About the Webinar
The approach presented is a 5-step checklist & systems development to a mature, robust Quality Management System. A mature QMS is not equivalent to having a QMS that has aged over the years. Assessment of the QMS and evaluating its level of maturity, compared against corporate expectations and evolving regulatory insights is done only in exceptional cases. Maturing the QMS gives a compliant, comprehensive, and robust repository, creates a consistent home for systems, procedures, and documents meeting regulatory requirements. Depending on the life cycle of the organization and the QMS, the pre-approval inspection may be the spark, the LEAN initiative the ongoing continuation, and the continuous inspection readiness the ultimate goal.
About Tobias Kuners
Tobias is an independent, self-employed consultant and Interim Manager and has been responsible for many different types of projects, including change management projects, turn around, maturing QMS systems, Supply Chain, and investments for Biotech, Cell & Gene, Radiopharmaceutical, and Medical Nutrition Facilities in Hungary, Germany, and the Netherlands. Leading in periods full of ambiguity, delivering key milestones on time, in full, while growing the team and building key competencies at the same time. Managing third-party EPCM suppliers & contractors. Working closely with local governments for environmental impact assessments, permits, and alignments with the immediate neighbourhood.
12 июл 2024
