Date : Thursday, November 3, 2011 Time : 10:00 AM PDT | 01:00 PM EDT Duration : 60 Minutes Price : $245.00
Live Webinar Key Aspects of the Trial Master File and How to Pass FDA Inspection
Overview: This presentation will help with preparing the site and the study team with how to successfully prepare for an audit, how to identify risk of noncompliance, what to do before, during and after an audit. All these are done with the primary goal in mind: getting no audit findings. Areas Covered in the Session: l l l l l l l l
ICH guidelines and Good Clinical Practice (GCP) Role and responsibilities of clinical trial staff Key aspects of the Trial Master File Understanding compliance Most frequent audit findings Audit preparation Responding to audit findings Developing a CAPA
Click here to register for this webinar Who Will Benefit: l l l l l l l l l
Clinical Trial Sponsors Study Team CROs Study Team / Study Managers Clinical Team Leads CRAs Principal Investigators Site Managers and Study Coordinators New Clinical Research Coordinators New Principal Investigators Regulatory Compliance Associates and Managers
Register Now Instructor Profile: Calin Popa Director, Advanced Clinical Research Services Inc
Calin Enea Popa, MD, CCRA is the Founder and President of Advanced Clinical Research Service Inc. a Canadian full-service CRO that provides CRO services and training to FDA and Health Canada regulated industries. He provides ICH-GCP training and training for FDA and Health Canada regulations.He provides consulting services for the purpose of compliance review, drug accountability, site management, safety review, training site personnel, and to assure the integrity of clinical data. Performed site audits and site audit preparation. ...more
Related Products ISO 13485 Gap Analysis Toolkit
ISO 13485 Quality Manual
Intro to ISO 13485 Presentation Materials ISO 13485 Internal Auditor Checklist more...
Your Necessity is our Priority
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe