is being presented by John English, Principal, John T. English Regulatory Consulting and airs on Thursday, Novemeber 11th, 2010. For more details or to register, please visit our site at www.fxconferences.com
When 21 CFR Part 11 was published over 15 years ago, it was supposed to be a positive development. The FDA was giving companies a way to save on paper – and time and money – by opening a pathway to using “Electronic Records and Electronic Signatures.” It was supposed to recognize technical developments that were having an impact on the regulated industries.
It has been over five years since an update to Part 11 was promised. At this point, what is definitely coming are “tag-along inspections” to measure the state of industry compliance and to benchmark where companies stand in terms of compliance. CDER, the center driving this, has indicated that the results may lead to an updated approach to Part 11 compliance, a re-work of the regulation and/or regulatory citations for the companies involved.
Showing posts with label John T. English Regulatory Consulting. Show all posts
Showing posts with label John T. English Regulatory Consulting. Show all posts
Wednesday, October 13, 2010
Wednesday, June 16, 2010
Cloud Computing for the FDA-Regulated Company
is being presented by John English, Principal, John T. English Regulatory Consulting and airs on Thursday, July 15th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Your inbox and the media are both full of offerings and commentary on cloud computing. What exactly is it? Why are IT and finance people so bullish on it? Are there regulatory implications to embracing this strategy?
This presentation looks at the technical aspects of the 'cloud' paradigm in terms appropriate for the non-IT professional. The speaker uses this information, along with current examples from industry, to explain the fiscal and technical advantages that are driving many companies to explore and/or adopt this approach. The presentation also reviews and analyzes some basic issues an FDA-regulated company must understand and take into account before jumping on the cloud computing bandwagon.
Your inbox and the media are both full of offerings and commentary on cloud computing. What exactly is it? Why are IT and finance people so bullish on it? Are there regulatory implications to embracing this strategy?
This presentation looks at the technical aspects of the 'cloud' paradigm in terms appropriate for the non-IT professional. The speaker uses this information, along with current examples from industry, to explain the fiscal and technical advantages that are driving many companies to explore and/or adopt this approach. The presentation also reviews and analyzes some basic issues an FDA-regulated company must understand and take into account before jumping on the cloud computing bandwagon.
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