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.

Faculty Nissan Cohen

Faculty Nissan Cohen

A recognized worldwide expert, with over 40 years’ experience, in high purity, ultrapure, reclaim and recycle water systems, and Total Organic Carbon (TOC) with profound expertise in instrumentation, automation, and organic contamination oxidation systems using ozone, UV, ion exchange and catalysts. Accomplished author of over 40 technical articles and major industry and regulatory publications published by Ultrapure Water, Pharmaceutical Technology, Pharmaceutical Engineering, Semiconductor International, the International Society for Pharmaceutical Engineering (ISPE), ASTM, and The Journal of the Institute of Environmental Sciences and Technology. 

Choose a Purchase Options


$299

Recorded Access Corporate Group

You'll have access to group log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for 1 location. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$389

MP3 Download - Training DVD

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.