A microbiologist by profession, Mr. Lush has considerable experience in the manufacture, quality assurance and testing of aseptic products. He is also qualified to act as a Qualified Person within the EU. He holds a master’s degree in medical microbiology, a BSc in medical science and a post-graduate diploma in quality management systems. He is also an honorary lecturer at the School of Pharmacy, University of Strathclyde, Scotland.
Mr. Lush has been involved in the design, qualification and operation of over 15 plants manufacturing sterile products. Passionate about continuous quality improvement in the pharmaceutical industry, he believes that most pharma companies are 20-30 years behind industries like automobiles and microelectronics. He is currently working with many companies to help them close this gap.
Mr. Lush is respected for his expertise in helping companies simplify and dramatically improve their quality systems by removing non value-adding operations and improving compliance at minimal cost. Other areas of expertise include:
- Crisis management: Helping companies survive severe regulatory action (consent decrees and warning letters)
- Quality systems: How to simplify and improve operational effectiveness
- Quality leadership: Helping you to get the best from your people
- Human error: Causes and prevention
- Error reduction and process improvement
- The design and implementation of efficient and simple change management systems
- Deviation and CAPA systems that drive continuous improvement
- Troubleshooting and problem solving to root cause
- Training and education effectiveness (as a qualified practitioner of accelerated learning teaching methods)
- Batch record review and product release procedures
- Performance measure development