validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
Monday, January 1, 2018
Concepts in Cleaning and Disinfection of Controlled Environments / BioForum
Presenter: Renee Morley, Account Manager, Life Science Division for Steris Corporation This webinar will cover the topic of "designing and implementing an effective cleaning and disinfection program," and will bring clarity to the cleaning and disinfection process by covering industry trends, regulatory expectations, and essential elements needed to keep the cleanroom in control. You will learn how to choose and apply cleaners and disinfectants properly depending on the surface, environment and product, which will reduce labor costs and commodity usage. This will include sanitization of a Class 100/10,000 pharmaceutical cleanroom, proper equipment cleaning/disinfection procedures, and validation of disinfectant performance and application. In the end, you will be able to develop validation protocols and a proper cleaning and disinfection program to suit the needs of your company.
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Pharmaceutical Validation Documentation Requirements
Pharmaceutical validation is a critical process that ensures that pharmaceutical products meet the desired quality standards and are safe fo...
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K. Dashora, D. Singh, Swarnlata Saraf and S. Saraf *. Institute of Pharmacy, Pt.RavishankarShuklaUniversity, Raipur 492 010. *Author for ...
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Validation of the Autoclave is classified into the following 1.0 OQ – Operational Qualification 2.0 PQ – Performance Qualification The valid...
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Cold storage is a relatively simple cold room that is commonly used to store material between 2[degrees] to 8[degrees]C. Such cold rooms a...
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