Assisted start-ups and established companies in meeting and exceeding FDA & Global regulatory compliance, pertaining to ‘for-cause’ or ‘due-diligence’ remediation.  Assisting companies to achieve, resolve, remediate and exceed regulated requirements, mandates, with the technique of promoting GxP standards and practices through template development, and  interactive hands-on training. Global traveling  with 10year Chinese and India VISAs.

 

• CGMP  –  QMS  –  GCP  –  GLCP  –  GLP  –  GVP  –  21 CFR PART 11  –  QSR – ISO 13485 SME

• Execution of Turn-Key GMP and QMS processes, procedures, and infrastructure for start-ups and existing companies. Challenging Quality Management Systems for regulatory readiness.

• Gap Analysis of Existing QMS GMP Compliance Standards – New Standards Implementation

 

Extensive knowledge in industry regulations and standards; U.S. FDA (CDER (DEA), CBER, CDRH, CVM, CFSAN), CGMP, GLP, ICH, EU EMA GMPs & Directives, OECD, GAMP, ISO, NMPA (China), PMDA JPAL (Japan), OSHA, HHS, ACCPdEPA and GCP regulations and thorough knowledge in the process of implementation of these standards.

John enjoys speaking and engaging at many of the industry professional associations, seminars, and trade shows worldwide, conducting both on-site and off-site training seminars, and speaking engagements.”

 

Pharmaceutical, Medical Device, Clinical, Biologics, Dietary & Cosmetics Audits Gap Analysis:

Develop, challenge and execute audit plans for global on-site or remote Audits for Vendors/Suppliers, CMOs, CDMOs, CROs, for Manufacturing and Clinical Internal Departments. Development of Gap Analysis project plans to support the regulated industry,

• Pharmaceutical, APIs, Excipients, Controlled Substance, Biologics, Blood, Cell, Tissue, 503B

• Laboratories, and Analytical Services – Stabilities – GMP/GCP/GCLP

• Dietary Supplements – Retail Market Certifications

• Cosmetics – Therapeutic and nontherapeutic

 

Medical Device Quality Systems Regulations and Quality Management Systems. Assisting companies to meet U.S. CDRH requirements, ISO 13485 and E.U. 2017/745 Medical Device Regulations. Combination Devices for Pharmaceutical or Biologics. PMA / 510(k). Mock CDRH Audits and Gap Analysis (ISO 13485)

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Good Clinical Practice and Good Clinical Laboratory Practice Auditor, Trainer and Monitoring SME.

GCP Auditor – Quality Assurance Oversight, and Project Management. Investigational Products in accordance with CGMPs for Phase 1, Investigator Site Audits, Regulatory Affairs and Safety, Database and DM Audits, eDC Systems and Clinical Monitoring activities supporting Human and Veterinary Studies.

 

Engineering - Process, Equipment, Facilities, Systems & Software Qualification, Validation Expertise:

Extensive Process, Equipment, Systems, Device, Computer systems, and Software Validation and GXP Audit experience for the Regulated Industry. Work in support of Good Validation Practice Standards. 

 

Instructor / Trainer – GMP – GLP – GCP – ISO 13485 Training Program Director and Gap Analysis Auditor:

Conducted numerous conferences and seminars on Good Manufacturing Practice (GMPs), Quality Management Systems (QMS), Computer Systems Validation and 21 CFR Part 11 Compliance requirements.