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| Articles by John Robinson |
71. 2-day In-person seminar on Quality System Regulations for Drugs, Devices, and Tablets and How to ge
August 18, 2014
Overview:
Primary Student Objectives - General High Level Topics where we will move down to very specific discussion and details to generate a much higher comprehension for quality individuals even though during this course you will not have to take a final exam! Upon completing this course...
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72. 2-day In-person seminar on Effective Complaint Handling, Medical Device Reporting and Recalls and A
August 18, 2014
Overview:
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Th...
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73. 2-day In-person seminar on Effective Complaint Handling, Medical Device Reporting and Recalls and A
August 18, 2014
Overview: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Th...
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74. 2-day In-person Seminar on "GMP Compliance for Pharmaceutical Quality Control Laboratories" in Berl
July 27, 2014
Overview:
This course is designed for people who are growing in their knowledge of pharmaceutical quality control practices and regulations. It will be a "how to" course where the instructor will explain the reasoning as well as the procedures that should be used to meet the various requirem...
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75. GMP Compliance for Pharmaceutical Quality Control Laboratories: 2-day In-person Seminar
July 27, 2014
Overview:
This course is designed for people who are growing in their knowledge of pharmaceutical quality control practices and regulations. It will be a "how to" course where the instructor will explain the reasoning as well as the procedures that should be used to meet the various requirem...
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76. 2-day In-person Seminar on Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems a
July 27, 2014
The Problem:
Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect ...
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77. 2-day In-person Seminar on "GMP Compliance for Pharmaceutical Quality Control Laboratories" in Melb
July 27, 2014
Overview:
This course is designed for people who are growing in their knowledge of pharmaceutical quality control practices and regulations. It will be a "how to" course where the instructor will explain the reasoning as well as the procedures that should be used to meet the various requirem...
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78. Live Seminar: Advertising and Promotional Requirements for Drugs and Medical Devices by David R. D
July 27, 2014
Overview:
The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration ("FDA"). How the FDA will deal with such advanced communication technology that can g...
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79. 2-day In-person Seminar on Global Medical Device Regulation: US, EU and Canada at Chicago IL
July 27, 2014
Overview:
This course provides an overview of international medical device regulations. Beginning with a discussion of the similarity of global requirements, including both voluntary and mandatory standards and directives, and progressing to in-depth analyses of market specific requirements,...
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80. How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
July 01, 2014
Overview:
During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with...
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A postgraduate in Fashion Technology. Shalini is a writer at heart! Writing for her is an expression...more
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Author: John Robinson
