Hermans - Ver Berne
+32 (16) 570658
Curriculum Vitae
Koen Hermans .
Nationality : Belgian
Date of birth : 12/05/1964
Native language : Dutch
Title : Senior System Architect
Contact person : Koen Hermans
Direct phone : +32-(0)495/545454
E-mail : koen@hcsd.be
Computer installation specialist subject to validation and 21CFR11
Languages
Language | Spoken | Written |
Dutch | Natve | Native |
English | Fluent | Fluent |
French | Fluent | Good |
German | Fluent | Basic |
Specialities
Koen is an expert in installation, maintenance and upgrading of industrial computers. Especially those computer systems that are GMP critical and need to be held in a controlled state.
He has co-designed a complete validation system to install computers in a controlled way. This includes solutions for security issues and audit trail of events and interventions. Recovery of malfunctioning computers and business continuity are also addressed in these validation documents.
He also works together and discusses with other suppliers to deliver their computer systems following the same validation approach, the same recovery and the same security rules. Using his knowledge in GAMP4, validation, 21CFR11 and experience with the FDA requirements is often put to work in projects for customers who need to keep their computer park under control.
The last development is running these controlled computers in a virtual world hosted on a VMWare ESX layer. New issues came along and were all tackled using the newest techniques in the computer sience.
Training
Training | Trainer / Company | Location |
Project / Computer Validation | Pfizer | Belgium |
BA4-5 | AIB Vincotte | Belgium |
Labview introduction | CIT | Belgium |
GAMP 4 | Pfizer | Belgium |
A1 System analysis | HRITO | Belgium |
Knowledge
Validation in pharmaceutical environments | Level |
Validation plan | Expert |
Requirements | Good |
Functional specifications | Good |
Design specifications | Good |
IQ Protocol/Report | Expert |
OQ Protocol/Report | Expert |
PQ Protocol/Report | Expert |
Computer validation | Expert |
CFR21 Part 11 | Expert |
GAMP 3, 4, 5 | Expert |
Remark | Multiple systems subject to 21CFR11 implemented or validated by Koen Hermans where audited by the FDA @ Pharmacia Belgium. Koen has discussed sterilization monitoring with the FDA auditors and all systems where found to be in compliance to FDA regulations by the auditors. |
Development / Languages | Level |
Delphi | Basic developer |
Foxpro | Basic developer |
VB.NET / VB | Regular developer |
C++ / Visual C | Developer |
Microsoft office automation | Experienced developer |
Remark | Koen has reviewed and maintained several automation projects. He has tested and stress tested different solutions from suppliers and worked together with them to improve their implementation of GMP critical applications. |
Operating systems | Level |
Windows - all flavors | Experienced administrator |
DOS | Expert |
Linux | Basic user |
Apple OS | Basic user |
Office | Level |
Word - Excel - Powerpoint - Project - Access - Visio | Experienced user |
Visualisation | Level |
CorelDraw | Experienced integrator |
Adobe Illustrator | Experienced user |
AutoCAD | Basic user |
Virtualisation | Level |
VMWare | Experienced user |
Citrix | Basic user |
Remote control (Timbuktu, VNC, netsupport ..) | Experienced user |
Professional experience