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Here's the recent articles submitted by adam fleming

Articles By adam fleming

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Mitigating The Pain Of An Rfp Process    Submitted as: Event Manager
Utmost care has to go into a financial institution's Cash Management and credit RFP process, which is quite a painful process. One needs to think about the whole process and get a thorough understanding of it before entering this exercise.(read entire article)
View : 77 Times
Category : Business

Part 11 Inspections From The Fda And Ways Of Steering Clear Of Inviting 483's And Warning Letters    Submitted as: Event Manager
The most important reasons for which citations get issued by the FDA relate to insufficient integrity, security and availability of electronic records, as well as validation of software and computer systems.(read entire article)
View : 46 Times
Category : Business

Post Market Surveillance Needs To Be Robust To Avoid Penal Regulatory Action    Submitted as: Event Manager
Post market surveillance (PMS) is a very important activity for manufacturers of medical devices. It needs utmost care in handling, because the FDA considers post market surveillance as one of its primary means for protecting public health.(read entire article)
View : 233 Times
Category : General

Putting In Place Food Processes That Facilitate Traceability And Recall    Submitted as: Event Manager
The Food Safety Modernization Act (FSMA) has strengthened the FDA's enforcement authority. The FDA now has the authority to not only mandate product recalls; the records and information they may request to see have increased as well. What has also gone up is the FDA's documentation review authority.(read entire article)
View : 108 Times
Category : Food, Cooking and Drink

Standardizing Transportation Procedures Is Necessary To Control Food Safety And Quality    Submitted as: Event Manager
The consequence of the inability to establish and keep required documentation is predictable: It makes food transporters liable to heavy fines and business closures.(read entire article)
View : 59 Times
Category : Business

The Criticality Of Determining The Right Sample Size    Submitted as: Event Manager
Among the most important aspects that need to be taken into consideration in any application is the sample size. The sample size, when taken accurately, can be a very reliable guide to the whole.(read entire article)
View : 91 Times
Category : Business

The Importance Of “management Responsibility” For Medical Device Companies    Submitted as: Event Manager
A webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer insights into how to prevent such actions from the FDA.(read entire article)
View : 80 Times
Category : Business

The Right Way Of Choosing Sample Sizes Based On Valid Statistical Rationale   By: adam fleming
Performing at least some verification testings or validation studies of design-outputs and/or manufacturing processes is essential for almost all manufacturing and development companies.(read entire article)
View : 103 Times
Category : Business

The Taxpayer Identification Number (tin) Matching Feature Of The Irs    Submitted as: Event Manager
The TIN matching is a pre-filing facility, since it is done before an entity files information returns.(read entire article)
View : 56 Times
Category : Business

The Ways Of Understanding, Calculating, And Using Statistical Power    Submitted as: Event Manager
A test of statistical significance, when it is conducted with the hope that the result will be non-significant, may be unacceptable to a regulatory agency unless the test had an acceptable level of “power”. The FDA typically requires a minimum of 80% power, and often requires something like 90% power.(read entire article)
View : 83 Times
Category : Business

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