Product Quality/Safety

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Why is GRC important? blog
Submitted by nmarks on May, 17 2010

I have been blogging about what GRC is, advocating the definition developed by the Open Compliance and Ethics Group, OCEG (see this and subsequent posts). But, I haven’t really talked about why the concept of GRC has value.

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GRC in Chile - New Challenges blog

MIRAGroup Chile is in charge of development EGRC Concepts in multiples industries in this country. Our first purposes is help companies to understand this new way to manage Risk, Governance and Compliance as an integrated process.

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Cura Software Solutions Technology Provider

In today's fast paced global economy, with emerging threats, coupled with ever more regulations, organizations find themselves in a position that necessitates the active management of Governance, Risk, Opportunity, and Compliance. 

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Corporate Integrity LLC Advisory and/or Audit Firm

Integrity is a mirror revealing the truth about an individual or a corporation. It involves walking the talk -- not just talking it.

On a personal level, integrity is measured by what an individual does and does not do when no one is looking. Do they hold to their values, beliefs, and ethics? Or do they compromise and do the opposite of what they believe is right?

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EthicsPoint Technology Provider

EthicsPoint is the global leader in hotline and case management solutions.

EthicsPoint enables organizations to foster a business culture of integrity and compliance. We help our clients protect their culture and reputation by automating the business processes, from the reporting and identification of issues and events, to the subsequent investigation and resolution of behavior that may be inconsistent with their code of conduct.

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FDA, PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (2004) resource Agency Guidances OCEG Reviewed
This guidance is intended to describe a regulatory framework (Process Analytical Technology, PAT) that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance. Working with existing regulations, the Agency has developed an innovative approach for helping the pharmaceutical industry address anticipated technical and regulatory issues and questions.
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GAO, FDA's Oversight of the Promotion of Drugs for Off-Label Uses (2008) resource Research / Studies OCEG Reviewed
GAO was asked for information about the promotion of drugs for off-label uses. GAO reviewed (1) how FDA oversees the promotion of off-label uses of prescription drugs and (2) what actions have been taken to address off-label promotions. GAO examined documentation related to the promotion of drugs for off-label uses and FDA correspondence with drug companies on identified violations and obtained information from DOJ on relevant actions. GAO also interviewed officials at FDA and the HHS Office of Inspector General and representatives of national medical and pharmaceutical associations.
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Drugs for Human Use (21 C.F.R. Part 300 et seq.) resource National Regulations OCEG Reviewed
Subchapter D - Federal Regulations on Drugs for Human Use
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Drugs; General (21 C.F.R. Part 200 et. seq.) resource National Regulations OCEG Reviewed
Subchapter C - General Federal Regulations - Drugs
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