17 Articles found
ComplianceOnline Articles
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Guide to buying COTS software - How to audit and evaluate vendors
Abstract: 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 ...
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Grievances and complaints - An overview of the CMS, Joint Commission, DNV and OCR Standards Hospitals should know about
Abstract: No hospital wants to receive a statement of deficiencies and plan of correction from the regulatory bodies. Non-compliance with the grievance requirements is the third most problematic area that invites investigation. What if a CMS ...
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Receipt and storage of cGMP controlled raw materials regulations and best practices
Abstract: Receipt and Storage of cGMP Controlled Raw Materials Regulations and Best Practices Manufactures of drugs who lack a defined raw material processing have received FDA 483s and lost several batches of products. Designing the Receipt, ...
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9 statistics on 2017 EEOC claims
Abstract: 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 ...
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ICH Q3D elemental impurity guidelines: Are you prepared for January 2018?
Abstract: 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 ...
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11 FMLA mistakes employers make
Abstract: 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 ...
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The reason supply chain responsibility is a must
Abstract: 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 ...
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FDA issues FSMA preventive controls guidance for small businesses
Abstract: 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 Controls for Animal ...
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Beyond Basel iii: What does Basel IV promise?
Abstract: Credit risk, market risk, operational risk, counterparty credit risk, interest rate risk, and capital floors – a list of things on the itinerary for Basel IV. While yet adjusting to the requirements of Basel III, the newer ...
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China: Food safety draft requires stringent online regulations
Abstract: 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 ...
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FCPA, UK Bribery Act, Brazilian Clean Company Act - The Olympians of Corruption
Abstract: 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 ...
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Monetary authority of Singapore risk management practices guidelines – Internal Controls: Overview and summary of requirements
Abstract: 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 ...
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Risk management guidelines for New Zealand non-bank deposit takers – Overview and summary of requirements
Abstract: 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. Click here for detail description
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ISO 22301-2012: Setting up and managing business continuity management systems – Overview and summary
Abstract: ISO 22301 is an international ISO standard that specifies requirements for the setting up of and management of an effective Business Continuity Management System (BCMS). This article discusses the applicability of the standard, the model ...
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FDA challenges dietary supplement makers on marketing of DMAA products
Abstract: The FDA, which regulates dietary supplement products and their ingredients, recently warned manufacturers of dietary supplements containing DMAA (1, 3-dimethylamylamine) for not providing evidence regarding safety of their products. The ...
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Factors to be considered in bio-similar product development – Overview of FDA draft guidance
Abstract: On February 9, 2012, the U.S FDA released draft guidelines about scientific and quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity ...
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EBA guidelines on internal governance – Overview and summary of requirements
Abstract: The European Banking Authority (EBA) has published its new Guidelines on Internal Governance. These aim at enhancing and consolidating supervisory expectations and improving the implementation of internal governance arrangements for ...