GMP Up-dates

Course description

It is a GMP requirement that staff are continuously trained in GMP, and the FDA expects that at least one annual activity can be documented. This course can meet this requirement.  During this 3 hour on-line training you will learn what is hot-or-not, which updates have been made in the GMP’s and what observation regulatory agencies have issued around the world.

Get an introduction to changes and updates within the GMP rules in the EU, US and a presentation of trends in:

• Warning Letters
• 483 observationer
• Recalls

We will look at what is trending right now as the most cited topic in Warning Letters from the FDA and what topics as single observations have triggered Warning Letter’s

In the course we look at, among other things:

• FDA Enforcement and Compliance Trends
• Data Integrity – PIC/S 041
• Inspectors Working Group (EMA) – coming up-dated in EU GMP
• EU GMP Annex 1

Course goal

• The updated rules within the EU and US GMP
• Briefing on GMP rules that are in consultation
• Trends inden for GMP

Who should participate

This course is intended for professionals with a basic or extensive knowledge of the GMP rules in the EU and US, and who want to know about the updates in cGMP. The course will give participants the opportunity to assess which new requirements will affect their own business and how to comply with the new rules.

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