When a drug is given regulatory approval to enter the marketplace, a much broader patient population than documented in clinical trials is exposed to the product. Not only is there less control on drug prescription than in a clinical trial, but there is also the chance that certain populations taking the drug may not have been closely studied. Sometimes, rare adverse effects are not even discovered until a product is in its post-approval phase. As a regulatory affairs professional, you will play an important role in ensuring that pharmaceutical companies keep public safety a priority even after a drug is.. READ MORE »
In the wake of the pandemic, the food industry is under pressure to remain compliant and ensure quality consistency meets health and safety demands today. At the same time, general attitudes toward food are changing, with more consumers demanding transparency about what they eat and where it comes from. Many want to rest assured that their food is free of pesticides and other chemical contaminants. What does this all mean for the food quality assurance industry? Businesses must ensure that there are enough safety guidelines to protect consumers from foodborne illnesses or other issues. In the coming years, we can.. READ MORE »
The field of regulatory affairs has been growing in recent years with the constant innovation and developments of the pharmaceutical industry. At the Academy of Applied Pharmaceutical Sciences, our postgraduate online diploma program provides the comprehensive background and training required to address domestic and international regulatory statutes and laws. With the opportunity for extensive growth in this field, many students quickly realize that the path to a regulatory affairs associate is for them. Continue reading to discover the value of pursuing a role in regulatory affairs after completing the AAPS diploma program. 1. Become Well-Versed in a Wide Variety of.. READ MORE »
The pharmaceutical industry is fast-paced and constantly changing and requires a level of innovation and diligence to be successful. If this sounds like you, then you’ll love the Clinical Research, Drug Safety, and Pharmacovigilance program at AAPS. Our program offers students the opportunity to get hands-on experience with administering and monitoring clinical trials and conducting drug safety and pharmacovigilance activities. Many students go on to fill roles as pharmacovigilance officers at large companies, where they directly apply their studies to their new careers. Gaining experience with encounters you’ll likely have on the job, such as the need to learn Pharmacovigilance.. READ MORE »
A number of different procedures require the use of HPLC validation methods, as you’ll discover when you begin courses in pharmaceutical school. Some of these procedures include: Identification tests Testing for impurities (limit tests or quantitative tests) Assay procedures Dissolution tests Particle size determination Each of these tests uses a specific set of validation characteristics to determine if the substance is suitable for the intended use. During the High Performance Liquid Chromatography (HPLC) course at AAPS, you’ll be introduced to this popular method of compound analysis that’s used in various industries such as the pharma, cannabis, biopharma, food, chemical, environmental,.. READ MORE »
Documentation has long been an important aspect of quality assurance roles across the pharmaceutical industry. While good documentation practices can be especially helpful during audits, inspections, and investigations, their utility doesn’t stop there. Documentation is a mandatory aspect of production at all levels to ensure that the products and processes of the facility remain up to standards. With quality assurance training from the Academy of Applied Pharmaceutical Sciences, you will have the opportunity to work in a state-of-the-art laboratory that simulates working in a GMP environment. By practicing what you’ll be doing in your career down the line, you can.. READ MORE »
A fundamental requirement of the pharmaceutical industry is to ensure the safety and effectiveness of products. Pharmaceutical quality assurance is a vital step in this process and helps to keep all steps and processes in line with good manufacturing practices (GMP). When documentation and data are consistently accurate, then pharmaceutical companies are able to operate and perform as expected. Within pharmaceutical quality assurance roles, this tracking of data is where statistics comes into play. Statistical methods are essential to the operations of any pharmaceutical manufacturing facility, ensuring alignment with standards of quality. Especially considering advancements in technology, coupled with new.. READ MORE »
HPLC, short for high-performance liquid chromatography, is a method of separating a mixture of compounds. HPLC offers a unique advantage, producing highly accurate identification, quantification, and purification of a certain compound or analyte. This allows professionals to perform analysis and determine specific results from the sample’s components and identify the exact substances within a mixture. During the HPLC process, in the stationary phase, a mixture in mobile phase moves through a column at a velocity determined by the nature of the particular chemical, the mobile phase composition, and the type of column. The length of time it takes the components.. READ MORE »
Hazardous material exposure can lead to adverse effects on anyone, whether an unknowing patient or seasoned healthcare professional. Around 75,000 healthcare workers are occupationally exposed to hazardous drugs, from nursing staff to laboratory research workers, causing adverse health effects. The importance of workplace safety and proper hazardous drug handling is essential for anyone looking to complete training in Pharmaceutical Quality Assurance and Quality Control. Students who pursue careers as laboratory technicians, validation chemists, and more can find themselves in direct need of hazardous material handling training, so continue reading to learn 4 basic tips for these situations. 1. Understand the.. READ MORE »
In order to ensure the safety and consistency of the pharmaceutical products we consume, there must be procedures and standards in place that regulate their quality. If you’re considering a career in Quality Assurance, Pharmaceutical Analysis, or Regulatory Affairs, a significant component of your responsibilities will be ensuring that the processes you’re adhering to align with the defined standards. When it comes to understanding how the practices around the development of pharmaceutical products are maintained, the explanation starts with Chemistry, Manufacturing and Controls, or CMC. CMC is integral to the drug development process itself, defining how manufacturers operate throughout the.. READ MORE »
