For safety, every new drug must pass rigorous tests in controlled preclinical or non-clinical studies. Good Laboratory Practices (GLPs) ensure stringent integrity of resulting data, and can determine whether a new chemical entity will enjoy further development or cast aside. COBBLESTONE courses can prepare you to design, develop, structure, source, execute, and analyze studies during this critical discovery phase to give your novel molecule the best chance of success.
To get to market, every new drug must also be shown safe and effective in humans. These controlled clinical studies must be administered in accordance with strict, previously-approved protocols. COBBLESTONE training can help you effectively develop and execute such studies during Phase 1, Phase 2, and Phase 3 drug development for highly successful studies instead of costly failures.
In-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 MoreNavigating Digital Marketing and Clinical Claims in the Cosmetic Industry
The rules and regulations regarding supporting advertising claims for cosmetics have not changed. A claim cannot represent a cosmetic as a drug; the basis for claim support still needs to be consumer perceptible. However, the new vectors for sales and marketing via social media and website sales have brought forth a new paradigm for developing… Continue reading Navigating Digital Marketing and Clinical Claims in the Cosmetic Industry
Read MoreGood Clinical Practice
The concept of Good Clinical Practice (GCP) goes beyond a mere collection of guidelines and complex, challenging language to interpret. It encompasses the culmination of years of progress and revelations in the field of medicine, encompassing both well-intentioned and misguided human decisions, along with consequences that range from unfortunate to truly horrifying. GCP serves as… Continue reading Good Clinical Practice
Read MoreEffective and Compliant Technical Writing
This technical writing training program will offer you an understanding of how the reporting process supports products in research, development, and in the marketplace. This training will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train you on effectively reviewing… Continue reading Effective and Compliant Technical Writing
Read MoreAuditing Stability Programs: How to Ensure a Compliant Program
A significant number of 483’s and Warning Letters related to the stability function is proof that not all companies have an adequate program in place. Since regulatory requirements and guidance’s provide only a general picture of expectations for stability programs, much interpretation is left up to individual companies. A better understanding of regulatory expectations and… Continue reading Auditing Stability Programs: How to Ensure a Compliant Program
Read MoreAn Introduction to the Preparation, Packaging and Labelling of Clinical Trial Supplies
Clinical studies are essential to ensuring the safety and effectiveness of new drug products before they are launched. The cornerstone of these studies is the clinical supplies, which must be properly labeled and prepared to ensure patient safety as well as prevent expensive clinical trial delays. To provide a high-level overview and introduction to the… Continue reading An Introduction to the Preparation, Packaging and Labelling of Clinical Trial Supplies
Read MoreStability Operations for Drugs, Biologics and Medical Devices
This accredited course focuses on the operational aspects of the stability function as practiced by the pharmaceutical, biological and medical device industries. Establishing and maintaining strong stability operations programs will be covered, including: SOPs, training, protocols, life cycle stability strategies, storage conditions, chamber maintenance, and monitoring, trending data and sample management. Preparing for inspections and… Continue reading Stability Operations for Drugs, Biologics and Medical Devices
Read MoreStability Testing for Protein Drug Products & Substances
No drug substance or drug product is acceptable without a satisfactory stability profile. Yet, protein drug substances and drug products offer unique challenges when it comes to stability. From storage to handling, to testing, proteins often require thinking creatively to achieve an acceptable stability program. This intensive course provides comprehensive and up-to-date knowledge of developing… Continue reading Stability Testing for Protein Drug Products & Substances
Read MoreHow to Conduct Robust Root Cause Investigations for CAPA
One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, release of a sub-standard product, or product recall. Furthermore, costly… Continue reading How to Conduct Robust Root Cause Investigations for CAPA
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