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Practical GCP Compliance Auditing of Trials and Systems

Oct 22 2014 7:30AM - Oct 24 2014 3:30PM | Holiday Inn London Kensington Forum 97 Cromwell Road London SW7 4DN United Kingdom

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Overview 

This GCP auditing course is designed to provide practical training resulting in a harmonised, common audit methodology in Europe. The ICH GCP guideline implemented in the EU, Japan and the USA is being widely incorporated into guidelines worldwide. Systems audits, previously seen as "advanced auditing", have become a basic task of many audit groups and are an essential element of inspections in Europe.
The course material is regularly updated with the objective of experience sharing and a common professional approach in order to pave the way for mutual recognition and acceptance, reducing costs and stimulating efficiency, allowing faster medicinal product development to the benefit of the patients and health care.

What You Will Learn 

  • Regulatory framework EU and ICH
  • Quality management, defining quality, risk-based approach to audit and inspection
  • Trial system and vendor audit in practice
  • System audits
  • Communication of audit findings
  • Inspections by European and other authorities

Who Should Attend 

This course is designed to provide practical training for industry auditors and regulatory authority inspectors, who are faced with the challenging task of auditing or inspecting clinical trials and related systems. It will also be of interest to those with managerial responsibilities.

Learning Objectives 

At the conclusion of this course, participants should be able to:
  • Apply common audit methodology principles to clinical trials in Europe and other countries
  • Conduct trial specific and system audits
  • Formulate audit findings in clear and precise language
  • Discuss requirements for inspections

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

Hotel & Travel 

The DIA has blocked a limited number of rooms at the following hotel:

Holiday Inn London – Kensington Forum
97 Cromwell Road
SW7 4DN London
United Kingdom

Tel.: +44 207 341 8000
Website: http://www.hikensingtonforumhotel.co.uk/

at the rate of:
GBP 165.00 per room/night inclusive of breakfast and VAT.

In order to make your reservation, please contact the hotel directly at + 44 (0) 207 341 3355 and quote the booking reference ZNK.

Important: The room rate is available until 22 September 2014 or until the group block is sold-out, whichever comes first.

Contact Information 

Registration Questions
DIA Europe, Middle East and Africa
Contact center
Phone.: +41 61 225 51 51
Fax: +41 61 225 51 52
Monday-Friday 8:00-17:00 CET
diaeurope@diaeurope.org

Agenda and Event Logistics
Magdalena Lewandowska, Event Manager
Phone: +41 61 225 51 65
Fax: +41 61 225 51 52
magdalena.lewandowska@diaeurope.org

 

 

Faculty 

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Agenda  

Day 1 Wednesday, Oct 22, 2014

  • 7:30AM - 8:30AM

    REGISTRATION
  • 8:30AM - 9:00AM

    WELCOME
  • 9:00AM - 10:10AM

    Session 1: GCP REGULATORY FRAMEWORK IN EUROPE AND IN THE ICH
  • 10:10AM - 10:40AM

    COFFEE BREAK
  • 10:40AM - 12:20PM

    Session 1 continued: GCP REGULATORY FRAMEWORK IN EUROPE AND IN THE ICH
  • 12:20PM - 1:20PM

    LUNCH
  • 1:20PM - 2:45PM

    Session 2: AUDIT METHODOLOGY AND REPORTING
  • 2:45PM - 3:15PM

    COFFEE BREAK
  • 3:15PM - 5:15PM

    Session 2 continued: AUDIT METHODOLOGY AND REPORTING
  • 5:15PM - 5:30PM

    COURSE ASSESSMENT
  • 5:30PM - 6:30PM

    DRINKS RECEPTION

Day 2 Thursday, Oct 23, 2014

  • 8:30AM - 10:00AM

    Session 3: THE TRIAL AUDIT IN PRACTICE – INVESTIGATOR SITE
  • 10:00AM - 10:30AM

    COFFEE BREAK
  • 10:30AM - 12:00PM

    Session 3 continued: THE TRIAL AUDIT IN PRACTICE – INVESTIGATOR SITE
  • 12:00PM - 1:00PM

    LUNCH
  • 1:00PM - 2:50PM

    Session 4: COMPUTERS SYSTEMS AND DATA INTEGRITY
  • 2:50PM - 3:20PM

    COFFEE BREAK
  • 3:20PM - 5:15PM

    Session 5: SYSTEMS AUDITS
  • 5:15PM - 5:30PM

    COURSE ASSESSMENT

Day 3 Friday, Oct 24, 2014

  • 8:30AM - 10:00AM

    Session 6: VENDOR AUDITS
  • 10:00AM - 10:30AM

    COFFEE BREAK
  • 10:30AM - 12:00PM

    Session 6 continued: VENDOR AUDITS
  • 12:00PM - 12:15PM

    COURSE ASSESSMENT
  • 12:15PM - 1:15PM

    LUNCH
  • 1:15PM - 3:00PM

    Session 7: INSPECTIONS BY EUROPEAN AND THIRD COUNTRY AUTHORITIES
  • 3:00PM - 3:30PM

    FINAL DISCUSSION AND COURSE EVALUATION

Registration Fees 

Member

Charitable Nonprofit/Academia Member
€920.00
Member Government
€920.00
Member Standard
€1840.00

Non-Member

Charitable Nonprofit/Academia Nonmember
€1050.00
NonMember Government
€1050.00
NonMember Standard
€1970.00
Register Online

CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

  • Industry (Member/Non-member) = €200.00
  • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
  • Tutorial cancellation: €50.00

If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

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