Thomas Makait

As Senior Management Consultant, Thomas Makait supports major pharmaceutical clients in the regulatory-compliant design, implementation and operation of MTP-based modular plants in green and brownfield environments. Typically, as Interim QA Manager Computerised Systems Validation, Thomas supports quality and technical compliance organisations in implementing and optimising equipment qualification and computerised systems validation approaches and procedures to exploit the benefits of the MTP-based modular plant concept in GxP-environments: • Reducing engineering effort by up to 70% by accelerating the development process and transition to industrial production; • Increasing expandability and reusability of modular units/equipment by up to 80%; • Reducing time to market and commissioning by up to 50%. The implementation of intrinsically compliant Modular Plant Lifecycle processes has become his professional focus in recent years. Based on the experience gained, Thomas initiated and leads the Global ISPE® GAMP® Special Interest Group for Qualification / Validation of MTP-based Modular Plants. Thomas is an automation engineer by education. During his more than 26 years in the pharmaceutical industry, he has held various management positions. In addition to many years in project management, project risk management, technical compliance and quality management, he is an active member of various professional organisations such as VDI, NAMUR and ISPE® GAMP® DACH and has contributed to several publications related to modular plants. After 10 years at Sanofi-Aventis as Technical Compliance Manager and Quality Assurance Manager for regulated computerised systems, Thomas has been running his consulting company QPRI & MTP4Pharma® - Intrinsic Plug & Produce Compliance since 2012.