EU GMP Annex 1 (Draft 2020) Affects Aseptic Mfg

WEBINAR

The recent 2020 draft of EU GMP Annex 1, which regulates the manufacture, control and release of sterile pharmaceutical products in the EU, signals that there are comprehensive changes to come. This webinar will outline a holistic approach to ensure continued compliance, taking into account the expected changes, including the need for EM programs and procedures based on risk analysis.

If you operate aseptic manufacturing areas or facilities, such as ISO 5 cleanrooms in a traditional set up, RABS or isolators, you should watch this on-demand webinar.

Key Learning Objectives:

• The persons to involve in preparing the EM program and workflow and their roles within risk management
• How recent trends in manufacturing sterile products will impact your EM
• Managing your data and data analysis as well as the data cycle to allow you trending and predictive workflows