John is the CEO and Senior Auditor for The Auditing Group, Inc. (www.auditing.com).
John also serves as the Senior Editor at GMP Publications, Inc. and the CEO of The Validation Group.
John has conducted more than 1200 GxP audits, Gap Analysis 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.
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, remediation 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.