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FAA Regulations Training & Best Practices
Get trained on FAA regulation based trainings, learn the best practices and download quality standards, checklists and news articles. Listen to experts on best practices to streamline quality and compliance processes and meet the regulatory demands.
Featured Trainings
Compliance Trainings in Oct.
 
ISO 9001:2000 1st, 2nd and 3rd Party Auditing & Implementation

Instructor : Mark Stevens On Demand Access Anytime

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How to Design an Effective and Efficient ISO 9001:2000 Management Review Process

Instructor : Michael A Mathe On Demand Access Anytime

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Aerospace -Transitioning to AS9100 Rev.C

Instructor : Rick Saldivar On Demand Access Anytime

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How to Internal Audit to ISO 9001:2008

Instructor : Rick Saldivar On Demand Access Anytime

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Aerospace - transitioning to AS9100 Rev.C – Effect of Addition of Risk Management requirements

Instructor : Rick Saldivar On Demand Access Anytime

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GMPs in Biopharmaceutical Development Laboratories

Instructor : Nanda Subbarao Live Friday, October 1, 2010 | 10:00 AM PDT | 01:00 PM EDT

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The FDA Tripod - Clinical Trial Regulations, Compliance and GCP in Drug Development

Instructor : Sandy Rizk Soliman Live Tuesday, October 5, 2010 | 10:00 AM PDT | 01:00 PM EDT

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Best Practices on Financing Renewable Energy and Energy Efficiency Initiatives

Instructor : Federico Fische Live Tuesday, October 5, 2010 | 10:00 AM PDT | 01:00 PM EDT

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Project Management for FDA-Regulated Companies

Instructor : John E Lincoln Live Tuesday, October 5, 2010 | 10:00 AM PDT | 01:00 PM EDT

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Best Practices for Writing an Effective SOP to Lead to Successful FDA Inspections

Instructor : Glen Feye Live Thursday, October 7, 2010 | 10:00 AM PDT | 01:00 PM EDT

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Study of NAIC (National Association of Insurance Commissioners) Model Regulation - Banking and Financial Services

Instructor : Kenneth Barden Live Thursday, October 7, 2010 | 10:00 AM PDT | 01:00 PM EDT

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Integrating Clinical Evaluation and Risk Management (ISO 14971)

Instructor : Daniel O Leary Live Thursday, October 7, 2010 | 08:00 AM PDT | 11:00 AM EDT

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Article of this Week
How to purchase COTS software

Software has become part of almost every business process and the scope and complexity of software is increasing every year. Most software is purchased from a vendor and is referred to as commercial off-the-shelf software (COTS). The term “developer” identifies people that create software and for the purposes of this article is equivalent to the vendor. The term “user” identifies people that use software to perform their job.

The developer and users share responsibilities that affect the quality of the software. The developer must create the software to contain the functionality required by the users, and perform developer validation. The users must perform user validation of the software in the context of its application, meaning the business processes that use the software.  Additionally, the user must ensure proper maintenance and control of the software on an ongoing basis.

The requirements of validation from the developer and user perspectives have many steps in common but the focus of each step is different because their perspectives are different. 

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Compliance Standards
Validation Master Plan
Price: $90
Method Validation
Price: $79
QVD Protocol and Report Preparation
Price: $99
Monitoring of Clinical Trials
Price: $29
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