Safety Critical Software - Software Risk Management Using IEC62304 as the internationally recognized software lifecycle standard the risk dependent activities and documentation requirements will be explained. Live
Tuesday,
February 7, 2012
10:00 AM PST | 01:00 PM EST,
Duration:60 Minutes
Product Risk Management Under ISO 14971 and FDA-ICH Q9 Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies. Live
Wednesday,
February 8, 2012
10:00 AM PST | 01:00 PM EST ,
Duration:90 Minutes
Supply Chain Risk Management For the last decade, there has been an extensive and organized effort by organizations to assess their risks, especially in financial services. Non Financial firms are now increasing their risk management especially in the light of such complex, global, and out sourced supply chains. The new ISO 31000 and ISO 31010 frameworks provide guidelines in this process that make good sense and build on years of work by risk professionals. Live
Thursday,
February 9, 2012
10:00 AM PST | 01:00 PM EST,
Duration:90 Minutes
FDA's 21 CFR 11 Add-On Inspections - Recent Updates This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome. Live
Tuesday,
February 14, 2012
10:00 AM PST | 01:00 PM EST,
Duration:90 Minutes
PCI DSS: Tips and Trends for 2010 Compliance to the PCI DSS can be an overwhelming task in the beginning. The requirements are specific and if your organization has not had an information security program in place, there may be a lot to do to meet minimum compliance requirements. Recorded
Thursday,
May 13, 2010
11:00 AM PST | 02:00 PM EST,
Duration:60 Minutes
Management Review: The Complete Requirements One of the main elements to a fully implemented Quality Management System (QMS) is the Management Review. Recorded
Thursday,
May 13, 2010
11:00 AM PST | 02:00 PM EST,
Duration:60 Minutes
Statistical Process Control and Trending Analysis There are several methods to trend data to highlight both the preventative and corrective nature of the system. Recorded
Tuesday,
May 11, 2010
10:00 AM PST | 01:00 PM EST,
Duration:60 Minutes
Development and Audit of Complaint Handling and MDR Processes Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. Recorded
Thursday,
May 6, 2010
10:00 AM PST | 01:00 PM EST,
Duration:60 Minutes
Webinar on Allergen control Allergens under regulatory control are limited to 8. However, they take on many names and forms. Identifying and avoiding these allergens are an important strategy for manufacturers as well as consumers. Recorded
Thursday,
April 29, 2010
10:00 AM PST | 01:00 PM EST,
Duration:60 Minutes