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Welcome to the European Forum for Good Clinical Practice
Activities  >  GCP Trainings  >  Audit Working Party Training
Face to Face Expert Training
Audit Working Party Training
Course Information: This is a one day training for those who are interested in learning techniques to strategize, plan and audit complex IT systems, and understand the common pitfalls when planning, conducting and reporting these audits. The training includes : Auditing virtual providers Auditing data from studies using wearable...
Description

Course Information:

This is a one day training for those who are interested in learning techniques to strategize, plan and audit complex IT systems, and understand the common pitfalls when planning, conducting and reporting these audits.

The training includes :

  • Auditing virtual providers
  • Auditing data from studies using wearable technology
  • Strategy and planning for complex IT vendor audits
  • The future data retention in clinical trials from eTMF to eCRF, to IRT & eCOA
  • An interactive workshop on audit trails


Target audience:
This training is aimed at experienced auditors; interaction will be a key part to the day.

Trainers:
Matt Jones, Digital Quality Associates

Matt Jones is the owner and principal consultant within Digital Quality Associates, Matt has worked in many facets of the healthcare industry over the last 20 years and shares a passion for compliance, patient safety, and data integrity.
Trev Simmons, TS CSV QA Limited
Trev Simmons is the owner and principal consultant of TS CSV QA Limited, building on his 25 years of experience in the pharmaceutical industry as an IT and Data Integrity specialist.

Guest Speaker:
Louise Mawer, EFGCP ‘s Audit Working Party Chair
Director, Mirabilitas Ltd, is a GxP quality assurance auditor and trainer, with over twenty years' experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and, more recently, Good Pharmacovigilance Practice.


Advantages for participants:

  • You will learn from highly experienced professionals in the field.
  • Participate in training with maximum 20 participants allowing for ongoing interaction with the trainers and answers to your questions.
  • Learn from practical examples.
  • Update yourself on new legislation and standards in the field.



Practical Information:
Date: Tuesday, 10 March 2020
Capacity: Small classes of maximum 20 participants
Location: EFGCP - 4 rue de l'Industrie, 1000 Brussels, Belgium

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If you have any question, send us an email to info@efgcp.eu
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EFGCP Secretariat
Rue de l'Industrie 4
B-1000 Brussels - Belgium
Tel +32 2 732 87 83