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Regulatory Compliance training, Standards, Best Practices & News
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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Compliance Trainings in Jun.
 
Best Practices for Maintaining an IND and IDE Application with FDA

Instructor : Mukesh Kumar Live Wednesday, May 16, 2012 | 10:00 AM PDT | 01:00 PM EDT

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Designing Medical Device Alarms to Mitigate New FDA Concerns

Instructor : Dev Raheja Live Wednesday, May 16, 2012 | 10:00 AM PDT | 01:00 PM EDT

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Why and How - Verification of Compendial Methods - USP <1226>

Instructor : Nanda Subbarao Live Wednesday, May 16, 2012 | 10:00 AM PDT | 01:00 PM EDT

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Cosmetics – How Are they Regulated?

Instructor : Susan Augello-Vaisey Live Wednesday, May 16, 2012 | 10:00 AM PDT | 01:00 PM EDT

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Analytical Test Methods Validation: FDA, ICH and USP Requirements

Instructor : Richard Poser(PhD) Live Thursday, May 17, 2012 | 10:00 AM PDT | 01:00 PM EDT

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Basic and Meaningful Human Resource Metrics

Instructor : Marna Hayden Live Thursday, May 17, 2012 | 10:00 AM PDT | 01:00 PM EDT

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Food Safety Traceability Systems: Identifying, Locating and Knowing the Condition of Food in the Supply Chain

Instructor : Dr. John Ryan Live Thursday, May 17, 2012 | 10:00 AM PDT | 01:00 PM EDT

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Device Corrections and Removals

Instructor : Daniel O Leary Live Friday, June 1, 2012 | 08:00 AM PDT | 11:00 AM EDT

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Service Level Agreements (SLAs) - Preparation Guidelines for Effective SLAs

Instructor : Javier Kuong Live Monday, June 4, 2012 | 09:00 AM PDT | 12:00 PM EDT

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ICH Q10; moving from GMPs to a Pharmaceutical Quality System

Instructor : John G Lanese Live Tuesday, June 5, 2012 | 10:00 AM PDT | 01:00 PM EDT

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The 21 Elements of a 510(k)

Instructor : John E Lincoln Live Tuesday, June 5, 2012 | 10:00 AM PDT | 01:00 PM EDT

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Verification and Validation (V&V) of Software in the Medical Devices

Instructor : Dev Raheja Live Wednesday, June 6, 2012 | 10:00 AM PDT | 01:00 PM EDT

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Unsolicited Drug and Device Off-Label Claims Via Social Media and Risk Management

Instructor : Charles R. McConachie Live Wednesday, June 6, 2012 | 10:00 AM PDT | 01:00 PM EDT

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CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment

Instructor : Barry Craig Live Thursday, June 7, 2012 | 10:00 AM PDT | 01:00 PM EDT

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Article of this Week
Why Did the SEC Charge Medical Device Company Biomet with Foreign Bribery?

According to the Securities and Exchange Commission (SEC), Biomet Inc violated the provisions of the Foreign Corrupt Practices Act (FCPA). The violation occurred in the form of bribes that Biomet’s subsidiaries and their agents paid to public doctors in Argentina, Brazil and China for almost a decade in order to bag business.

This article details the allegations against Biomet and the compliance best practices that have to be followed to avoid similar charges.

Read Complete Article...
Compliance Best Practices
Biotechnology
Best Practices to Comply with Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products
Best Practices to Comply with Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products
more...
Clinical Compliance
Adverse Event Reporting to IRBs – Best Practices to Follow
The Role and Responsibilities of Ethics Committees in Clinical Research: What are the Best Practices?
more...
Corporate Governance
Why Did the SEC Charge Medical Device Company Biomet with Foreign Bribery?
Olympus Accounting Fraud - How Could It Have been Prevented and Lessons Learned
more...
EH&S Green Compliance
OSHA’s New GHS Chemical Labeling Requirements – What Are Recommended Compliance Best Practices?
What were the EPA’s Top Enforcement Actions in 2011? How Can Industries Ensure Compliance in 2012?
more...
Energy and Utility
How Does OSHA’s New National Emphasis Program (NEP) Improve on the 2009 Pilot Program? How can Chemical Facilities Ensure Compliance?
more...
FDA Compliance
Management Responsibility for Integrating Medical Device Design
What are the GMP Compliance Issues Faced by Dietary Supplement Manufacturers?
more...
FDA 510k program
Compliance News
The World's Most Ethical Companies...
... business practices; looking at activities designed to...
Consultancy for Improvement...
... key equipment failure and field returns. 6.4 Work...
Medical & Radiation Emitting...
HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2...
Food Safety News - Iowa State...
SUMMARY: In accordance with the Paperwork Reduction Act of 1995...
More News...
Compliance Standards
Evidence Product Checklist For Standard IEC 62304:2006 “Medical Device Software – Software Life Cycle Processes”
Price: $299
(New) Template Kit for Software Engineers
Price: $598
Evidence Product Checklist For Standard ISO/IEC 20000-1:2011 “Information Technology –Service Management –Part 1: Service Management System Requirements”
Price: $299
Quality Kit
Price: $748
More Standards...
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