Annex I: A Practical Perspective
Overview
This One-day in person course at NIBRT Dublin will take attendees through some of the most impactful changes to Annex I document for sterile medicinal drug product manufacturing in biopharma.
Trainees will first be given a high-level overview of Annex I in context of the regulatory environment and the key updates will be outlined.
Following this initial overview – trainees will spend the majority of the day in NIBRT’s pilot plant, including hands on time with NIBRT’s new state of the art fill finish line to get a practical perspective of key updates with a specific focus on:
- PUPSIT – How it’s done, why it matters and the challenges
- How to set-up environmental monitoring in a Grade A to B/C manufacturing environment (Fill Finish)
- Application of Annex I principles to the drug product manufacturing
Key topics covered
- Annex I – Updates and How they are applied
- PUPSIT – How to, the risks and challenges
- EM for Fill Finish – considerations and set-up
- Application of Annex I updates to drug product manufacture
Who should attend
This training course is ideal for companies or indivduals who need to upskill their operation staff on key updates to Annex I and how these changes will affect operations moving forward.
What do Attendees Obtain on Completion?
Attendees will receive a certificate of attendance.
Register
Course Format
Onsite Training at NIBRT
- 1 full day onsite training at NIBRT facility
Dates & Price
Dates:
- Course 1 07/10/2025
NIBRT- Onsite course
€995.005 Places Remaining
