Case Study-PowerPoint Presentation

Prompts:1. Company X is currently planning for its Phase 3 globalclinical trial initiation in 2021. One of the regions in which the trial willtake place is in Europe. Investigational medicinal product (IMP) use in Europerequires a Qualified Person (QP) to review and release (certification) the IMPfor clinical use. Company X is preparing for a QP audit in Q3, 2021. Pleasedescribe how you would prepare the company for its first QP audit from a GMP QAoperations perspective in support of cGMP manufacturing of drug substance anddrug product.
2. Assume that we have filed a BLA, and we expect to have aPre-Approval Inspection (PAI) in Q3, 2021. Please explain if you would preparethe PAI inspection in the same manner as the QP audit, or you would prepare itdifferently and why?