Preparation For GCP Audits & Inspections

COURSE DETAILS

20 November 2014, Singapore 9.00am - 5.00pm (Reg. from 8.30am)
Singapore

Normal Course Fee: $979
Early Bird Special: $929 (Before 19 September 2014)
Group (>3): $899

 

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 This intense, interactive workshop provides an overview of Good Clinical Practice audits and regulatory inspections, what to expect, practical tips on how to best prepare for an audit or inspection, and best practice during and following an audit or inspection.

 

 

 

THE PROGRAM

This course will provide an overview of GCP audits and inspections.  The participant will be lead step by step through an audit or inspection and provided with practical tips on best practices at each stage, from preparation, during an audit or inspection, and follow up.  During the course, typical findings will be discussed and tips on how these findings can be avoided.  Interactive sessions will provide an opportunity to practice responses and follow up actions of a typical audit or inspection.

 

COURSE OBJECTIVE

  • The difference between audits and inspections;
  • The types of inspections at a sponsor or CRO or investigational site;
  • How best to prepare for an inspection;
  • Best practice for conduct during an inspection;
  • Common inspection findings and how to prevent their occurrence;
  • How to respond to inspection findings;
  • Construction of a plan for corrective and preventative actions.

 

WHO SHOULD JOIN

  • Clinical Research professionals and associates
  • Clinical Scientist / Basic Scientist
  • Clinical Investigators / Principal Investigators
  • Experienced Clinical Quality Assurance Professionals
  • Project Managers
  • Clinical Study Coordinators
  • Professionals in Clinical trials

 

TRAINER

Ms Trish Parry
BSc (Hons), FICR, CSci, CEO & Director, OTUS Clinical Services Ltd

Trish Parry has 30 years experience in the pharmaceutical industry and 23 years experience in clinical research. Trish has extensive experience in global monitoring and International clinical project management as a result of working in multi-national pharmaceutical companies including Genzyme, US Bioscience and Allergan and clinical research organisations including Quintiles. She has set up and maintained the European Clinical Quality and Training Department in Allergan and she is an experienced trainer in clinical research and GCP.

Trish is author of Statistics in Clinical Research (The Institute of Clinical Research, 2004, UK) and is on the Editorial Board of the UK based Institute of Clinical Research’s Journal, CRFocus. Trish is one of the founders of the UK based Institute of Clinical Research Trainers Forum. Read More


 

 

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