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Biotech Regulatory Compliance Training & Best Practices
Learn Biotech industry, compliance best practices through expert training/ webinar programs to streamline the compliance processes. This section constitutes biotech regulation based trainings, regulatory standards, best practices and news.
Featured Trainings
Compliance Trainings in Oct.
 
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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Risk Assessments - Key to a Viral Safety Management Plan

Instructor : Kathryn Martin Remington Live Wednesday, September 15, 2010 | 10:00 AM PDT | 01:00 PM EDT

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How to Investigate Water System Contamination with Example Case Studies

Instructor : T.C Soli Live Thursday, October 14, 2010 | 10:00AM PDT | 1:00PM EDT

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cGMP: Strategies for implementation and compliance for Phase I Investigational Drug and Biologic products

Instructor : Chitra Edwin On Demand Access Anytime

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Understanding the new FDA Guidance for Immunogenicity Testing

Instructor : Ana Menendez On Demand Access Anytime

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Understanding Disinfectant Qualification Studies – How to avoid errors

Instructor : Ziva Abraham On Demand Access Anytime

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Environmental Monitoring and the Contamination Control Plan

Instructor : Scott Sutton On Demand Access Anytime

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How to Investigate Water System Contamination with Example Case Studies

Instructor : T.C Soli Live Thursday, October 14, 2010 | 10:00AM PDT | 1:00PM EDT

View Details >

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Subscribe to Compliance Training Alerts
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 Best Practices
Biotechnology
USDA biotech regulations on “Pharma” crops allow drugs in food
Biotechnology Regulation in India – Progress so-far
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Compliance News
On The Front Line In China:...
... What’s the environment in China like for whistle-blowers? Yang: In China, it is difficult to be ... a...
What is ISO 14000 (International...
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Food Safety News - Iowa State...
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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
More Standards...
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