Meet the training leader
- Mark Poulton
- Former GCP Inspector at MHRA, Executive Director
- Poulton Quality Solutions, United Kingdom
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
Key Takeaways
GET
critical insight into regulatory inspections
UNDERSTAND
the interpretation & implementation of EMA & MHRA GCP guidelines
FAMILIARIZE
yourself with computer systems validation requirements
LEARN
about processes to ensure data integrity
GAIN
clarification on requirements & audit targets
EXPLORE
a risk-based approach, risk-based monitoring & risk-based auditing
GET
tips for sponsor oversight
DISCUSS
IMP management
LEARN
how to manage deviations & fraud
GAIN
clarification on CAPA
Contact us
- Andrea Weber
- Sr. Manager for Pharma
- Phone: +421 257 272 232
- Email: event.inquiries@fleming.events