Annex 1 and its Comparison to Critical Utilities Compendial mandates: What does it all imply to the industry

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Who will Benefit

• Engineering personnel - all levels from junior engineers to directors and VPs
• Maintenance personnel for Critical Utilities and Water
• QA/QC personnel involved with critical utilities

Webinar Takeaway

• Description of Annex 1 by paragraph
• Assessment of Annex 1 in relation to existing Pharmacopeias
• Possible directions for any company marketing, selling, or manufacturing pharmaceuticals for the European community
• Identification of European regulators, country by country regulators, EDQM, EMA, and other regulatory bodies
• Expected date of Annex 1 enforcement
• Comparison of Annex 1 guidelines to mandated monographs and cGMP  

Key Learning Objectives

• Gain insight and knowledge of Annex 1, its implications to pharmaceutical manufacturers, and the expected European regulatory scrutiny.
• Understand the application of Annex 1 to all aspects of water used for Sterile Products and other medicinal products.
• Enforcement of Annex 1 by European regulators and country regulators
• This guideline is being treated as a mandate and its implication
• Nuanced differences between European and US Pharmacopeias
• Understanding of the influences on Annex 1 and its implications

Overview

Annex 1 is to be released formally in the very near future. This guidance for the Manufacture of Sterile Products is a regulatory enforceable document which is a de facto mandatory standard. This guidance has an extensive section on Critical Utilities and water. This document is already being cited by some European regulators, even before its formal release. The implications for industry when the adoption is implemented are very strict and dire. There are substantial influencers of this document and its application. Some individual European country regulators are stressing the application of Annex 1, even if it conflicts with the European Pharmacopeia or global harmonization of pharmacopeial mandates.  

Any company marketing, selling, producing, manufacturing, or compounding pharmaceuticals, APIs, and biologics for the European Community will be subject to scrutiny by European regulators, regardless of your country of origin, for production and manufacturing.

In the attendance of this webinar you will gain insight and knowledge of Annex 1, its implications to pharmaceutical manufacturers, and the expected European regulatory scrutiny.

Why Should You Attend

Any company marketing, selling, producing, manufacturing, or compounding pharmaceuticals, APIs, and biologics for the European Community will be subject to scrutiny by European regulators, regardless of your country of origin, for production and manufacturing.