the regulated industry.Professional experience: GMP Audit and Gap Analysis Development - Process, Equipment, Facilities, Systems & Software, and Validation. John has conducted GMP Audits, Gap Analysis and Remediation consulting projects in support of:GMP - requirements supporting Bio-Pharmaceutical Industry- Drug Manufacturing - Excipients, API, Control Substance, Biologics- Medical Device - Class I, II, and III - Combination DevicesGLP - Good Laboratory PracticeGCP - Good Clinical PracticeFood and Dietary Supplements GMPs - 21 CFR Part 111 Compliance‘For-Cause’ and ‘Due-Diligence’ Audits and Gap Analysis. FDA EIR 483 RemediationQuality Management Systems Audits - Medical Device Industry (FDA / EMeA / ISO)Electronic Systems/Software Audits (21 CFR Part 11 / EU Annex 11)Validation audits, Gap Analysis and Development/RemediationRemediation Consultant – Audit remediation and project managementLead QA Review – Title 21 Code of Federal Regulations – GMP Publications/US FDA
The Auditing Group
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CeoThe Auditing Group Jan 2002 - PresentMedford, Us• GMP, GLP, ICH & GCP Auditing Services - Manufacturing, Research & Development, Clinical, Medical, Laboratories - Contract Manufacturer’s, Vendors & Suppliers - Bio-Pharma OTC, Ethical, Nutraceuticals, Chemical, Bulk API - Mock FDA, WHO, and EMEA Audits• Validation (Process, Facility & Equipment) Auditing Services - EDC, MRP, MMCS, LIMS, SCADA, PLC, DCS, Custom and COTS applications - Process Equipment, Manufacturing, Utilities, Engineering• 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• 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
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Senior InstructorGmp Boot Camps And Gxp Conferences Jan 2011 - PresentOn-site and Webinar Instructor:- GMP QMS Training- 21 CFR Parts 210/211 Drug GMPs- Computer System Validation- 21 CFR Part 11 / EU Annex 11- 21 CFR Part 820 Medical Device Quality Systems Manual- Auditing GMPs The Basics Part 1 and Part 2- Good Laboratory Practice - Part 58 - OECD
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Senior PrincipalGmp Publications Fda.Com Jan 2000 - PresentGMP Publications http://www.gmppublications.comFDA.COM http://www.fda.comThe Auditing Group, Inc. http://www.auditing.com
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Associate Director QaScirex 1999 - 2002Us -
OwnerSentry Technologies, Inc. Jan 1994 - Dec 1999Houston, Texas, UsGMP Auditing and Asset Management Engineering Services. Development and Distribution of CMMS systems for the biopharma industry. GMP Training and Education Services with GMP Institute. Sentry 2000 Compliance Management Systems. Over 630 copies world-wide.Sold 1999. -
Validation Engineer - Audit Management Software Development ServicesThe Validation Group 1995 - 1996Full Validation Services supporting the Bio-Technology Industry. Development and Execution of Protocols for Process, Systems, Equipment and Facilities.
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Engineering & Technical ServicesSterling Health 1990 - 1995 -
Maintenance And Engineering SterlingIntergrated Project Services 1990 - 1995
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ContractorBayer Healthcare 1990 - 1995Leverkusen, North Rhine-Westphalia, De
John Cuspilich Skills
John Cuspilich Education Details
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Eastern Illinois UniversityPropulsion Engineering -
Drexel University College Of EngineeringMechanical Engineering
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Rowan College At Burlington CountyEngineering Design
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Star TechnicalElectronics And Robotics
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Lincoln TechAir Conditioning And Refrigeration Engineering Technology/Technician
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WttiWelding Technology/Welder
Frequently Asked Questions about John Cuspilich
What company does John Cuspilich work for?
John Cuspilich works for The Auditing Group
What is John Cuspilich's role at the current company?
John Cuspilich's current role is CEO - The Quality Groups, The Auditing Group, GMP Publications, & GMP Boot Camps.
What is John Cuspilich's email address?
John Cuspilich's email address is jc****@****fda.com
What is John Cuspilich's direct phone number?
John Cuspilich's direct phone number is +185681*****
What schools did John Cuspilich attend?
John Cuspilich attended Eastern Illinois University, Drexel University College Of Engineering, Rowan College At Burlington County, Star Technical, Lincoln Tech, Wtti.
What are some of John Cuspilich's interests?
John Cuspilich has interest in Gxp, Part 11, Gcp, Glp, Fda, Gmp.
What skills is John Cuspilich known for?
John Cuspilich has skills like Fda, Validation, Sop, 21 Cfr Part 11, Gmp, Regulatory Affairs, Quality Assurance, Quality System, U.s. Food And Drug Administration, Biopharmaceuticals, Standard Operating Procedure, Pharmaceutical Industry.
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