ComplianceOnline articles
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When the internet was not as ubiquitous as it is today, Life Sciences Companies maintained documents manually. Submitting truckloads of paper records to the FDA was a norm when the U.S. Food and Drug Administration (FDA) issued 21 CFR Part 11 back in 1997.
With the evolution of the internet, more companies joined the inevitable movement toward the use of electronic systems. This article is a ready reckoner for Companies that are looking to buy COTS (
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9 Statistics on 2017 EEOC Claims
On January 25, 2018 the U.S. Equal Employment Opportunity Commission (EEOC) announced that a decreased number (from 2016) of 84,254 workplace discrimination charges were filed with the federal agency during the fiscal year of 2017. These charges, lawsuits and settlements, secured $398 million for victims in private sector, state and local government workplaces, costing organizations and tax payers a significant amount
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While both ICH Q3D and USP General Chaptersandare scheduled to go into effect in 2018, implementation requires extensive prior work. The new elemental impurities limits require more sophisticated analytical technology, such as ICP-MS, not routinely used in QC labs. The ultra-sensitive analytical method must be validated specifically for all of your different dosage forms.
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FMLA is a growing concern for employers. Confusing regulations, along with numerous changes to the FMLA law, as well as, conflicting court decisions, cause FMLA to be one of the biggest compliance challenges for employers. Since the FMLA legislation was passed in the mid-1990, case law and changes have expanded the definition of Family and Medical Leave. States and cities are now enacting paid leave laws, with New York moving forward with paid leave in 2018.
Matthew Burr
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The Reason Supply Chain Responsibility is a Must
Supply chain management – a term coined in the early ‘80s when globalization and outsourcing spread their wings to seek offshore hubs to reduce costs, and source labor and materials closer to their operational and production setups in emerging economies. While supply chain management found its definitions and parameters, the need for supply chain responsibility came quick a
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The U.S. FDA has recently released two Food Safety Modernization Act (FSMA) compliance guidance documents to aid small businesses with the implementation of the Preventive Controls for Human Food and Preventive Contro
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A draft guidance, published by the State Council`s Legislative Affairs Office, is soliciting public opinion for revising and regulating China’s online food sales. The draft regulation calls for stringent liabilities and rules for food producers and operators of online sales platforms. It also states that
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Corruption at a major sporting event takes away something from the integrity of the game. On an organizational front, corruption takes away from business integrity too. Consequently, committees have been set up, stringent laws have been enforced, and staggering penalties have been levied – but has the lesson hit home?
The laws that champion the cause are many, but here’s a look at a few global game changers.
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The Monetary Authority of Singapore’s Risk Management Practices Guidelines dealing with internal controls makes it clear that a financial institution’s Board and senior management must establish processes, policies and procedures ensure its compliance with regulatory requirements. These policies and processes should also make sure that the institution’s operations are effective and compliant.
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New Zealand established these risk management program requirements for non-bank deposit takers under 157M of the Reserve Bank Act 1989. This article gives an overview and summary of its key requirements.