All Blog Posts (1,471)

Carrying out audits is among the most important requirements for any organization that handles Protected Health Information (PHI). HIPAA hosting providers, who implement safeguards in the manner specified in the HIPAA Privacy Rule, must be included in these audits. The indispensability of audits to…

Aseptic technique is one of the methods used in eliminating or at least minimizing contamination in pathogens. It is also used to make compounding sterile products. Sterilized equipment, sterile apparel, high degree of processing, and cleaning on a continuous basis make up the important procedures used in aseptic technique.

The main aim of aseptic technique in cleanrooms is to ensure that the sterile product is sterile, safe and effective. Ensuring this is all the more important for…

The North American Free Trade Agreement (NAFTA) came into being on the first day of 1994. While the US and Canada had been having free trade agreements that go back at least three decades culminating in the US-Canada Free Trade Agreement of January 1, 1989; NAFTA became a reality following Canada’s entry in 1991 into the bilateral talks between the US and Mexico, creating the trilateral FTA.

One of the primary objectives of the NAFTA was the elimination of a number of duties and…

Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971.

You’ll learn techniques that can help you identify hazards and potential harms. You’ll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products. A rigorous…

Stark Law compliance is now more than just a compliance issue. It has grown to become an Enterprise Risk Management matter, if the substantial awards and settlements in recent enforcement actions are anything to go by. For healthcare organizations that develop and implement provider contracts; managing their compliance and enterprise risk by ensuring that…

The credit card surcharge issue has always been a tricky one in the US. Back in 2005, this issue was the subject of an antitrust lawsuit, and the resultant judgment, which came in mid-2012 prohibited credit card surcharge in ten States. Another 12 States are in the process of implementing their laws.

Although credit card regulations have traditionally opposed surcharging; companies have been circumventing merchant rules to ensure that credit card surcharge continues to be made. Even…

Good Laboratory Practices (GLP’s) are a series of federal regulations passed in the US by the FDA under 21 CFR Part 58. In addition, Environmental Protection Agency (EPA) also has formed GLP’s both for Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in 40 CFR Part 160 and for Toxic Substances Control Act (TSCA) in 40 CFR Part 792.

GLP’s are Quality…

The fact of about 120 million individuals being affected by HIPAA breaches in 2015 highlights two important points:

1. There is a mad demand for these records in the black market, which is why they are being targeted to this extent. Any wonder that PHI is in greater demand in the black market than even social security and credit cards?
2. There…

The 60601-1 is a standard that relates to the safety of medical electrical equipment. This harmonized standard is recognized by most countries around the world. Existing and new medical devices have to comply with the requirements set out in IEC 60601-1.

The IEC 60601-1 is going through its latest revision, its 3^rd edition,…

Overview of this session Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.

You’ll learn techniques that can help you identify hazards and potential harms. You’ll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective…

When people with autism spectrum disorder (ASD) –called just autism –enter college, they are up against challenges that are unique and peculiar to the group. They need to be understood for their special needs, because they enter college at a sensitive age. There is an onus on the part of the other people in the college, such as peer students and staff and those in…

Letters of Credit are the primary instruments for assuring payment of goods sold internationally. This web session is designed to provide attendees with an end-to-end understanding of the L/C (letter of credit) process. From the beginning of a contractual agreement, through the letter of credit application process and actual negotiation of the L/C, this information-rich webinar will provide techniques that are indispensable to both importers and exporters.…

Microsoft Excel comes with a myriad of tools such as sorting, filtering, and subtotal to manage large lists of data. Yet, when it comes to analyzing all that data and doing it quickly, the MS Excel PivotTable is a very useful feature. It is particularly important and useful when the user is required to quickly create a compact summary report (based on lots of data) without needing to write complex formulas or rely on lengthy techniques.…

It goes without saying that preparing for HIPAA enforcement is of crucial importance to organizations. The reason: Last year saw a spike in the settlement payments ordered by HIPAA. There were as many as seven settlements of a value of over $1 million each. Of these seven, one was for $5.5 million, another was for $3.9 million, and yet another for $2.75 million. These constituted a part of a dozen or so overall resolutions settlements. These results point to the fact that HIPAA is continuing…