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Now also available via Online live stream!

In the light of the current outbreak of COVID 19 across Europe, we have prepared an option to accommodate those delegates who will not be allowed to travel. The situation might fully be under control by the time when the training is planned to run, however we want to make sure everyone will get the same chance to take part in this unique training course.

Are you going to be able to attend the course in-person? Fantastic! We are looking forward to meeting you. Will you not be allowed to travel or do you feel it is safer to enjoy this unique course from the luxury of your office or home via your laptop, tablet or mobile? We obviously understand the situation and offer you the opportunity to join us via the online live stream enabling the mutual interaction between you and the trainer.

All sessions of this unique course online

Live interaction options between the delegates and trainer

Available via mobile, tablet or laptop

Reveal the full schedule, program, and trainer info!

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Meet the training leader

  • Mark Poulton
  • Former GCP Inspector at MHRA, Executive Director
  • Poulton Quality Solutions, United Kingdom
Learn more about the trainer

Course description

This practical course provides an indepth understanding of risk-based monitoring & auditing, remote auditing as well as implementing new GCP requirements.

The series of case studies & discussions will bring clarifications on risk-based approach, sponsor oversight and eTMF inspection readiness. You will learn about handling protocol deviation & data integrity issues, validation of electronic systems as well as about managing fraud.

Key Topics

Quality risk management & risk-based monitoring

Data integrity in clinical trials

IMP management

Sponsor oversight

Deviation & fraud

Computer systems validation & oversight

Key Takeaways


critical insight into regulatory inspections


the interpretation & implementation of EMA & MHRA GCP guidelines


yourself with computer systems validation requirements


about processes to ensure data integrity


clarification on requirements & audit targets


a risk-based approach, risk-based monitoring & risk-based auditing


tips for sponsor oversight


IMP management


how to manage deviations & fraud


clarification on CAPA

Join us in Vienna

Besides being the capital and largest city in Austria, Vienna is also the cultural, political and economic center of the country. Located at the crossroads between Eastern and Western Europe, the city unsurprisingly ranked six times in a row as the number one destination for international congresses and conventions. Vienna host many international organizations and is considered to be one of the best places for innovation.


Delegate Fee

from 2396 € Buy

Online Live Stream

from 1396 € Buy


Based on your specific needs and goals, we will build a training program that will equip your employees with the right set of skills and practical knowledge to achieve your organization's targets.

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