SAS Institute, Inc. Technology Provider
Deloitte Advisory and/or Audit Firm
Corporate Integrity LLC Advisory and/or Audit Firm
Cura Software Solutions Technology Provider
Mitratech Technology Provider
Why is GRC important? blog
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.
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.
Prescription Drug Marketing Act (PDMA) - Relevant Laws and Legislative History resource National Laws OCEG Reviewed
The Prescription Drug Marketing Act of 1987 (PDMA) was signed into law by the President April 12, 1988. The PDMA was enacted (1) to ensure that drug products purchased by consumers are safe and effective, and (2) to avoid the unacceptable risk to American consumers from counterfeit, adulterated, misbranded, subpotent, or expired drugs. The legislation was necessary to increase safeguards in the drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs.
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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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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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