Dr. Fritz Erni has a Ph.D. from the Swiss Federal Institute of Technology (Dr. sc.nat. ETH)
in Zurich and more than 30 years experience in research, development and quality
assurance in the pharmaceutical industry. He started his career in Japan in research at
Hitachi Ltd. and moved 1974 to Sandoz in Basel to take up a position in Analytical
Research and Development. He had several positions in the analytical research and
development of new drug substances and products and was promoted to Head of
Analytical Research and Development in 1986. In 1995 he moved to Technical
Operations, where he had several management positions in Quality Assurance/Control
at Sandoz and later after the merger within Novartis. From 2000 to 2002 he was
Director of Novartis Pharmanalytica SA in Locarno, Switzerland, a company specialized
in stability testing for the Novartis group. Since November 2002 he was head of
Technical Liaison, Global Quality Operations of Novartis in Basel. In this function he was
also responsible for the establishing of Novartis Global activities on Process Analytical
Technologies (PAT) and Quality by Design. Dr. Erni was also teaching Analytical Chemistry
for advanced students in Chemistry at the Swiss Federal Institute of Technology in Zurich.
He has published more than 50 papers.
Since 1992 he is topic leader of the European Industry (EFPIA) for impurity topics for the
International Conference on Harmonization (ICH) and was involved in the elaboration of
the impurity ICH guidelines for impurities in drug substances, impurity in drug products and
residual solvents. He was also member of the ICH Expert Working Group Q8 on Pharmaceu-
tical Development and the ICH Q8/Q9/Q10 Implementation Working Group.
Since 2009 he retired from Novartis after 35 years in the pharmaceutical Industry and is
working as a consultant on modern concepts for CMC submissions QRM and QbD.