US FDA Subject Matter Expert (SME)
Supporting CDER, CBER, CDRH, CFSAN and CVM along with EMA, TGA, WHO, and ISO Compliance Requirements.
Sr. Auditor, Instructor, Remediation Consultant
John currently manages and oversees the Audit, Editing and Validation operations at GMP Publications, Inc. (www.gmppublications.com), COO of The Auditing Group, Inc. (www.auditing.com) and CEO of GMP Boot Camps (www.gmpbootcamps.com).
Technical SME review of the Federal Regulations, CFRs supporting Title 21 Food and Drug Industry. John also manages the FDA.COM website (www.fda.com).
John has conducted 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.
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.
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:
- cGMP - Good Manufacturing Practice requirements supporting Bio-Pharmaceutical Industry
- Drug Manufacturing - API, Control Sustance, Biologics
- Medical Device - Class I, II, and III - Combination Devices
- GLP - Good Laboratory Practice requirements supporting laboratory and testing services
- GCP - Good Clinical Practice requirements supporting clinical activities
- Good Manufacturing Practice requirements for Food and Dietary Supplements - 21 CFR Part 111 Compliance
- ‘For-Cause’ and ‘Due-Diligence’ Audits and Gap Analysis. FDA EIR 483 Remediation
- Quality Management Systems Audits - Medical Device Industry (FDA / EMeA / ISO)
- Electronic Systems and Software Audits (21 CFR Part 11 / EU Annex 11)
- Validation and Qualification Audits, Gap Analysis and Development/Remediation
- Remediation Consultant – Audit remediation and project management
- Lead QA Review – Title 21 Code of Federal Regulations – GMP Publications/US FDA
Assists firms to meet compliance requirements by implementation of standards through:
- Development of Remediation and Resolution Plans
- Development of Validation Protocols for Software and Systems
- Conduct Audit, Gap Analysis and Risk Assessments for existing systems and software
- Compliance Auditor / Instructor – Regulated Industry Compliance Audits
- Conducting Vendor, Supplier, Contractor, Consultant, GXP Audits. Systems in support of GXP Activities
- Corporate VC, Mergers and Acquisitions, Risk Assessments and Gap Analysis
- Computer Systems, 21 CFR Part 11 ERES, IT, MIS Services, EDC, Clinical Systems and Data Capture ASPs, ISPs, SaaS, IaaS, IEEE Standards. EU EMeA Annex 11 – 15. Computer System Validation, Engineering, Development & Protocol Execution Audits. Validation and Qualification – GAMP 4/5
- Mock FDA, WHO, EMeA Audits and Pre-Audit Inspection Preparations
- GMP Audit and Gap Analysis - Medical Device – Part 820 Quality Systems Regulations. Quality Management Systems / Quality Assurance, Part 820 QSR, QSIT, ISO 13485, ISO 14971, ISO 14644
- GMP Audit and Gap Analysis - Parts 210/211 Drug GMPs/API (ICH Q7,8,9,10) Manufacturing. GMP Good Manufacturing Practice Audits. Parts 110 and 111 Food and Dietary Supplement GMPs
- GMP Audit and Gap Analysis - GLP Good Laboratory Practice Audits, 21 CFR Part 58, CLIA, OECD, Engineering, Facility & Validation, ISO 17025, Canadian 1510e Standard
- GMP Audit and Gap Analysis - GCP Good Clinical Practice Audits (Clinical Process & Systems in accordance with 21 CFR Parts 50, 54, 56, 312, & 314, & 511) Investigator, Site Monitoring, Pharmacovigilance, IND, AND, ANDA, BLA, PMA & 510k. ICH E6 – ICH Audits (E2A/B)
4 Linda Lane, Suite B, Southampton, NJ 08088 Tel: 609-217-7031