You already know the limits. This is about the evidence.
Annex 1 did not change the limits. It changed the standard of evidence you are expected to hold — and most sites are still building that file in arrears, one observation at a time.
Two days of working sessions built around that single shift: what inspectors are actually citing, what the micro evidence has to look like to answer it, and what you change when you get back.
Four reasons this is worth two days out of the plant
- 01
The evidence standard, not the limits
Sessions built from what is actually being cited — warning letters and EudraGMDP reports read against the micro evidence that answers them.
- 02
Regulators in the room, on the record and off it
US FDA and USP addresses, plus an Indian regulator roundtable under Chatham House rule where the questions are anonymous.
- 03
Working sessions, not lectures
A live smoke study, a two-day ballroom EM study, an investigation clinic with inspector cross-examination, and statistics worked on stage.
- 04
Something to act on by Monday
A bound workbook of templates and decision trees, and a closing panel where every speaker commits to three changes.
Who should attend
Open a role to see what the two days give that role specifically.
- The evidence session: what is actually being cited in FDA warning letters and EudraGMDP reports, and the micro evidence that answers it
- EM qualification defended live under regulator challenge
- Rapid method validation — accuracy and LOQ calculated on stage, not described
The bound workbook
Every delegate leaves with a printed workbook of the templates, decision trees and frameworks used on stage — not a copy of the slides.
- EM qualification and sampling-plan justification templates
- Investigation decision trees for excursions and media fill failures
- Rapid method validation worksheets with worked accuracy and LOQ examples
- The objectionable organism risk assessment framework used in the live vote
- A themes note from the regulator roundtable, co-badged and published after the event
One avoided observation pays for the room. Every session closes with a named deliverable, and the closing panel commits each speaker to three changes a site can make on Monday morning.