Compliance Made Simple
As an independent consultant, I will bring my substantiated know-how and expertise in a pragmatic and goal-oriented way into your business. My services comprise – tailored to your requirements and needs – the concept, integration, implementation and training, as well as control/audit and optimization of your:
This includes, of course, an individual adaptation to your internal strategies and standards as well as compliance with current legal and regulatory requirements and guidelines of EMA, FDA, ICH, ISPE GAMP etc., applying pro-active and risk based methods.
My assignments are always limited in time and prevail to the knowledge transfer and the sustainable success of your business.
BSI lead auditor for ISO 9001:2015 systems.
More than twenty years of professional experience, eleven of which within quality management of partially highly regulated fields of pharma and biotech. Sound knowledge of ISO 9001; ISO 13485; ICH Q9, ICH Q10; 21 CFR Part 11, ISPE GAMP5, ITSM.
Initiative, efficient and systematic work methodology and rapid adaptability to change, distinctive solution-driven analytical and systemic way of thinking. Flexible and confident implementation of coaching and training-techniques, strong network connections.