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SUMMARY:How to be Efficient and Compliant with Part 11, Validation
DESCRIPTION:\nThis interactive two-day course explores proven techniqu
 es for reducing costs associated with implementing, using, and maintai
 ning computer systems in regulated environments.\nMany companies are o
 utsourcing IT resources and getting involved with Software as a Servic
 e (SaaS) and cloud computing. These vendors are not regulated and ther
 efore regulated companies must ensure compliance for both infrastructu
 re qualification and computer system validation. It is the regulated c
 ompany that wants to avoid FDA form 483s and warning letters. The semi
 nar is intended for regulated companies, software vendors, and SaaS/Cl
 oud providers.\nThe instructor addresses the latest computer system in
 dustry standards for data security, data transfer, audit trails, elect
 ronic records and signatures, software validation, and computer system
  validation.\nToday the FDA performs both GxP and Part 11 inspections,
  the Europeans have released an updated Annex 11 regulation that expan
 ds Part 11 requirements and companies must update their systems and pr
 ocesses to maintain compliance.\nThis seminar will help you understand
  the specific requirements associated with local and SaaS/cloud hostin
 g solutions.\nNearly every computerized system used in laboratory, cli
 nical, manufacturing settings and in the quality process has to be val
 idated.\nParticipants learn how to decrease software implementation ti
 mes and lower costs using a 10-step risk-based approach to computer sy
 stem validation.\nFinally, the instructor reviews recent FDA inspectio
 n trends and discusses how to streamline document authoring, revision,
  review, and approval.\nThis course benefits anyone that uses computer
  systems to perform their job functions and is ideal for regulatory, c
 linical, and IT professionals working in the health care, clinical tri
 al, biopharmaceutical, and medical device sectors. It is essential for
  software vendors, auditors, and quality staff involved in GxP applica
 tions.\n\n\nFor more information visit https://medtechiq.ning.com/even
 ts/how-to-be-efficient-and-compliant-with-part-11-validation
DTSTART;TZID=America/New_York:20190204T080000
DTEND;TZID=America/New_York:20190205T170000
CATEGORIES:seminar
LOCATION:Four Points by Sheraton Boston Logan Airport Revere, MA
WEBSITE:https://www.globalcompliancepanel.com/seminar/how-to-be-effici
 ent-and-compliant-with-part-11-validation-and-SaaS-Cloud-901921SEMINAR
 ?medtechiq-FEB-SEO-2019
URL:https://www.globalcompliancepanel.com/seminar/how-to-be-efficient-
 and-compliant-with-part-11-validation-and-SaaS-Cloud-901921SEMINAR?med
 techiq-FEB-SEO-2019
CONTACT:18004479407
ORGANIZER;CN="John Robinson":https://medtechiq.ning.com/profile/JohnRo
 binson
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/162357504?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob
 inson":https://medtechiq.ning.com/profile/JohnRobinson
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