Seminars on Demand:

choose your seminar of interest and gain insider knowledge for relevant aspects in biotech management. Individual certificate acknowledges retraining in topic that may be requested in your new job in biotech industry.
Create your own biotech/pharma business profile and increase your unique feature for application and interview!

Seminar on demand

GMP Manufacturing

International Guidelines

4
Genre: Biomanufacturing
Length: 24 minutes
Keywords: GMP, GLP, Quality Management, US legislation, FDA, EMA

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 (EMA) 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.

Go back