Udvalgte projekter og opgaver
QA MDR-projekt
Opgave:
- QA-projektressource i MDR implementeringsprojekt
- Udarbejdelse og opdatering af dokumentation i henhold til MDR og ISO 14971:2019
Projekt
Kunde: Medical Device
Lokation: Danmark
Varighed: 4 mrd.
Grundlæggende cGMP træning
Opgave:
- In House Basis cGMP-træning til produktion og QC
- EudraLex - bind 4 - GMP-retningslinjer for god produktion praksis
- Part IV - GMP-krav til lægemidler til avanceret terapi
- Q9 Kvalitetsrisikostyring
- Annex 15 Kvalificering og validering
Projekt
Kunde: Farmaceutisk
Lokation: Danmark
Varighed: 1 dag
Risk Management
Opgave:
- Udarbejdelse af dokumentation til renrumsfacilitet
- Risk Management ved at oprette risikovurderinger (pFMEA)
- URS'er for Renrum, HVAC, trykluft & vandbehandling
Projekt
Kunde: Medical Device
Lokation: Danmark & Polen
Varighed: 3½ mrd.
QA-projektleder
Opgave:
- QA-projektleder i transfer-projekt, sprøjtestøbemaskine, testmetoder samt tre produkter
- Mødeplanlægning
- Oprettelse af risikovurderinger (pFMEA til proces- og software GXP-vurderinger)
- Valideringsmasterplan, valideringsplaner, IQ, OQ, PQ og PV dokumenter
Projekt
Kunde: Medical Device
Lokation: Danmark
Varighed: 6 mdr.
Udvalgte anbefalinger
"Tom is a highly respected and well liked consultant. His knowhow is absolutely indispensable and I would highly recommend his work to others."
"Tom was my main contact person in the framework of an international medical device transfer project. He impressed me not only with his comprehensive knowledge of standards and regulations, but also with their practical implementation. On top of his professional proficiency, he is a very kind and open person to work with, enriching personal interaction with a subtle sense of humor."
"Tom is mastering the noble art of communicating quality assurance and risk management in a way that make the listeners stay awake (!), be engaged and participate in discussions concerning these necessary, but basicallly unsexy topics. This is due to his deep knowledge of the subjects in combination with his personal qualities being a brave and humorous person."
"I've used Tom as a validation consultant in 3 different projects. The projects was to prepare Process-FMEA and validation documents. Tom is always provide a high standard of work and are not afraid to challenge you to do it smarter or faster. Tom is very familiar with the medical device regulations and can help you to follow it in the right way. As a person Tom is a very friendly person and fall easily into a project group."
Kilde:
"Structure, deals kept, rational is some o the keywords that i would describe him with. Him very pleasent to work with, with at specialist knowlegde to validation in pharmaceutical companies."
"Tom is highly skilled within the field of Quality Assurance and always work with a solution- and risk-based approach. He has a special ability to understand and adapt to the needs of whatever project, he is working on and hereby provide the most qualitative and often fastest/easiest/cheapest solution. Tom is a kind persona and with his subtle sense of humour, he is able to create a pleasant work environment in which learning, teamwork and professionalism thrives."
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