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:
Who Will Benefit:
Pharmaceutical personnel in:
From the Biopharmaceuticals IndustryInstructor Profile:
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 writer of over 35 technical articles published in Ultrapure Water, A2C2, Pharmaceutical Technology, Pharmaceutical Engineering, Semiconductor International, The Journal of the Institute of Environmental Sciences and Technology.
Co-Chairman, Contributing author and Chapter Leader of International Society for Pharmaceutical Engineering’s (ISPE) “Baseline Guide for Pharmaceutical Water and Steam Systems”. Revisions 1, 2, and 3
Co-chairman and Coordinating Author of the International Society for Pharmaceutical Engineering’s (ISPE) Good Practice Guide - “Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems”.
Contributing author to the International Society for Pharmaceutical Engineering’s (ISPE) Good Practice Guide on Ozone. Technical Editor of the Journal of the Institute of Environmental and Science Technology (IEST), Technical Reviewer of Pharmaceutical Engineering, Chairman of the Water and Steam Forum of ISPE, Founder/Chair of the Discussion Forums of ISPE, Former member of the Technical Advisory Board of A2C2 magazine.
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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