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32784 Conferences

US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

Added by Referral on 2011-07-01

Conference Dates:

Start Date Start Date: 2011-07-22
Last Date Last Day: 2011-07-22

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email: referral@complianceonline.com
Address Address: 2600 E. Bayshore Road, Palo Alto, CA, 94303, United States
Phone Tel: +1-650-620-3915
Phone Fax: +1-650-963-2556

Conference Description:

Why Should You Attend:

This full-day ICH GMP training course will provide your company the opportunity for a comprehensive understanding of ICH GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan).

It will cover the key areas of how ICH 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.

Agenda: (All time in EDT):

10:00 am EDT to 12:00 noon (Agenda Sections I V below)
12:00 noon to 1:00 pm (Lunch)
1:00 pm to 3:00 pm (Agenda Sections VI X below)
3:00 to 3:15 pm (Break)
3:15 to 4:00 pm (Conclusions and Final Comments)
4:00 pm (Q&A Session)
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