Dr. Hans-Herwig Bauer has been working in pharmaceutical industry for over 15 years in different Quality leading positions, located in production sites for API and biotechnology products, solid and semi solid drug products and sterile liquid drug products. His experience includes inspections, especially FDA and other authorities all over the world. In addition he has great experience as trainer for lead auditors. In the past he has been responsible for introducing Quality Management systems and also for Lean Six Sigma projects related to Quality. At the moment he works as Quality director in Switzerland (Akorn Pharmaceuticals) for liquid sterile drug products responsible for all QA and QC- activities, including process validation group and Regulatory affairs.