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Excel Spreadsheet Validation To Eliminate 483s
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.
Live
Wednesday,
March 10, 2010
11:00 AM PST | 02:00 PM EST,
Duration:75 Minutes
$245.00
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Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems
Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive.
Live
Thursday,
March 11, 2010
10:00 AM PST | 01:00 PM EST,
Duration:90 Minutes
$245.00
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New Requirements for the Medical Device Directive (MDD)
Back 0n September 5th 2007 the European Union released directive 2007/47/EC (amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market).
Live
Thursday,
March 11, 2010
11:00 AM PST | 02:00 PM EST,
Duration:60 Minutes
$245.00
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Quality Systems Inspection Technique (QSIT), and How to use it to Your Advantage
Virtually all field inspections performed by FDA inspectors are done according to the QSIT.
Live
Thursday,
March 11, 2010
10:00 AM PST | 01:00 PM EST,
Duration:60 Minutes
$245.00
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...more
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Risk Management during device design according to ISO14971
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The presentation provides practical tips to comply with ISO14971, implement risk management, and minimize the administrative burdens imposed to handle the additional process.
Live
Tuesday,
September 15, 2009
09:00 AM PDT | 12:00 PM EDT,
Duration:60 Minutes
$245.00
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Changes and the 510(k)
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The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Live
Tuesday,
August 11, 2009
09:00 AM PDT | 12:00 PM EDT,
Duration:60 Minutes
$245.00
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Water System Biofilm Control and Microbial Monitoring Myths
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It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Live
Thursday,
December 3, 2009
09:00 AM PST | 12:00 PM EST,
Duration:90 Minutes
$245.00
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Complaint Handling in Compliance with FDA and ISO Regulations
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Negative customer feedback about a product’s performance or safety is a strong indicator of whether a firm's manufacturing process is in control.
Live
Thursday,
July 23, 2009
10:00 AM PDT | 01:00 PM EDT,
Duration:60 Minutes
$245.00
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...more
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Call: 800-447-9407 
Fax: 302-288-6884
