Hi everyone! I have upcoming Sponsor audit and created this topic in order to discuss most common audit questions during GCP audits. Also I would like to offer someone who is experienced on that topic and have possibility to organize with me several video sessions in order to prepare myself. We can discuss relevant payment for these sessions Many thank in advance
I have got relevant experience of working as QA Head in the GCP (Good Clinical Practice) environment for auditing Clinical trials phase-1, 2, 3, & 4, Bioavailability and Bioequivalence studies of pharmaceutical products. I have also faced many regulatory inspections during my career as a Quality Head such as USFDA, MHRA-UK, EMA-EU, ANVISA-Brazil, Thai-MOH, ANSM-France, Turkey-MOH, WHO-Geneva and Indian Regulatory body (CDSCO). Therefore I can guide you on the GCP aspects.
Please contact me on my personal email ID [email protected]