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| Articles by John Robinson |
251. The Food Safety Modernization Act (FSMA)
January 10, 2013
As one of the leading economies of the world with all-round development; the US attaches an extremely high degree of importance to food safety. Since large sections of the diverse population eats food that is prepared from various sources; the public has a tendency for contracting foodborne illnesse...
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252. The E-cigarette could be the next best thing to happen to smokers?
November 07, 2012
Description: The E-cigarette has the potential to alter smoking habits and wean heavy smokers away
Introduction Electronic cigarette (e-cigarette), also known as vaporize cigarette, is an electronic device powered by a battery that simulates a real cigarette by providin...
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253. FDA Guidance Regarding Clinical Trials for Foods, Food Ingredients, and Dietary Supplements
November 07, 2012
It is an understatement to say that the market for dietary supplementshas been growing at a great pace. More appropriate words to use to denote this growth, which has been in terms of both the range of products and increase in number of people using them could perhaps be “phenomenal” and“explosive”....
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254. 510K is a Pre-Market Notification (PMN) for new or modified medical devices.
November 07, 2012
Description: 510K certifies that the medical device is at least as safe and effective as a predicate device Brief Introduction to 510k
What is 510K? 510K is called as Pre-Market Notification (PMN) and is applicable for new or modified medical devices for marketability in the United States ...
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255. Are laws necessary for pain management?
November 07, 2012
Title: Pain is very subjective and individual Description: Pain management is deeply emotional and spiritual, making it difficult to promulgate laws for its management Are laws necessary for pain management? Pain management and existing laws have never been good friends. There are regul...
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256. API Process Inspection - what does the FDA expect?
November 07, 2012
Ironical as it may sound; there is no API-specific GMP guideline from the FDA! It has only some broad, yet clearly laid out rules and expectations, which have to be adhered to. The FDA and API Process Inspection Rules regarding what the FDA expects are mentioned clearly in the document that lays ...
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257. RAPS pre-approved webinar on "Avoiding an FDA Warning Letter with a Strong CAPA Program" from Globa
October 14, 2012
Summary:GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, “Avoiding an FDA Warning Letter with a Strong CAPA Program” on November 8. This 90-minute webinar earns up to 1.5 RAC credits towards a p...
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258. RAPS pre-approved webinar on "Ensuring Integrity and Security of Electronic Records for FDA Complia
October 14, 2012
Summary:GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, “Ensuring Integrity and Security of Electronic Records for FDA Compliance”, on November 27. Dr. Ludwig Huber, Director of Labcompliance a...
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259. RAPS pre-approved webinar on "Configuration Management and Change Control for Computer Systems" fro
October 14, 2012
Summary:GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, “Configuration Management and Change Control for Computer Systems” on November 14. This 75-minute webinar earns up to 1.25 RAC credits to...
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260. RAPS pre-approved webinar on "Implementing Medical Device Complaint Handling Systems" fromGlobalCom
October 14, 2012
Summary:A RAPS pre-approved webinar on the topic, “Implementing Medical Device Complaint Handling Systems”, is being organized on November 13 by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider.This webinarearns up to 1.00 RAC credits towards a partic...
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Author: John Robinson
