ISO 14155 GCP training

Invest in knowledge, train your staff

TRAINING

Introduction to MDSAP

Qserve Medical Device CRO and Consultancy offers you a hands-on GCP course that supports your everyday clinical operations and quality issues. Our course is set up especially for professionals in the medical device industry that work on clinical trials, PMCF studies and investigator-initiated trials (IIT), on a regular basis. During this 2-day course, the content of the ISO-14155 GCP standard for medical devices will be our guide. During the interactive sessions, we will discuss the practical implementation of the standard. The theory will be supported by real-life examples of difficulties and mistakes on the one hand, but also practical and clever solutions that avoid unnecessary bureaucratic burdens on the other hand. At the end of the day, you will go home with knowledge, GCP skills and practical ideas to implement directly within your organization, and you will receive your personal GCP certificate.

 

 

 

Program overview

Duration: 2 days

  • Typical clinical investigation terminology and GCP definitions
  • Differences and similarities between ISO-14155 for Medical devices, and other GCP standards (e.g. ICH-GCP)
  • Key changes in the upcoming ISO 14155-2019
  • Review and discuss the content of ISO 14155 (2011)
  • Investigator-initiated studies: compliance and value
  • Practical clinical investigation planning and execution, including real-world examples
  • Commonly seen pitfalls and how you can avoid them in your trials
  • Questionnaire and answers.

Learning objectives

  • To understand the content and role of the ISO-14155 standard in clinical investigation
  • To be able to implement the standard in a practical way during the preparation, execution and evaluation of clinical studies with medical devices
  • To learn from real-life examples that we come across in our everyday CRO and consultancy practice. Allowing you an exclusive look behind the scenes of several example trials.

 

Who should attend?

Clinical and regulatory personnel working at a medical device manufacturer, who are involved in the preparation, execution or evaluation of clinical investigations with medical devices.

 

Costs

We offer open enrolment, on-location, train-the-trainer formats. The price for this 2-day course is € 1350.- (regular) and contains the personal GCP certificate. 

Please contact us to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time. 

 

 

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