Date :Mardi 19 Février 2019
Lieu :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, California, États-Unis
Type :Conférence & Séminaire - Audience Internationale
Accréditation :--
Informations
Editorial
Objectives
The sponsor clinical operations staff guided the sponsor and investigator site staff through the FDA inspection/audit process. The result was a passed FDA sponsor inspection and approved NDA. There were no FDA warning letters issued to any investigators.
This webinar will discuss how seemingly insurmountable obstacles to a successful FDA sponsor inspection were resolved and how you can apply these lessons to your next FDA sponsor inspection
Program
- FDA inspectional procedures; What sponsor staff are audit targets and how FDA inspections are performed
- Sponsor SOP and TMF options that work and do not work toward complying with FDA documentation requirement
- FDA sponsor inspection objectives and perspectives
- Typical and common FDA questions and how not to respond
- The impact of CRO contractual delegation of project responsibilities on sponsor regulatory obligations
- Audit of sponsor records and training of sponsor staff as a positive step in preparing for the inspection
Lieu
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
California, États-Unis
Tél : +1-888-717-2436
Plan et itinéraire
Renseignements
Annonceur
Précisions
Divers
Pour plus d'informations sur Surviving an FDA Sponsor Inspection - Training for Success, veuillez contacter ComplianceOnline
Pour afficher le site de l'annonceur, obtenir une lettre d'invitation, vous devez être connecté
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