Timely, accurate analytical data is essential for determining success in chemistry. Even with years of education and experience, chemists often encounter seemingly unsolvable challenges. That’s when other perspectives – especially from informed and helpful experts – can make all the difference.
Our in-depth course can strengthen your skills and knowledge of chemistry, instrumentation, and statistics to solve pressing problems. Increasing your capabilities in analysis, process and product development, and fundamental laboratory research can open the path forward for your career.
Aerosol Technology 101
Aerosols are a unique product form, utilized in an array of industries, that require a thorough understanding of the technology before acceptable formulations can be developed for consumer use. While traditional aerosol products have been around for many years, recent developments in propellants, valve systems, and packaging innovations have opened up new opportunities for new… Continue reading Aerosol Technology 101
Read MoreIn-depth Look into Softgel Formulation, Manufacturing and Troubleshooting
Softgels are widely popular dose forms for liquid that represent the most important oral form for less than 5 milliliters of liquid. Additionally, softgels are vital as a lipid delivery system, enhancing both solubility and permeation of Active Pharmaceutical Ingredients (APIs) by targeting the lipid absorption route. Softgels may appear to be a simple, two-part… Continue reading In-depth Look into Softgel Formulation, Manufacturing and Troubleshooting
Read MoreGMP Change Control Process
Change control is a requirement of all regulatory agencies and authorities worldwide. It is a critical GMP function that must be addressed daily. The value of identifying and tracking change is to prevent unintended consequences, remain in proper process alignment, and avoid any alteration of the products’ Safety, Identity, Strength, Purity, and Quality (SISPQ). Many… Continue reading GMP Change Control Process
Read MorePrecision Tools for Error Reduction
Human error is known to be the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment, many variables that affect human behavior CAN be managed,… Continue reading Precision Tools for Error Reduction
Read MoreIntroduction to Tablet Manufacturing by the Direct Compression Process
Solid oral dosage forms such as tablets and capsules represent the most common type of pharmaceutical products produced. In the patient’s hand, a tablet can seem like a simple product not knowing there are numerous complexities that go into its manufacture. But for the manufacturer, without a clear understanding of the science behind the ingredients… Continue reading Introduction to Tablet Manufacturing by the Direct Compression Process
Read MoreIntroduction to Softgel Manufacturing and Controls
Softgel dosage forms represent a modern take on the traditional tablet product, the most common type of pharmaceutical products produced. In the patient’s hand, a softgel can seem like a simple product not knowing there are numerous complexities that go into its manufacture. But for the manufacturer, without a clear understanding of the science behind… Continue reading Introduction to Softgel Manufacturing and Controls
Read MorePharmacopoeia Compliance: An Overview [FREE WEBINAR]
Compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmacopeia is applicable. This fundamental, and often misunderstood – principle is an important consideration throughout the drug product life cycle across the bio/pharmaceutical industry. Ensuring pharmacopoeia compliance is often complex and the… Continue reading Pharmacopoeia Compliance: An Overview [FREE WEBINAR]
Read MoreHandling OOS Test Results and Completing Robust Investigations
It was the Barr Decision in the early 1990s that first coined the term Out-of-Specification (OOS). Since that landmark case, pharmaceutical companies, both drug and biologicals, have had to perform adequate investigations whenever an OOS result was obtained through laboratory testing. In the nearly 30 years since then, FDA continues to cite companies for not… Continue reading Handling OOS Test Results and Completing Robust Investigations
Read MoreGood Documentation Practices for Laboratory Records
In FDA’s Guide to Inspections of Pharmaceutical Quality Control Laboratories (7/93), it is stated The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regulations (21 CFR 211) pertain to the quality control laboratory and product testing. Good documentation practices are expected… Continue reading Good Documentation Practices for Laboratory Records
Read MoreIQ, OQ and PQ for the Laboratory
The FDA’s 21 CFR Part 211.160 establishes the legal requirement for calibrating laboratory equipment. Now more commonly referred to as Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ), the qualification of equipment in a GMP Laboratory in the Pharmaceutical and Bio Pharmaceutical manufacturing operations are essential parts of the overall validation process and ongoing commercial batch release. Data… Continue reading IQ, OQ and PQ for the Laboratory
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