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Beer brewing is an art, and this ancient art is dying a slow death. With the advent of technology and the introduction of numerous catalysts for...

Beer brewing is an art, and this ancient art is dying a slow death. With the advent of technology and the introduction of numerous catalysts for...

Course "Verification vs. Validation - Product Process Software and QMS" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions. Why you should attend: This session helps participants: * Understand Verification and Validation, differences and how they work together; * Discuss recent regulatory expectations; * Know how to document a "risk-based" rationale, and use it in a resource-constrained environment; * Determine key "milestones" and "tasks" in a project; * Locate and document key subject "inputs"; * Compile "generic" Master and Individual Validation Plans; * Learn the key element of a Product V&V File/Protocol; * Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols; * Get a grasp of basic Test Case construction; * Understand sample sizes and their justification; * Learn the key elements of Software V&V expected by the FDA and how to document; * Deal with hardwa

In het onderzoek klagen Nederlanders over gebrek aan respect, een tekort aan tijd en aandacht en lange wachttijden. Ze geven de zorgsector gemiddeld een 6,5 als

Amyotrophic lateral sclerosis is a progressive neurodegenerative disorder. It affects the nerve cells in the central nervous system that controls the voluntary muscles. Muscle twitching, weakness, and stiff muscles are some of the symptoms of the amyotrophic lateral sclerosis. Amyotrophic lateral sclerosis is also known as Lou Gehrig's disease. The rising prevalence of amyotrophic lateral sclerosis is a prime factor driving growth of the amyotrophic lateral sclerosis treatment market. According to The Johns Hopkins University, it affects as many as 30,000 in the United States, with 5,000 new cases diagnosed each year. Estimates suggest that ALS is responsible for as many as five of every 100,000 deaths in people aged 20 or older. The growing geriatric population is increasing the prevalence of amyotrophic lateral sclerosis which is again propelling the growth of the amyotrophic lateral sclerosis treatment market. According to the United Nation, in 2019, there were 703 million persons aged 65 years or over in the global population. This number is projected to double to 1.5 billion in 2050. Read more @ https://sachinbhombe.blogspot.com/2021/03/amyotrophic-lateral-sclerosis-treatment.html