Neil Lloyd

Neil Lloyd, CQV Consultant at Mayden Hayes Consulting Ltd has also worked as CQV Project Lead on multiple projects ranging from 50M to 1B $, for Drug Substance, Drug Product and API Facilities. He has more than 25 years of experience working in laboratory, manufacturing, design and CQV cGMP environments. The majority of his time has been spent in CQV teams, working hands on and in a lead capacity on start-up biopharmaceutical facilities. Extensive experience with sterile facilities, upstream & downstream processing equipment and systems, process support equipment and clean utility generation, storage and distribution systems. In the development of and implementation of CQV strategies for fast track projects compliant with the requirements of regulatory bodies and ensuring fitness for intended purpose. Being involved in projects from design stage to build in quality to the CQV lifecycle. Ensuring user requirements are SMART and QRA’s are focused on impact to the product and the patient. Neil has prepared VMP’s for projects with a science and risk based approach. Using different CQV strategies to achieve this, the traditional leveraged commissioning approach and ASTME2500. He has generated the underlying plans and procedures that support and control the CQV strategy, such as risk assessment procedures, change management and verification plans. Neil understands the pressures fast track projects put on the quality, efficiency and effectiveness of a CQV Project. And what practices need to be put in place to ensure compliance throughout.