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.
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
how to manage deviations & fraud
clarification on CAPA