As the Managing Director of MTL Projects Ltd, I lead a team of engineers and consultants who provide CQV, training, and consultancy services to the life science industries, especially in sterile product manufacture. I have 35 years of experience in pharmaceutical engineering, working with global clients and regulatory bodies to deliver process improvement, compliance, and innovation.My mission is to support the development and production of safe and effective medicines and devices for patients around the world, using my expertise in Sterile Product Manufacture.Detailed SME guidance in Aseptic manufacture, Terminal Sterilisation, Sterilisation, Depyrogenation, critical utilities, and lyophilisation. I have also contributed to training of several regulatory inspectorates around the worlds, including in 2015 when the Chinese state FDA were adopting EU GMP's I delivered training courses, attended inspections and wrote an inspection guideline for Terminal Sterilisation for the then SFDA.Through WHO contacts I provided support to the Bill Gates foundation for establishing vaccine manufacturing facilities in countries/facilities outside EMA/FDA control. I am passionate about sharing my knowledge and best practices through publications, presentations, and training courses.