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DTSTAMP:20260523T044400Z
SUMMARY:When Conducting cGMP Regulatory Inspections 2018
DESCRIPTION:Overview:This webinar will cover the key areas of how ICH 
 Q7 was established, it's goals and objectives, expectations of the hea
 lthcare authorities involved and practical differences that you will e
 xperience in a GMP inspection of a facility by FDA, an EU Competent Au
 thority or PMDA.\nWhy should you Attend:It has often been stated that 
 \"FDA inspects for compliance; European inspectors inspect for adequat
 e science\". Yet GMPs have been enshrined into law for many countries 
 and a drug/biologic/medical device manufacturer should have a reasonab
 le expectation of all inspections being the same. ICH Q7 was establish
 ed by US / EU and Japan to harmonize inspections in their respective c
 ountries.\nAreas Covered in the Session:Where Inconsistencies Become a
  Problem: WHO, ICH, CountriesDiscrepancies in global expectationsAlign
 ment issuesKey Chapter ReviewsICH GMP organizationCategory reviews\nWh
 o Will Benefit:ManufacturingQuality ControlQuality AssuranceSenior Man
 agementProject Managers\nSpeaker Profile: Angela Bazigos is the CEO of
  Touchstone Technologies Inc. She has degrees in Microbiology and Comp
 uting and 40 years of experience in the Life Sciences, Healthcare & Pu
 blic Health Services. Experience combines Quality Assurance, Regulator
 y Compliance, Business Administration, Information Technology, Project
  Management, Clinical Lab Science, Microbiology, Food Safety & Turnaro
 unds.\nEvent Fee: One Dial-in One Attendee Price: US $150.00\nContact 
 Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: supp
 ort@compliance4All.com\n\nFor more information visit https://medtechiq
 .ning.com/events/when-conducting-cgmp-regulatory-inspections-2018
DTSTART;TZID=America/New_York:20180816T100000
DTEND;TZID=America/New_York:20180816T113000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 2024LIVE?channel=medtechiq_Aug_2018_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=502024
 LIVE?channel=medtechiq_Aug_2018_SEO
CONTACT:8004479407
ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia
 nce4all
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562016576?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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