Abstract: There`s a lot of buzz around HCCs in the healthcare. But not everyone understands why and how to use them. Coding and auditing errors can have a negative impact on the organization’s revenue cycle. Hospital and clinical staff, ...
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 ...
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 ...
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, ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Abstract: Elemental impurities have been topic of discussion since 2009 when the ICH commenced work to provide an international standard to limit the impurities in drug products and ingredients. FDA too has released its guidance on the control of ...
Abstract: DHS Issues Guidance on HIPAA and Cloud Computing Cloud computing, an indelible part of healthcare systems and networks today, will now be regulated and brought under the HIPAA fold. DHS released the guidance that details the requirements ...
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 ...
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 ...
Abstract: What`s Safe in Your Medicine Cabinet: Dietary Supplements in the U.S. From regulating hormone levels to supplementing nutritional deficiencies in children, dietary supplements have a broad spectrum of needs to cater to. Popping a vitamin ...
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 ...
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
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 ...
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 ...
Abstract: An original drug manufacturer seeking new drug approval from the FDA is responsible for accurately and adequately labeling the new drug. A manufacturer of a generic drug is only responsible for making sure its warning label is the same as ...