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When Conducting cGMP Regulatory Inspections 2018
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
-= series =-
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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
Doors open at 12:00am

General Admission: $150.00

Age
All Ages

Online<br> 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA<br> Fremont, 94539

18004479407

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