Online Safety Community

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

Export to Outlook or iCal (.ics)

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

 

 

 

Comment Wall

Comment

RSVP for US, EU and Japan GMP Requirements Practical ICH Area Differences, Healthcare Authority Inspection Focus to add comments!

Join Online Safety Community

Attending (1)

Take our poll!

Take our poll!

Forum

safety equipments in breweries 4 Replies

safety equipments in breweries -- kindly provide detailsContinue

Started by ajit. Last reply by Jen McDade yesterday.

Unusual Safety Tips 10 Replies

Please share some unusual but genuine safety precautions.My unusual safety tips - Don't drink sweet fruity juice while driving in the night as it contains sugar and sugar slows down your blood…Continue

Started by Arnold Brame. Last reply by Jen McDade yesterday.

Safety products 9 Replies

While working or at some work stations, employees are exposed to threats or at times suffer severe injuries. The safety of the employee should be the foremost priority. Safety equipment aids help in…Continue

Tags: equipments, and, products

Started by Enna Henry. Last reply by Jen McDade yesterday.

Talend Application Integration

APPLICATION INTEGRATION:Talend ESB and Application Integration delivers agile real-time integration of applications and data.Heterogeneous Application and Data IntegrationTalend’s open source ESB…Continue

Tags: york, new, certification, training, talend

Started by nicolewells on Friday.

Workplace health and safety Signs 4 Replies

You cannot ignore the importance of safety signs at your workplace. There is no scope to underestimate the important to health and…Continue

Tags: Prohibition, Workplace, Warning, Signs, Safety

Started by healthandsafetysigns. Last reply by Jen McDade Sep 17.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service