References | QualityVision

Selected projects and assignments

Design control

Task
QA project manager development of medical device

QA MDR project

Task: QA-project resource in MDR implementation project Preparation and updating of documentation according to MDR and ISO 14971: 2019

Risk Management

Task:
Preparation of documentation for cleanroom facility
Risk Management by creating risk assessments (pFMEA)
URSs for Cleanroom, HVAC, compressed air & water treatment

cGMP training

Task:
In House Basic cGMP training for production and QC
EudraLex - Volume 4 - GMP Guidelines for Good Production Practices
Part IV - GMP requirements for advanced therapy medicinal products
Q9 Quality risk management
Annex 15 Qualification and validation

Project management

Task:
QA project manager in transfer project, injection molding machine, test methods and three products
Meeting planning
Creating risk assessments (PFMEA for process and software GXP assessments)
Validation master plan, validation plans, IQ, OQ, PQ and PV documents

References

"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."

Source:

"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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