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
Listed skills include Fda, Validation, Sop, 21 Cfr Part 11, and 12 others.
