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You will learn how to interpret the regulations, standards, and guidance documents; correctly apply the principles of risk management; create qualification protocols (IQ, OQ, PQ); and identify statistical methods and tools when implementing and maintaining process validation activities. Bring any of our classes to your location - Oriel STAT A MATRIX on-site training is the perfect solution for training groups of five or more employees or launching a companywide training effort.You’ll also evaluate real-world process validation examples and warning letters, as well as learn best practices for the practical application of process validation in medical device manufacturing. It's cost-effective, completely customizable, and absolutely hassle-free.Most consumers look for certification from quality management systems, like ISO, before they even consider buying a product; so an incorrect system of validating your equipment can threaten your adherence to industry norms, as well as your certifications and compliances.These are just a few things that almost every validation process should incorporate.Equipment validation is a term used to describe a set of independent procedures that are used to check if a product meets the specifications and requirements of its intended purposes.Regulatory agencies around the world have strict requirements for quality, procedures, performance testing, safety checks and the like, for a wide range of products.Half-day refresher courses for GMP, Active Pharmaceutical Ingredients (API) and contamination control are also available.
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The Understanding Validation (1 Day) Training is a foundation-based course which will help increase your understanding of what validation means to the healthcare manufacturing industry.
When you have completed the course, you will have an appreciation of the different terms and application of validation for pharmaceutical and medical device manufacturers.
” Schneider Electric“Would definitely recommend course to management for use by other staff.” Seal Sands Chemicals“Good course.” Conva Tec Ltd“Good re-cap plus some new information regarding PLCs was useful.” Teva Runcorn“The course pulled together the whole validation process in a simple and clear manner.” Open course delegate“The course gave a useful overview of validation and helped put certain elements into a clearer context.” Open course delegate“Excellent course.
Covered everything and lots more than I was expecting it to.
Depending on the industry the instruments are built for and the individual requirements of the validation, other aspects might also need to be taken into account.