Quality agreements are an integral part of outsourced GMP manufacturing and testing. Get a fundamental overview of what an effective quality agreement program looks like between you and your vendors and how to manage it.
While pharmaceutical and biotech companies outsource clinical trial tasks to CROs, Sponsors retain responsibility for the safety of subjects and regulatory requirement compliance and must ensure that the CRO is managing the trial correctly. Join our 90-minute interactive to identify the steps of conducting an effective audit to determine a CRO’s compliance to GCP requirements, study protocol and CRO/Sponsor Contractual Agreements.
Good Clinical Practice (GCP) inspections – announced or otherwise – are a fact of life and will affect your clinical research activities. Recognizing both US Food & Drug Administration (FDA) and European Medicines Agency (EMA) GCP inspection trends and procedures will keep your firm compliant. This course will show you how to prepare for, manage, and follow up with a health authority GCP inspection.
In this course, the instructor will give you a step-by-step process for preparing a Technical File or Design Dossier that is compliant with the current regulations and the proposed Annex III of the new European Medical Device Regulation.
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