Bioforum - Applied Knowledge Center

Qualification

On SiteTraining

Quality	Developing a Quality System to Control Variation	Ms. Karen Ginsbury	A10358
	A Holistic Approach To CAPA (Corrective And Preventive Action) Using CAPA as a tool for quality management	Ms. Karen Ginsbury	A10359
	Technology Transfer – R&D to Production, Site Transfer and Outsourcing in the Pharmaceutical Industry	Dr. Malcolm Ross	A10226
Medical Device	Medical Device Clinical Studies & Clinical Evaluation for CE Marking	Dr. Monica Tocchi	A10049
	Sterilization by Ethylene Oxide	Mr. Daniel Floyd (Nelson’s Lab)	A10252
	Sterilization by Radiation	Mr. Martell Winters (Nelson’s Lab)	A10040
	Design Verification and Validation Methods	Mr. Clay Anselmo	A10357
Regulatory Affairs	Marketing Authorization of Biologicals in the EU What needs to be considered	Dr. Barbara Jentges	A10303
Manufacturing	Managing Extractables and Leachables in Pharmaceutical Products	Dr. Edward J. Smith	A10291
	Developing Clinical Quality Assurance Audit Skills and Procedures (CQA)	Mr. Steve Schwartz	A10014
Clinical Trials	Medical Device Clinical Studies & Clinical Evaluation for CE Marking	Dr. Monica Tocchi	A10049
Biotechnology	Development and Validation of Bioassays	Dr. Ana Menendez	A10134
	Fast Tracking Clinical Trials Materials to the EU Regulatory and quality aspects	Ms. Karen Ginsbury	A10360
A Bridge to the EU	Medical Device Clinical Studies & Clinical Evaluation for CE Marking	Dr. Monica Tocchi	A10049
Analytical Chemistry	Chiral Recognition and Separation Mechanisms	Prof. Nelu Grinberg	A24610