Business is a team sport, and in technical fields the teams are dizzyingly complex. With so many different collaborators, there are innumerable opportunities for projects to bog down. To keep things on track, strong project management is a must.
Foundational project management training is a strong start, but as engineering, manufacturing, and packaging methods evolve – along with changing regulatory processes – a great project manager needs updated training. Fortunately, COBBLESTONE can keep you up-to-date on the latest methods and requirements so you can keep the whole team moving forward.
GMP 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 MoreComputer System Validation: A Regulatory Overview
The ever‐increasing use of computers within the life science industries draws the attention of the FDA and international regulatory agencies. In recent years we have moved from simple record-keeping systems to computer‐controlled processing, manufacturing, devices, and inventory systems. As we look forward to the increasing use of artificial intelligence, we will require increasingly sophisticated computers,… Continue reading Computer System Validation: A Regulatory Overview
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 MoreBasic FDA GLP Training
Before any drug can be used on humans, it must first be proven to be safe through testing on animal models. The FDA Good Laboratory Practice (GLP) regulations were implemented in 1979 in response to the inadequate quality and scientific rigor of nonclinical (toxicology) studies. The FDA GLPs outline the requirements for conducting nonclinical studies… Continue reading Basic FDA GLP Training
Read MoreGood Laboratory Practice for Nonclinical Laboratory Studies
Complying with the principles of Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) is of utmost importance to ensure the reliability and credibility of study data. Nonclinical laboratory studies, also known as preclinical studies, play a vital role as a prerequisite for demonstrating the safety and essential performance aspects of products intended for human use.… Continue reading Good Laboratory Practice for Nonclinical Laboratory Studies
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 MoreGLP Study Director
Benjamin Franklin famously said: “Tell me and I forget, teach me and I may remember, involve me and I learn.” This intensive accredited course has been entirely redesigned with Franklin’s cogent observation in mind so that each person can get involved in problem-solving and thus learn about how to run regulatory studies that must be… Continue reading GLP Study Director
Read MoreGLP and Quality Assurance
Benjamin Franklin famously said: “Tell me and I forget; teach me and I may remember; involve me and I learn.” This course has been designed with this cogent observation in mind so that each person can get involved in problem-solving and thus learn about how to perform the role of Quality Assurance for laboratories undertaking… Continue reading GLP and Quality Assurance
Read MoreGood Laboratory Practices (GLP)
Benjamin Franklin famously said:Tell me and I forget, teach me and I may remember, involve me and I learn. This course has been entirely redesigned with this cogent observation in mind so that each person can get involved in problem-solving and thus learn about Good Laboratory Practice (GLP) Regulations. Overall, the main intent of this… Continue reading Good Laboratory Practices (GLP)
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