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When Conducting cGMP Regulatory Inspections 2018
Presented By Netzealous LLC DBA - Compliance4All
Thursday, August 16th at 10:00am PST
Online sale ends: 08/16/18 at 9:00am PST
Online
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA
Fremont, CA 94539
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Description
Overview: This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA. Why should you Attend: It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science". Yet GMPs have been enshrined into law for many countries and a drug/biologic/medical device manufacturer should have a reasonable expectation of all inspections being the same. ICH Q7 was established by US / EU and Japan to harmonize inspections in their respective countries. Areas Covered in the Session: Where Inconsistencies Become a Problem: WHO, ICH, Countries Discrepancies in global expectations Alignment issues Key Chapter Reviews ICH GMP organization Category reviews Who Will Benefit: Manufacturing Quality Control Quality Assurance Senior Management Project Managers Speaker Profile: Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Event Fee: One Dial-in One Attendee Price: US $150.00 Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com |
Presented By
10:00am to 11:30am
General Admission: $150.00
All Ages
50 18004479407 UPCOMING EVENTS
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