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| Articles by John Robinson |
171. 2-day In-person seminar on Regulatory Compliance for Dietary Supplements in the US, EU and Canada a
January 08, 2014
Overview:
The course will cover basic regulatory requirements for marketing of dietary supplements in the U.S. and Canada including product safety, manufacturing, product claims, and labelling requirements. A general overview of EU regulations will also be given.
Why you should atten...
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172. 2-day In-person seminar on The A to Z's of Microbial Control, Monitoring, Validation and Troublesho
January 08, 2014
Overview:
This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this...
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173. 2-day In-person seminar on Computer System Validation - Reduce Costs and Avoid 483s At Chicago IL
January 08, 2014
Overview: 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. The latter impact all areas of ICH Q9 and ICH Q10. However, unless one knows...
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174. 2-day In-person seminar on The A to Z's of Microbial Control, Monitoring, Validation and Troublesho
January 08, 2014
Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this traini...
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175. 2-day In-person Seminar on Why is FDA at my Facility, and What do I do During an Inspection at Sing
January 08, 2014
Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a C...
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176. 2-day In-person seminar on The A to Z's of Microbial Control, Monitoring, Validation and Troublesho
January 08, 2014
Overview:
This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this...
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177. 2-day In-person Seminar on Why is FDA at my Facility, and What do I do During an Inspection at Duba
January 08, 2014
Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a C...
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178. How to Manage a Medical Device Recall Efficiently and Effectively - Webinar by GlobalCompliancePane
December 04, 2013
Overview: This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.
Recall means the correction or removal of a ...
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179. CAPA Challenges and FDA Expectations - Webinar by GlobalCompliancePanel
December 04, 2013
Overview: CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
A compliant CAPA system is required to "close-t...
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180. FDA's New Breakthrough Therapy Designation Program and Other FDA Expedited Programs - Webinar by Gl
December 04, 2013
Overview: This webinar will discuss four FDA expedited programs intended to facilitate and expedite development, review and approval of new drugs to address unmet medical needs in the treatment of serious and life-threatening conditions. This webinar includes FDA's newest expedited program Breakthro...
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Author: John Robinson
