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- Live Webinars
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Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. Live Tuesday, February 7, 2012 10:00 AM PST | 01:00 PM EST, Duration:90 Minutes $245.00
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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 $245.00
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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 $245.00
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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 $245.00
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Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained
The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Live Tuesday, February 14, 2012 10:00 AM PST | 01:00 PM EST, Duration:60 Minutes $245.00
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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 $245.00
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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 $215.00
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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 $295.00
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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 $295.00
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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 $295.00
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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 $215.00
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Contract Manufacturing - it requires more than you think to do it right Overseeing your contract manufacturer is a skill that is better learnt before you make a single dose rather than on the job. Recorded Wednesday, April 28, 2010 10:00 AM PST | 01:00 PM EST, Duration:60 Minutes $295.00
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