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Langue du site : Français - English
Réf : 28921
Evènement :Surviving an FDA Sponsor Inspection - Training for Success

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

This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.

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

Plan et itinéraire
Adresse de la conférence :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
California, États-Unis
Tél : +1-888-717-2436
Plan et itinéraire

Renseignements

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Précisions

Surviving an FDA Sponsor Inspection - Training for Success Hôpital - Management
fda sponsor inspection training program, sponsor sop and tmf options, cro contractual delegation, fda sponsor inspectional procedures
Professionnels, CQA Regulatory personnel Clinical operations, CRA Director and upper level pharma research management Investigators and research management staff Clinical Project Manager Regulatory Affairs Compliance Manager Trial Master File Manager
10 -- --
English

Divers

Pour plus d'informations sur Surviving an FDA Sponsor Inspection - Training for Success, veuillez contacter ComplianceOnline

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