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Remediation Services...

30 years of assisting firms in meeting and exceeding quality compliance requierments. Extensive experience within the FDA regulated industries working under the various standards (cGMP, cGCP, cGLP, Systems) with one goal, to provide reliable Auditing, Remediation, Validation, Consulting, Training, and Quality Assurance services that efficiently provide the assistance needed to help our clients succeed.

  • For Cause
  • Due-Diligence

Assistance with;

CAPA Management
Project Management, Gantt and Timeline Management
Site Qualification and Facility Validation Expertise
Standard OperatingProcedure Development and Challenges
Validation Development and Executions
Training Services (GMP, GLP, GCP, Systems and Valdiation)
Development Part 11 Initiatives
Design / Build Engineering Services
'As-Built' Drafting Qualifications
Process and Equipment Validation Services
Software and Systems Validation Services

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:

  • Good Manufacturing Practice requirements supporting Bio-Pharmaceutical Industry
  • Good Laboratory Practice requirements supporting laboratory and testing services
  • Good Clinical Practice requirements supporting clinical activities
  • Good Manufacturing Practice requirements for Food and Dietary Supplements
  • ‘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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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