“My goal is to support you with practical and realistic solutions for your day-to-day GxP challenges.”

Mark Nelissen
GxP Consultant
My Profile

My working style can best be described as rational and consensus-based. I look for room to maneuvre within the GxP (or client regulations) and make use of it in a sensible way, to come up with solutions. During more than twenty years I applied this style in several functional areas and developed the relevant competences. The areas and related competences are described below.

Area 1: Validation Management

  • Project Management
  • Setup Validation framework (Policies, SOP’s)
  • End-to-end validation management of computerized laboratory or production systems
  • Coordinate validation activities
  • Plan activities & resources
  • Partner with (project) Sponsor
  • Partner with management
  • Contact of external vendor/supplier

Area 2: Validation Engineering

  • Create Validation Plans
  • Setup (Requirements) Specifications
  • Create Installation Qualification Testing Plans & Reports
  • Draw up Operational Qualification Testing Plans & Reports
  • Performance Qualification Testing Plans & reports
  • User Acceptance Testing Plans & Reports
  • Compose System Standard Operating Procedures
  • Validation Summary Report

Area 3: Asset Management

  • Monitor and maintain Controlled State of validated systems
  • Periodic Reviews
  • Change Management
  • Deviation Management
  • CAPA handling
  • Compose Standard Operating Procedures & Working Instructions
  • Coordinate Maintenance & Repair activities
  • Maintain Life Cycle Documentation
  • Execute Root Cause Analysis
  • Partner with Quality Department

Area 4: Quality Assurance

  • Setup Validation Framework
  • Review Validation Documentation
  • Approve Validation Documentation
  • Support Root Cause Analysis
  • Review and Approve Changes, Deviations
  • Progress monitoring of Changes, Deviations and CAPA’s

More about me…

  • Working experience: > 20 years
  • Regulation experience: GMP, GLP, FDA 21 CFR 11
  • Guideline experience: GAMP, OECD
  • Project Management (Prince 2)
  • Areas of expertise: Computerized Lab Systems, Stand-Alone Laboratory instruments, production systems (sterile- and non-sterile)
  • Career: Organon, Schering-Plough, Banner PharmaCaps (Patheon Softgels) MSD, PharmaCell (Lonza), Rescop B.V.

Nelissen GxP Consultancy

Boekweithof 79    ·    5351 MG Berghem    ·    Tel 06-16457177    ·    e-mail m.nelissen@nelissengxpconsultancy.nl

www.nelissengxpconsultancy.nl    ·    Bank NL12 INGB 0009 3181 09    ·    BTW NL001765702B71   ·  KvK 75223384