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Regulatory Affairs Professional,

John E Lincoln
Consultant, Medical device and Regulatory affairs,

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Founder & Principal, GXP Biotechnology, LLC
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Practical Water System Design and Operation Issues Impacting Biofilm Control
Most people who design, maintain, and monitor high purity water systems have heard of biofilm and a few "rules" about how to control and monitor it.
Live  Thursday, February 11, 2010 10:00 AM PST | 01:00 PM EST,  Duration:90 Minutes
$245.00

21 CFR Part 11: Auditing for Part 11 Compliance
21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries.
Live  Thursday, February 11, 2010 11:00 AM PST | 02:00 PM EST,  Duration:75 Minutes
$245.00

Risk Management in IEC 60601-1 Third Edition
IEC 60601-1 Third Edition was released in late 2005. It is a new philosophy in standards for medical electrical devices to accommodate rapid advances in technology.
Live  Tuesday, February 16, 2010 11:00 AM PST | 02:00 PM EST,  Duration:90 Minutes
$245.00

Water Microbial Test Methods: Harmonization vs Optimal Quality Control – Your Choice
As much compendial test method harmonization as has already occurred with Microbial Limits testing for non-sterile products and raw materials, surprisingly little has occurred with the microbial test methods used for testing water.
Live  Thursday, February 25, 2010 10:00 AM PST | 01:00 PM EST,  Duration:90 Minutes
$245.00

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