John Cuspilich

John Cuspilich, Sr. Editor, Auditor and Consultant for GMP Publications, The Auditing Group and GXP Conferences. John currently oversees book editing and validation operations at GMP Publications, Inc.(www.gmppublications.com) in Medford, NJ, and is the COO of The Auditing Group, Inc. (www.auditing.com). John also manages the FDA.COM website (www.fda.com), a business and consumer information web portal for the Bio-Pharmaceutical and Medical communities. John has conducted more than 1000 GxP audits, Gap Analysis and remediation projects world-wide, with over 30 years, hands-on technical and management level experience within the Pharmaceutical, Biotechnology, Medical Device, Petrochemical, Validation, and regulated industries. Conducted over a thousands of GxP audits, Gap Analysis and Remediation projects world-wide, with over 30 years, hands-on technical and management level experience within the Pharmaceutical, Biotechnology, Medical Device, Petrochemical, Validation, and regulated industries. Over the past 30 years, John has conducted hundreds of speaking engagements, seminars and bootcamp style training seminars world-wide. Published, cosponsored and audit reviews of thousands of technical and professional papers, journals and books for hundreds of Companies in the regulated industry. John has assisted hundreds of 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; FDA (CDER, CBER, CDRH, CVM, CFSAN), 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. You can download a copy of John's CV at http://www.johncuspilich.com