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DTSTART:19700308T020000
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DTSTAMP:20260524T104212Z
SUMMARY:FDA regulations and the ICH GCP recommendations
DESCRIPTION:Overview:It will be important to see what the FDA regulati
 ons and the ICH GCP recommendations are in this regard. The key is tha
 t the PI and all clinical staff know and follow the research plan (Pro
 tocol) exactly as it is written. To do this is ethical research. To no
 t follow the protocol and document study conduct carelessly is folly.\
 nWhy should you Attend:All CRO's, Sites, and Sponsors of Clinical Rese
 arch involved in the drug and device development process have an inter
 est in being prepared for the audit process. Attending this Webinar is
  a good step toward learning the FDA processes and why the Sponsor's /
  CRO's Monitors are so important.\nAreas Covered in the Session:What d
 oes the FDA look at when Auditing/Inspecting a study?The Sponsor's res
 ponsibility in monitoring study conductComponents of a sponsor monitor
 ing system beyond SOPsThe nature of adequate oversight of all staff an
 d non-staffThe importance of Protocol knowledge in preventing errorsHo
 w do sites prepare for an audit / inspection\nWho Will Benefit:This We
 binar will provide invaluable assistance to all personnel in the Pharm
 aceutical, Biotechnology, and CRO industry Conducting Clinical Trials 
 including:Senior ManagementProject ManagersCRA ManagersQA/Compliance P
 ersons\nSpeaker Profile:Charles H. Pierce MD, PhD, FCP, CPI is a consu
 ltant in the Clinical Research / Drug-Device Development arena special
 izing in bringing the message of GCP Regulations and Investigator Resp
 onsibility to the entire investigative team to help them understand th
 e regulations as well as the ethics of research involving human subjec
 ts.\nEvent Fee: One Dial-in One Attendee Price: US$150.00\nContact Det
 ail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support
 @compliance4All.com\n\nFor more information visit https://medtechiq.ni
 ng.com/events/fda-regulations-and-the-ich-gcp-recommendations
DTSTART;TZID=America/New_York:20180306T100000
DTEND;TZID=America/New_York:20180306T113000
CATEGORIES:online
LOCATION:Online
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 1594LIVE?channel=medtechiq_Mar_2018_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=501594
 LIVE?channel=medtechiq_Mar_2018_SEO
CONTACT:Event Manager
ORGANIZER:Netzealous LLC DBA - Compliance4All
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562017127?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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