Newsletter - December 6, 2018
FDA Implements NIPP to Sterile Injectables GMP Inspections: Other to Follow
Last week FDA announced that is has implemented a standardized, electronic semi-automated inspection protocol to GMP sites for sterile injectables with plans to expand the program to all GMP inspections or audits. The new GMP inspections protocol created under the New Inspections Protocol Project (NIPP)...Read More
GCP Training is Not Enough to Qualify Investigators: Tips for Sponsors from CTTI
Sponsors should look beyond GCP training to identify, groom and qualify investigators for their trials. A White paper on improving measures of investigator qualifications from the Clinical Trial Transformation Initiative (CTTI), a joint non-profit venture of the FDA and Duke University...Read More
FDA Implements NIPP to Sterile Injectables GMP Inspections: Other to Follow
Last week FDA announced that is has implemented a standardized, electronic semi-automated inspection protocol to GMP sites for sterile injectables with plans to expand the program to all GMP inspections or audits. The new GMP inspections protocol created under the New Inspections Protocol Project (NIPP)...Read More
GCP Training is Not Enough to Qualify Investigators: Tips for Sponsors from CTTI
Sponsors should look beyond GCP training to identify, groom and qualify investigators for their trials. A White paper on improving measures of investigator qualifications from the Clinical Trial Transformation Initiative (CTTI), a joint non-profit venture of the FDA and Duke University...Read More
