Pharmaceutical Training

A Closer Look at Canada’s Thriving Medical Device Market for Pros in Regulatory Affairs

In hospitals and doctors’ offices, drugs aren’t the only things responsible for helping patients heal and feel better. Medical devices are a huge category of medical care tools that often go unnoticed, but are crucial to modern day medicine. Medical devices include wheelchairs, medical scissors, and even bandages. They can range from low-tech to high-tech devices and can even include pacemakers. Some of the technologies used to produce them include microelectronics, biotechnology, and even software. Unlike drugs, which dissolve and are absorbed by the body, medical devices are instruments, tools, and implants that can help with everything from diagnosing a.. READ MORE »

GMP Training: A Guide to Self-Audits in Pharma Manufacturing

The pharmaceutical product manufacturing industry has experienced an unprecedented upsurge in growth as of late. In Canada, total pharmaceutical sales have just about doubled between 2001 and 2013 to total sales of $22 billion in Canada alone. This trend is expected to continue and careers that require knowledge of good manufacturing practices (GMP) are expected to grow as well. GMP training teaches students about the purpose and requirements that are needed for the testing, manufacturing, and packaging of pharmaceutical products in Canada. One of the most important GMP practices is self-auditing. Read on to discover how self-auditing practices in pharmaceutical.. READ MORE »

A Guide to Global Pharmaceutical Regulations for Regulatory Affairs Students

Today’s pharmaceutical industry is very much a global market. While traditional economic powers like the United States remain leaders in the field, new drug development, manufacturing, and trade is now taking place in increasingly diverse parts of the world. In fact, the emerging markets China and Brazil are now home to the 3rd and 6th largest pharmaceutical industries in the world. Not only that, but companies are now manufacturing and developing drugs for distribution to a variety of different countries, each with their own regulations and guidelines. As a result, professionals in the regulatory affairs industry now face a tougher.. READ MORE »

A Day in the Life of a Pharmaceutical Quality Assurance Associate

The pharmaceutical industry is one of the most regulated industries on the planet—and with good reason. Whether a pharmaceutical product is providing much-needed pain-relief to a patient or helping to rid them of a tough bacterial infection, pharmaceutical products need to work properly and predictably each time they are taken. That’s why drug manufacturers need to employ dedicated professionals with a top education in order to ensure that pharmaceutical products are always of the highest quality. If you’re interested in this in-demand career path, then completing your diploma in quality assurance and quality control is crucial. Throughout your training, you’ll.. READ MORE »

5 Things You Should Know About the FDA if You’re Taking Regulatory Affairs Courses

Many pharmaceutical products developed and manufactured in Canada are exported to the United States. As a result, while Canadian regulatory affairs professionals answer primarily to Health Canada, they must also pay special attention to the department’s U.S. equivalent, the Food and Drug Administration (FDA). The FDA officially came into being in 1906, after the Food and Drug Act was signed into law, with the aim of overseeing products and ensuring a high standard of “strength, quality and purity.” Over the years, the department’s powers have expanded significantly, and today the FDA regulates everything from food and drug products to potentially.. READ MORE »

Dissolution Testing: An Important Part of Pharmaceutical Quality Assurance

Ensuring the quality of pharmaceutical products is an important task. After all, if a manufacturing mistake produces a batch that dissolves slower than normal, patients might accidentally take an extra dose, thinking that they need the added medication to receive the care they need. While these mistakes are rare, it’s still essential for pharmaceutical quality assurance professionals to test the rate at which drugs dissolve. How do quality assurance experts measure that rate to ensure batch consistency? With the help of dissolution testing. What is Dissolution Testing? Before we can define dissolution testing, we’ll need to look at a few.. READ MORE »

What’s Going on at AAPS – Students Participate in HPLC Lab

Last week, a group of AAPS students performed an identification (ID) test on Acetaminophen drug substance with High Performance Liquid Chromatography (HPLC). Acetaminophen – brand name Tylenol is over the counter drug that could treat headaches, muscle aches, arthritis and reduce fever. This experiment in our Quality Control (QC) laboratory provided students with hands-on experience preparing in standards, samples and mobile phase. Furthermore, students learned how to set-up the HPLC and how to operate the HPLC software, Empower/Millennium. HPLC labs, such as this one, are particularly valuable to students because they prepare them with the necessary technical skills needed for.. READ MORE »

Regulatory Affairs Spotlight: How New Drug Development Works

Drug research is essential to helping medicine advance and finding new ways of fighting illness, but it is a long and complicated process. Just one in every 5,000 compounds that enters preclinical testing actually make it to the marketplace, and companies spend approximately US$500 million per product, with studies taking anywhere from 8 to 15 years. For regulatory affairs professionals involved in new drug development, the barriers to making potentially beneficial products available to the public can sometimes be frustrating. Nevertheless, the regulations are necessary to ensure that drugs are safe and effective. So how does a new drug get.. READ MORE »

Considering HPLC Training? 5 Common Contaminants to Avoid

High Performance Liquid Chromatography (HPLC) is a technique used to analyze samples in a variety of industries, from biological to environmental to industrial and beyond—even throughout the food, drink, and pharmaceutical industries. To master HPLC, you must learn to use chemical techniques to study organic and inorganic compounds in order to analyze their chemical properties. Specialized training can teach you safe and effective ways to identify, separate, quantify, and ultimately purify a wide variety of chemical compounds, regardless of their volatility or stability. But with the risk of impurities ever present, it’s important to ensure contaminants don’t sabotage your future.. READ MORE »

What is HPLC and How Does it Work?

With HPLC training, you can take your pharmaceutical career to new heights by exploring opportunities in a range of fields, including in medical device manufacturing, healthcare and clinical research – among many other possible options. If you are planning to enroll in HPLC courses, or you have recently started your program, read on to learn more about HPLC and how it works. What is HPLC? HPLC, or High Performance Liquid Chromatography, is one of the most common techniques used for separating and purifying organic and inorganic compounds in order to analyze them. Professionals in HPLC careers know that different compounds.. READ MORE »

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