Pharmaceutical training in Computer System Validation (CSV) is essential for maintaining compliance with health authorities like Health Canada, the FDA, and the European Union. CSV ensures that computerized systems in healthcare, including pharma and medical devices, are validated for their intended use. This blog introduces CSV’s importance in pharma, the regulatory landscape, and key components. It also highlights a related workshop by AAPS to help professionals gain foundational knowledge. What Is Computer System Validation (CSV)? Pharmaceutical training teaches that Computer System Validation (CSV) ensures a computer system consistently performs as intended, complying with regulatory requirements. This process is vital in.. 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 »
A clinical research monitor wears many hats throughout their career. They may step in as a coordinator of people and processes, an overseer of clinical research, and an expert in document review. Depending on the day, the roles may look different for a clinical research monitor, which requires these professionals to remain dynamic and flexible in their day-to-day tasks. At the Academy of Applied Pharmaceutical Sciences, students in our Clinical Research, Drug Safety and Pharmacovigilance Post-Graduate Diploma Program learn the essential skills required to enter the industry. Many graduates go on to play a vital role in protecting the public.. 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 »
Are you considering a career in the Pharmaceutical Quality Control and Quality Assurance industry? With training in this field, you’ll be qualified to work in pharmaceutical laboratories, utilizing many strategies to ensure that manufactured products and treatments are consistently safe for use. By conducting testing, overseeing manufacturing equipment and utilizing your knowledge of regulatory compliance, you can determine whether pharmaceutical products possess their intended characteristics and identity. While Quality Control (QC) and Quality Assurance (QA) practices have been around for years within pharmaceutical laboratories, technology and other advancements have altered these processes significantly. Not only have labs evolved to improve.. READ MORE »
The pharmaceutical industry is constantly evolving in the field of quality assurance and control. Within that area, professionals are seeking better ways of monitoring their products, through different stages of the supply chain to consumer homes. Safety and security are top priorities. With the emergence of counterfeit markets, authenticating pharmaceutical products is more important than ever. This is where RFID technology comes in. Capable of capturing and relaying data, RFID technology has become a solution for companies looking to ensure quality, improve patient safety, and secure their reputation in the pharmaceutical industry. For students working towards a career in pharmaceutical.. READ MORE »
Pharmaceutical professionals have extensive knowledge to analyze the raw materials, processes, and finished products to determine the safety and efficacy of a new drug. Pharmaceutical quality assurance is a crucial practice in the manufacturing practice. This is where pharmacopeias come into play. Pharmacopeias are documents designed to provide public standards relating to the quality, safety, and efficacy of a drug. Today, pharmacopeias play a major role in the regulatory process and control of pharmaceutical ingredients. Analysts for pharmaceutical quality assurance will draw upon these standards in their methods of quality control. With the global expansion of drug manufacturing and standards,.. READ MORE »
Biotechnology has been a part of human life for centuries and also plays a major role in the pharmaceutical industry today. Typically referred to as biologics or biologic drugs, these products are developed, researched, and used by medical professionals all over the world. Similar to chemically developed drugs, biologics undergo strict regulation to make it to clinical trials and eventually to the market, or into medical facilities. Keep reading for more details about this important sector of the pharmaceutical industry. Biologics and Biotechnology Biotechnology companies exist in a range of industries, including food production, cleaning products, and the manufacture of.. READ MORE »
