Cleaning Archives - Page 4 of 5

Category: Cleaning

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Digital Cleaning Validation Lifecycle

Presented by: Rui Almedia, Director, Product Life Cycle Management Services, ValGenesis. Inc.Cleaning validation is a complex process. Over the years, the industry has moved on with a structured risk based lifecycle approach following FDA Process Validation Lifecycle principal guidance. Using old processes, it remains a challenge to eliminate human errors. This presentation shows how to […]

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Environmental Monitoring – Risk-Based Program Development, Data Trending, and Analysis HVAC System Design and Validation

A risk-based environmental monitoring is a critical component for effective cleaning and disinfection programs. This virtual seminar outlines risk-based program development and implementation; data trending and analysis; and HVAC systems design and validation to ensure your facility is in a state of control. Don’t’ miss industry’s EM leading experts, Ziva Abraham of Microrite, Sheba Zaman […]

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Risk-Based Cleaning Validation

Handout_Risk-Based Cleaning ValidationDownload

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Risk-Based EM Sampling Strategy – Using the Process Risk Control Strategy to Determine EM Sampling Strategy

Join us as we discuss four different ways of using the process risk control strategy to determine EM sampling.Part 1 – Holistic Process Risk Control Strategy• Process Risk Assessment and establishing a holistic riskcontrol strategy• Environmental risks and risk controlsPart 2 – Environmental CQAs and CPPs• Environmental CPPs and the product CQAs impacted• ISO classifications […]

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Accelerate Early-phase Biopharmaceutical Manufacturing with Cleanrooms on Demand – How to Stay Resilient After 2020

There is no doubting the impact that 2020 has had on our industry, our country, and our world. With more than 700 therapeutics in the pipeline for COVID-19 alone, speed-to-clinic is a top priority for early-phase manufacturers. There are myriad considerations when transitioning from the lab to clinical operations, specifically for emerging industries such as […]

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Category: Cleaning

Digital Cleaning Validation Lifecycle

Environmental Monitoring – Risk-Based Program Development, Data Trending, and Analysis HVAC System Design and Validation

Risk-Based Cleaning Validation

Risk-Based EM Sampling Strategy – Using the Process Risk Control Strategy to Determine EM Sampling Strategy

Accelerate Early-phase Biopharmaceutical Manufacturing with Cleanrooms on Demand – How to Stay Resilient After 2020

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