Webinars

FMEA Risk Assessment Workshop

Learn how to prepare for a successful audit by attending this 3 hour online workshop, taught by a professional risk assessment advisor.

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The New EU GMP Annex 1 Revision 2017: Review, Insights and Feedback

Attend to get a first look and review of the Annex 1 draft, released for comments. Our experts will be providing their comments and will want to hear your thoughts on this new version. 

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Combining Particle and Microbial Sensors to Fully Meet Regulatory Requirements

Monitoring of nonviable and viable particles in a cleanroom is critical to meet regulatory requirements. An environmental monitoring system effectively collects, manages and reports on data from both types of sensors. 

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Reducing Sampling Variation in Offline Particle Counting

Best known methods to minimize external contamination in the sample are presented to support data optimization. Customers are encouraged to incorporate these concepts in their own process development. 

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Steps to Ensuring a Successful Audit - Effective Risk Assessment Design Webinar

When designing a process, product quality is an important measure of success. To ensure product quality, it is imperative that the environment is monitored for contamination.

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Effective Compressed Gas Contamination Monitoring: Particles and Microbials

Control of the environment in which pharmaceutical products are manufactured is a key element of Good Manufacturing Practices (GMP). Monitoring of particles & microorganisms in manufacturing cleanrooms, Restricted-Access Barrier Systems (RABS), and isolators consists of clearly defined components.

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The New EU GMP Annex 1 Revision 2017: Review, Insights and Feedback

Download this webianr to get a first look and review of the Annex 1 draft, released for comments. Our experts will be providing their comments and will want to hear your thoughts on this new version. 

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The Significance and Detection of VBNC Microorganisms

Microbiologists have long recognized there are significant numbers of microorganisms in the environment that cannot be cultured successfully with conventional methods. A wide range of nonsporulating gram-negative and gram-positive bacteria can exist in the Viable But Non Culturable state.

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Understanding 21 CFR 11 and Data Integrity Regulations

Today, both the MHRA and FDA are highly focused on data integrity and currently discourage methods by which data is recorded manually. 

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Understanding ISO 21501-4: Particle Counter Calibration

ISO 21501-4 has two main goals; to improve instrument-to-instrument data correlation and count accuracy, and to enhance compliance with ISO 14644.

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Understanding ISO Standards: 14644-2:2015 Cleanroom Monitoring (English)

Learn about ISO 14644-2:2015 and how it affects your clean environment monitoring.

ISO 14644-2:2015 is not only a new standard with which to be compliant, but is also a beneficial tool to use in achieving mature cleanroom environmental control.

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USP 1116 & Implications of Measuring Microbial Recovery Rates

Attend this webinar to learn about the USP 1116 changes and how this impacts microbial control and monitoring in aseptic processing environments.

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ISO 14644-1:2015 Revisions Summary

Learn about ISO 14644-1:2015 and how it affects your clean environment monitoring.

The recent revision of ISO 14644-1 introduced several changes for cleanroom classification and monitoring guidelines. Join us for a review of the changes and how they affect your environment monitoring.

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Learn efficient troubleshooting techniques for Airborne Molecular Contamination monitoring

Decreasing the time to detect, contain and mitigate very low levels of Airborne Molecular Contamination (AMC) is critical for high tech manufacturers.

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Identifying the best rapid microbial monitoring solution for your critical & ISO 5/ Grade A surfaces

Managers need the assurance that the surfaces in their facilities are aseptic. Gaining that knowledge in a fast and accurate way that also provides results for all surfaces, even and uneven, is a challenge.

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