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EU-GMP ANNEX 1

GAMP5

GMP

GMP, GAMP5, and 21CFR11…

ISO-14644

USP

Format

BLOG

TECH PAPER

VIDEO

WEBINAR

Publication Year

Dec 19, 2023

EU GMP Annex 1 Continuous Viable Monitoring

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Oct 25, 2023

Understanding ISO TR 14644-21

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Mar 30, 2023

How To Prepare A Contamination Control Strategy Document as Per New GMP Annex 1

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Nov 23, 2022

Microbiology & Bio contamination Control in Cleanrooms From EN ISO 14698 to a new EN 17141

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Nov 7, 2022

Overview of GMP Annex 1 and its impact on Environmental Monitoring

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Sep 22, 2022

Cleanroom Validation from URS to PQ; ISPE GAMP5 2022 Edition & V Scheme Application for Cleanroom Monitoring Systems

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Jun 30, 2022

What is 21CFR11 and why is it so important in maintaining Data Integrity?

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Apr 28, 2022

What is GAMP and why is it so important in Cleanroom Manufacturing?

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Feb 23, 2022

Understanding and Applying USP 788 Best Practices

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Sep 27, 2021

Active Air Sampling Technology & ISO 14698

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Sep 8, 2021

ISO 14644-1:2015 and ISO 14644:2-2015 Review

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Jun 23, 2021

EN17141 “Bio contamination Control” and Microbiology in Cleanrooms & Controlled Environments

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Jun 16, 2021

Let’s Prepare an ISO 14644-1 and GMP Annex 1 Cleanroom Classification Report Together

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May 13, 2021

GMP Annex 1 2020 Draft: Effects on cleanroom classification and monitoring

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Mar 17, 2021

How to Prepare a Risk Based Cleanroom Monitoring Plan as per ISO 14644-2:2015

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Feb 5, 2021

ISO 14644-3:2019 Cleanrooms and Associated Controlled Environments-Test Methods

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Jan 22, 2021

GMP Annex1 2020 Draft and its Effect on Cleanroom Classification and Monitoring

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Aug 26, 2020

Prevent Failure by Designing Your Cleanroom Monitoring System to Meet cGMP

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Jul 22, 2020

Performance Qualification of Environmental Monitoring Systems

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Jul 17, 2019

ISO 14644:2-2015 Creating, Implementing, and Maintaining a Monitoring Plan

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