Process risk assessments, DQ and RTM based upon analysis of risk
On site tailored training courses in sterile product manufacture and specific technical support areas
Critical utilities: Risk assessment, biofilm control, sanitisation, qualification review and aged plant analysis
Project engineering support from URS to PQ good engineering practice (GEP) throughout the project
Some of the companies we have worked with
SME support to your processes for project work, troubleshooting and process improvement
Some of the companies we have worked with
High purity water systems from raw water to point of use and user point management
Sterilisation and depyrogenation processes, including EN285 requirements for porous load sterilisation
Philip Jarvis, Validation Manager, BioMarinGreat feedback from the validation guys who attended from BioMarin – Mark is a fountain of knowledge.
A N O Maintenance EngineerThe introduction to Microbiology has made sense of what I have been struggling with for years!
Stan O'Neill, Managing Director, The Compliance GroupWhenever a company had a problem, Mark was the person to provide the solution, rather than just a temporary patch.
Gary Hartnett, Bausch & LombMark is a very personable guy. He has a fantastic drive for results, is very customer focused, creative and leverages from a deep understanding of the pharma industry.
David McGovern, Business Transformation Projects Manager, GE HealthcareMark has an in depth working knowledge of regulatory standards and applies hist vast experience to offer robust technical solutions, training and guidance.
Nick Batty, Quality & Compliance Training Manager, Health Protection AgencyMark provides an excellent portfolio of training and consultancy around GMP, pharmaceutical engineering, sterilisation, compliance and water systems.
Danny Healy, VP QA, Trygg PharmaMark has led the provision of sterilization related external advice and contracted service
to our company in Cork, Ireland for over 10 years.
Murraigh McDonald, Autoclave & Fermentation Pure Culture Engineer, ElancoI have personally enjoyed and benefitted from several training sessions and the training courses always receive positive feedback from colleagues.
Leona Flynn, CQV Engineer, AlexionHis work was excellent and I would not hesitate to call upon his services again.
Chris Maughan, Managing Director, Thermal Compliance LtdHis ability to inspire confidence and his calm analytical approach to problem solving makes him a great member of any team.