The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: August 16, 2018 from 10am to 11:30am
Street: 161 Mission Falls Lane, Suite 216,
Website or Map: http://www.compliance4all.com…
Event Type: webinar
Organized By: Adam Fleming
Latest Activity: Jun 5
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
Key Chapter Reviews
ICH GMP organization
Who Will Benefit:
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
Compliance4All DBA NetZealous,