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Seminar: Supporting PIC/S Inspections and Audits with Electronic Quality Management Systems (eQMS)

30 September 2011

Time:  9:00 - 14:00

Ratanakosin Room (2nd floor), Four Seasons, Bangkok, Thailand

Factorytalk was proud to have completed together with our partner MasterControl a seminar on Supporting PIC/S Inspections and Audits using Electronic Quality Management Systems (eQMS). This event provided educational seminars and case studies to detail regulatory requirements (PIC/S) and expectations for Audits and Inspections. The program included a live system demonstration of key functions of an eQMS in the areas of Document Control, Training Management, Quality Events and Audit and Inspection and also a look to the next generation of such systems with mobile based solutions using an iPad.

 

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PRESENTATION SUMMARY

The seminar was very well attended by 38 paticipants from 28 leading pharmaceutical, Biotech and herbal remedy manufacturing companies in Thailand. The feedback was also excellent with 100% of participants requesting further invitations and information on Factorytalk`s future events and 100% of attendee`s rating the event as meeting and exceeding expectations.

 

 

 

Agenda

9:00 Start
Welcome and introductions
9:15 Session 1: Best practices for handling PIC/S inspections and supplier audits. By Dr. Tony Margetts including;
  • Regulatory expectations
  • Preparation for Inspection
  • Important tools for inspections and audits
  • Key points for audit management
10:00 Session 2 - Case study: The US FDA's implementation of MasterControl eQMS. By Mr. John Yarborough including;
  • How MasterControl ensures best practices and compliant Quality Management for the US FDA
  • Key benefits of eQMS for audit and inspection support
  • New developments in eQMS

10:45

 Coffee Break
11:15 Session 3 - eQMS demonstration and highlights. By Ms. Chompunut Apinan
  o Live demo of eQMS for handling audit processes and integration to quality events, documents and training management.
12:00 Lunch Break
13:00 Session 4 - Case study: Project approach for the first MasterControl eQMS implementation in Thailand. By Mr David Margetts
  • Project approach
  • Validation
  • Timelines
  • Benefits
13:30 Session 5 - Wrap-up, Q&A
14:00 Closure

Download Programme

Our printable Programme is available in .pdf format here.

 

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Use Adobe Acrobat Reader to view and print this file. If you do not have Adobe Acrobat, you can download it for free here.

 

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