BEGIN:VCALENDAR
PRODID:NingEventWidget-v1
VERSION:2.0
METHOD:PUBLISH
BEGIN:VTIMEZONE
TZID:America/New_York
X-LIC-LOCATION:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:19700308T020000
RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:19701101T020000
RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
UID:2140535:Event:74428
DTSTAMP:20260519T065952Z
SUMMARY:FDA Issues and its FDA Data Integrity - 2017
DESCRIPTION:Overview:Many of the data integrity issues that plagued th
 e US drug and biologics industry were eliminated by detailed regulatio
 ns and stricter enforcement, but many of the problems have resurfaced 
 in recent years among the multitude of foreign manufacturers whoare no
 t familiar with US practices.\nAreas Covered in the Session:Important 
 Regulations related to Data Integrity, including laws related to the e
 ffects of bad dataGuidance Documents related to Data IntegrityRequirem
 ents for Computerized Instrument OutputsDefinition of Data Integrity T
 ermsImportance of Audit TrailsExamples of Violations 483s taken from W
 arning Letters\nWho Will Benefit:Quality Control and Quality Assurance
  WorkersRegulatory Affairs PersonnelProduct Development WorkersPersonn
 el Planning Clinical StudiesManufacturing Supervisors\nSpeaker Profile
 :Steven S. Kuwahara , Ph.D. is the founder and Principal of GXP BioTec
 hnology LLC, a consulting firm that works in the areas covered by the 
 GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30
  years of experience in supervising quality control laboratories, incl
 uding an animal testing facility, and in performing GLP and GMP audits
  of internal and external testing laboratories . Steve has participate
 d in the development of drugs and biologicals through all phases of cl
 inical research and final product production.\nEvent Cost & Details:On
 e Dial-in One Attendee Price: US$150.00\nContact Detail:Compliance4All
  DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.co
 m\n\nFor more information visit https://medtechiq.ning.com/events/fda-
 issues-and-its-fda-data-integrity-2017
DTSTART;TZID=America/New_York:20170901T100000
DTEND;TZID=America/New_York:20170901T113000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 1432LIVE?channel=medtechiq_Sep_2017_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=501432
 LIVE?channel=medtechiq_Sep_2017_SEO
CONTACT:8004479407
ORGANIZER:Event Manager
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562014518?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
END:VEVENT
END:VCALENDAR