Thursday, August 16 | 10:00 am - 11:30 am
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