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

Event Details

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

Time: October 4, 2018 at 9am to October 5, 2018 at 6pm
Location: Embassy Suites by Hilton Minneapolis Airport
Street: 7901 34th Ave South, Bloomington, MN 55425
City/Town: Minneapolis
Website or Map: https://www.globalcompliancep…
Phone: +1-800-447-9407
Event Type: seminar
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Aug 17, 2018

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Event Description

Course "US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Description:

This ICH GMP 2-Day seminar will provide your company the opportunity for 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.

The seminar will discuss in detail the:

  • Types of inspections done by US FDA, EMA and PMDA
  • Typical Audit Agenda that can be expected by each Authority
  • Scope of Audits.........how many auditors, how many days
  • When audits will likely occur
  • The expectation differences between inspections of API and Finished Product facilities
  • What areas of GMP become a focus by region
  • Typical audit observations by region [by Healthcare Authority]
  • Getting ready / preparation / self-inspection / mock audits
  • Managing the Audit.......the Importance of the QA Audit Generalist
  • Importance of SMEs [subject matter experts]
  • Processes & timelines
  • Acknowledging previous Healthcare Authority Audits.......when is it possible?
  • Examples of unique experiences encountered during audits

 

Location:  Minneapolis, MN Date: October 4th & 5th, 2018 and Time: 9:00 AM to 6:00 PM

Venue:  Embassy Suites by Hilton Minneapolis Airport   7901 34th Ave South, Bloomington, MN 55425

 

Price:

Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

Register now and save $200. (Early Bird)

Sponsorship Program benefits for seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901468SEMINAR?seo

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

 

 

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