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Regulatory Compliance training, Standards, Best Practices & News |
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| Get trained on regulations affecting your industry through online webinars, 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. |
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The Riskability Roadmap - Building the EGRCM Plan & Implementation Challenges
Instructor : Kersi Porbunderwalla
Live Tuesday, September 7, 2010 | 08:00 AM PDT | 11:00 AM EDT
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How to conduct a software risk assessment that is meaningful
Instructor : David Nettleton
Live Tuesday, September 7, 2010 | 10:00 AM PDT | 01:00 PM EDT
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How do I keep FDA happy with my contract manufacturer?
Instructor : Dennis Moore
Live Wednesday, September 8, 2010 | 10:00AM PDT | 1:00PM EDT
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Engineering and Laboratory Mythology with Water System
Instructor : T.C Soli
Live Wednesday, September 8, 2010 | 10:00AM PDT | 1:00PM EDT
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Immunogenicity to biologics: processes, impact on efficacy and safety, and management strategy
Instructor : Chitra Edwin
Live Wednesday, September 8, 2010 | 10:00 AM PDT | 01:00 PM EDT
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Controlling Change to meet GMP Requirements
Instructor : John E Lincoln
Live Thursday, September 9, 2010 | 10:00 AM PDT | 01:00 PM EDT
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How to conduct Risk Assessments as per ISO 31000/31010(SOX)
Instructor : Kenneth Barden
Live Thursday, September 9, 2010 | 10:00 AM PDT | 01:00 PM EDT
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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 |
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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 Best Practices |
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Compliance News |
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