151. Mastering the HIPAA Privacy, Security, and Breach Notification Rules: Coping with Rule Changes, Man
February 25, 2014
Summary:
GlobalCompliancePanel will hold a two-day, in-person seminar in Phoenix, AZ on the topic, “Mastering the HIPAA Privacy, Security, and Breach Notification Rules: Coping with Rule Changes, Managing Incidents, Preparing for Audits, and Avoiding Penalties” on March 17th and 18th, 2014 ...
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152. Effective Complaint Handling, Medical Device Reporting and Recalls
February 25, 2014
Summary:
GlobalCompliancePanel will organize a RAPS-approved two-day, in-person seminar in Phoenix, AZ on the topic, “Effective Complaint Handling, Medical Device Reporting and Recalls” on February 27 and 28, 2014 (Thursday & Friday). David Dills, a well-known independent Regulatory & Compl...
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153. Computer System Validation -Reduce Costs and Avoid 483s
February 25, 2014
Summary:
GlobalCompliancePanel will organize a RAPS-preapproved two-day, in-person seminar in Chicago, IL on the topic, “Computer System Validation –Reduce Costs and Avoid 483s” on February 6 and 7, 2014 (Thursday & Friday). Angela Bazigos, CEO of Touchstone Technologies Silicon Valley, Inc...
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154. Clinical Trial Applications in Canada, and Comparison to US and EU
February 25, 2014
Summary:
Seminar “Clinical Trial Applications in Canada, and Comparison to US and EU” explains the working of Health Canada’s clinical trials and drug development in all their details.
Venue, date and timings:
Anne Tomalin, President of Therapeutic Products Inc., will be th...
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155. Statistics for the Non-Statistician
February 25, 2014
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...
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156. Complaint Handling, Medical Device Reporting and Recalls should be effective
February 25, 2014
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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157. Computer systems validation (CSV) need to avoid 483's/Warning Letters
February 25, 2014
Those in computer systems validation (CSV) need to avoid 483’s/Warning Letters
One of the prime requirements for those in CSV, also known as Software Validation, apart from coming out with quality output, is avoiding 483’s/Warning Letters from the FDA. Computer Systems Validation (CSV) bein...
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158. Acceptance Sampling - Methods and ApplicationsAcceptance Sampling - Methods and Applications
February 25, 2014
Summary: GlobalCompliancePanel to hold RAPS-approved, two-day, in-person seminar in Boston, MA on the topic, “Acceptance Sampling – Methods and Applications” on March 6 and 7, 2014 (Thursday & Friday). Dan OLeary, President of Ombu Enterprises will be the speaker at this two-day session. T...
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159. 2-day In-person Seminar on Computer System Validation - Reduce Costs and Avoid 483s at Los Angeles
January 28, 2014
Overview:
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 how to...
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160. 2-day In-person Seminar on Clinical Trial Applications in Canada, and Comparison to US and EU at To
January 28, 2014
Overview:
This seminar will cover the organization of Health Canada as it relates to clinical trials and drug development, Canadian regulations governing the conduct of clinical trials in this country, the process for getting approval of clinical trials, requirements after approval of the tr...
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