AllesEra Academy

Aspiring QPPV / LSR

Learn the Egyptian GVP seat well enough to hold it.

For pharmacists and PV officers who want the QPPV or LSR seat at an Egyptian MAH.

Modules

1. What the named seat actually is · ~20 min
   • What a QPPV or LSR is accountable for under Egyptian GVP, and why a company cannot delegate that to software
   • How the PSMF describes the system while the RMP covers one product, and when each one is asked for
   • Where your signature carries legal weight, and where a tool is only preparing the paperwork
2. The clocks an inspector will ask about · ~20 min
   • Serious ICSRs go to EDA in 15 calendar days and non-serious in 90, both counted from the day you became aware
   • Signal assessment runs 45 calendar days; an emerging safety issue runs 5 working days on the Egyptian business calendar
   • How to walk an inspector back through a deadline you met, using the trail rather than your memory
3. Where software stops and you start · ~15 min
   • Attestation is a human record of a judgment you made, which is a different thing from a digital signature
   • Submission to EDA and PVGA stays a human act performed by your organisation
   • EDA CCPD workshops carry the regulator's own attendance certificates, and this track is separate from those