Annex 1 is a European mandate for Sterile Products Manufacturing but encompasses many critical utilities including pharmaceutical water. The current version is under revision and may be contrary to some Pharmacopeias. Annex 1 will be enforced by PIC/S, EMEA, and other European regulators. This is a very important subject to anyone manufacturing products either in or for the European market.
Without the knowledge of how Annex 1 may influence your operations, the resulting knowledge gap could cause European regulatory problems. All manufacturers of pharmaceutical products sold or marketed in the European Union as susceptible to European regulatory audits.
Although Pharmaceutical manufacturing is a global industry, understanding the regional or local mandates is imperative to ensure regulatory compliance. You will understand and learn how to ensure your compliance to the compendial and mandated regulatory enforcements regarding all classifications of pharmaceutical water. Are you prepared to tackle the Annex 1 mandate?
The adoption of Annex 1 may cause difficulty in compliance for European and global manufacturers whose products are marketed in the European market. You will understand how to navigate the tightrope between foreign regulatory needs and fulfilling you domestic regulatory needs. Additionally, this presentation will identify the regulatory players for composition and enforcement of this mandate. We will identify the pharmacopeial mandates and the conflicts of Annex 1’s adoption in its current proposed revision.
Although Pharmaceutical manufacturing is a global industry, understanding the regional or local mandates is imperative to ensure regulatory compliance. You will understand and learn how to ensure your compliance to the compendial and mandated regulatory enforcements.
Why Should You Attend:
Annex 1 is technically written for Sterile Product manufacturing. However, enforcement includes critical utilities and pharmaceutical water systems. It is imperative to understand how Annex 1 may influence your products’ manufacturing, documentation, processes, and production.Without the knowledge of how Annex 1 may influence your operations, the resulting knowledge gap could cause European regulatory problems. All manufacturers of pharmaceutical products sold or marketed in the European Union as susceptible to European regulatory audits.
Although Pharmaceutical manufacturing is a global industry, understanding the regional or local mandates is imperative to ensure regulatory compliance. You will understand and learn how to ensure your compliance to the compendial and mandated regulatory enforcements regarding all classifications of pharmaceutical water. Are you prepared to tackle the Annex 1 mandate?
The adoption of Annex 1 may cause difficulty in compliance for European and global manufacturers whose products are marketed in the European market. You will understand how to navigate the tightrope between foreign regulatory needs and fulfilling you domestic regulatory needs. Additionally, this presentation will identify the regulatory players for composition and enforcement of this mandate. We will identify the pharmacopeial mandates and the conflicts of Annex 1’s adoption in its current proposed revision.
Although Pharmaceutical manufacturing is a global industry, understanding the regional or local mandates is imperative to ensure regulatory compliance. You will understand and learn how to ensure your compliance to the compendial and mandated regulatory enforcements.
Areas Covered in the Webinar:
- Annex 1 review of current proposed revision 2019
- Comparison to Annex 1 2008
- Identification of European and International regulatory agencies involved with Annex 1
- Discussion on individual country regulatory enforcement outside of EU
- Comparison of Annex 1 to European Pharmacopeia (Eur. Ph.)
- Comparison of Annex 1 to United States Pharmacopeia
- Conflicts and discrepancies identification between Annex 1 and Pharmacopeias
- How to ensure your pharmaceutical water systems will comply with Annex 1
Who Will Benefit:
Pharmaceutical personnel in:- Engineering, water systems, critical utilities, QA/QC, operations, production, maintenance, And Engineering management
- From the Biopharmaceuticals Industry
Course Provider
Nissan Cohen,
