
Name
Claus-Jürgen Koch
Function
Senior Consultant;
Qualified Person
Dr Claus-Jürgen Koch
Experience since 2002
Qualifications
Experience so far
Qualified Person (German Pharmaceutical Legislation) für marketed products and IMPs; responsible person for narcotic drugs (German Narcotic Drugs Act); transdermal therapeutic systems; team lead; project lead; Quality Assurance; GMP-compliance, batch-record-review; CAPA- and deviation management; complaint mangement; management of Change Control procedures; investigations; training; risk management, Product Quality Reviews; customer audits and inspections of health authorities; supplier qualification (auditing); Head of Quality Control; quality control of starting materials, intermediates/bulk and finished dosage forms (incl. testing of packaging materials and microbiologic investigations); stability studies; validations