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Pharmaceutical Compliance Training & Best Practices
Get trained on Regulations and compliance processes for pharmaceutical companies. This section constitutes of Pharma Compliance training delivered by compliance experts, standards, checklists, best practices and news.
Featured Trainings
Compliance Trainings in Oct.
 
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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Key Factors to Write an Effective Standard Operating Procedure (SOP)

Instructor : Kim Huynh-Ba Live Thursday, September 9, 2010 | 10:00 AM PDT | 01:00 PM EDT

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The role of Analytical Program to Support Drug Development Process

Instructor : Kim Huynh-Ba Live Tuesday, September 14, 2010 | 10:00 AM PDT | 01:00 PM EDT

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Stability Program to support Shipping and Distribution of Drug Products

Instructor : Kim Huynh-Ba Live Wednesday, September 22, 2010 | 10:00 AM PDT | 01:00 PM EDT

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The Hero of Manufacturing Contamination Control -- The Microbiology Lab

Instructor : T.C Soli Live Wednesday, September 22, 2010 | 10:00AM PDT | 1:00PM EDT

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Out-of-Specification Investigations – Beyond the laboratory

Instructor : John G Lanese On Demand Access Anytime

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Clinical Trial auditing - Identifying risks and building a more compliant and successful trial

Instructor : Peter Calcott 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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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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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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Importance of Method Validation Protocols and components of MVP in the Laboratory

Instructor : Brian Jones Live Friday, October 15, 2010 | 10:00 AM PDT | 01:00 PM EDT

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Preparing for and handling FDA Laboratory GMP inspections

Instructor : Nanda Subbarao Live Friday, October 15, 2010 | 10:00 AM PDT | 01:00 PM EDT

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The Tougher U.S. FDA - One Year Later

Instructor : John E Lincoln Live Tuesday, October 19, 2010 | 10:00 AM PDT | 01:00 PM 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
SEP Safety Series - Chemical Shipping & Receiving
Price: $10
Laboratory Procedure for GC Analysis of Alcohol
Price: $27
Laboratory Manual
Price: $97
Laboratory Procedure for Determining Hydroxide and Carbonate in KOH
Price: $67
More Standards...
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