The body size differences are paralleled by maturational changes. The smaller body of an infant or neonate is substantially different physiologically from that of an adult. Congenital defects, genetic variance, and developmental issues are of greater concern to pediatricians than they often are to adult physicians.
A major difference between pediatrics and adult medicine is that children are minors and, in most jurisdictions, cannot make decisions for themselves. The issues of guardianship, privacy, legal responsibility and informed consent must always be considered in every pediatric procedure. In a sense, pediatricians often have to treat the parents and sometimes, the family, rather than just the child. Adolescents are in their own legal class, having rights to their own health care decisions in certain circumstances. In basic terms, pediatricians take care of all of the children's needs from emotional support to medical support.
Wheelchair india as Pediatric Wheelchair Manufacturers and Pediatric Wheelchair supplier sale at low cost - price, We Sale online Pediatric Powered Wheelchair and Pediatric Electric Wheelchair at wholesale prices...
Course "Marketing Products without Getting Hammered by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral.
This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion.
Why should you attend:
If you go "off label" with advertising and promotion, you become embroiled in FDA's advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, FDA's law and regulations are extensive and have violated Constitutional protections. Depending on your point of FDA's promotion and advertising requirements can help you or hurt you? There is an inherent conflict in interests. In any case, you need to identify practical criteria to make marketing decisions. That begs the question of whether or not marketing managers and regulatory affairs managers will even try to agree on an issue. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. CDER has esta
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
"Medical Devices Survey 2013-2014: Market Trends, Marketing Spend and Sales Strategies in the Global Medical Devices Industry" is a new report by canadean that analyzes how medical devices industry supplier companies' media spend, marketing and sales strategies and practices, and business planning are set to change in 2013-2014.
Many people wonder how to Buy marijuana online? Universal Marijuana Store is the leading Cannabis shop online for providing cannabis and medical marijuana for sale.
We offer the highest quality, reliable weed edibles for sale. Buy edibles online and Experience the most efficient shipping experience with us. Order us online at universalmarijuanastore@gmail.com