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| Articles by John Robinson |
211. Meeting FDA requirements for OTC Drug Labeling - Webinar by GlobalCompliancePanel
November 24, 2013
Overview: The webinar will help participants review and understand FDA requirements for OTC Drug labeling and compliance. OTC Monographs and their importance to OTC Drug marketing in the U.S. will also be covered.
Why Should You Attend: Anyone who wants to market OTC drugs in the U.S.A. and...
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212. Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends - Webinar by
November 24, 2013
Overview: CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.
Industry is now using various risk-based approaches and tools to set-up, deploy and maintain their CAPA progra...
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213. HACCP Training for Food Processing Team Members - Webinar by GlobalCompliancePanel
November 24, 2013
Overview: This training will introduce the chronology of the HACCP program in the US food industry, covering critical historical events and program developments. The 7 HACCP principles and elements thereof will be discussed to give trainees a comprehensive overview of HACCP. In order to round out th...
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214. The FDA Medical Device Pre-Submission Program and FDA Meetings - Webinar by GlobalCompliancePanel
November 24, 2013
Overview: The FDA Medical Device Pre-Submission Program is intended for companies to obtain FDA feedback on questions for future applications prior to their submission.
The submissions include Investigational Device Exemptions (IDE), Premarket Approval Application (PMA), Humanitarian Device...
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215. 2-day In-person Seminar on How to prepare and submit a Bullet Proof 510(k) and Latest FDA Proposed
November 07, 2013
Overview: This Two-day course is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed dev...
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216. 2-day In-person Seminar on why FDA at my Facility is, and what do I do During an Inspection at Los
November 07, 2013
Overview: 1. This course will teach you how to reduce software validation costs by as much as two thirds. 2. It details all the requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation. 3. The course is highly interactive, using real life example...
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217. 2-day In-person Seminar on Software Validation for the New FDA Inspections - Electronic Records and
November 07, 2013
Overview: 1. This course will teach you how to reduce software validation costs by as much as two thirds. 2. It details all the requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation. 3. The course is highly interactive, using real life example...
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218. Statistics for the Non-Statistician 2013
July 01, 2013
Statistics for the Non-Statistician Statistics for the non-statistician –doesn’t this appear oxymoronic? It does, but scratch the surface a bit, and you will find that like math and English, statistics is also meant for the layman. It is not statisticians alone that require statistics. It is meant...
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219. Complaint Handling, Medical Device Reporting and Recalls should be effective 2013
July 01, 2013
Complaint Handling, Medical Device Reporting and Recalls should be effective
Complaint handling is a critical aspect of a medical device manufacturing process. Once the product is out into the market after FDA approval and it still receives complaints, it is a sign that the device needs to b...
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220. Validating your own Excel Spreadsheet Application
May 21, 2013
Validating your own Excel Spreadsheet Application is important A key question many professionals face is: why should electronic records be validated? The answer is pretty straightforward: digitizing records is unavoidable, because organizations all over the world are moving towards electroni...
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GENE MYERS
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Author: John Robinson
