This seminar deals with current regulatory affairs in Good Manufacturing Practice directed
by US agency FDA. Relevant guidelines for compliance and documentation requirements
for development and production are illustrated.
Drug manufacturing represents cost-intensive proceeding which has to follow accurately
to international guidelines and directives. International authorities such as Food and
Drug Admistration (FDA) and European Medicines Agency (EMEA) are responsible
for approval of therapeutic agents. Good Manufacturing Practice (GMP) compliance of
manufacturers is obligatory for successfull approval.
Prospective project managers dealing with GMP compliance have to face enormous
documentation requirements in different areas of drug manufacturing. Their responsibilty
is focussed on setup of documentation structures for maintenance of quality and safety.
This seminar deals with current regulatory affairs in Good Manufacturing Practice directed
by US agency FDA. Relevant guidelines for compliance and documentation requirements
for development and production are illustrated.
