Transform Your TMF Management With A Validated LMS
The clinical phase accounts for 69% of overall R&D costs, resulting in a need to try to reduce costs. An area that can keep a trial on track both time-wise and financially is addressing delays due to compliance inadequacies. In other words, effectively managing your Trial Master File (TMF) can mean the difference between trial […]
Choosing the right LMS for a CRO: meeting regulatory demands and enhancing training efficiency
The latest market research predicts that the LMS market will reach a value of $28.1 billion by the end of 2025, with adoption rates in North America of 70% from 2020. In other words, e-learning platforms have become essential to the life and growth of a company. For the pharmaceutical Industry? Even more so, especially for the […]
Ensuring 21 CFR Part 11 Compliance With Dokeos: A Guide For Quality Control
Since its introduction in 1997, the FDA’s 21 CFR Part 11 has provided rules on the management of electronic records and electronic signatures in the pharmaceutical and biotechnology industries. The latest update was published on October 1, 2024. It provides a guide to using electronic records in clinical investigations, helping stakeholders adhere to good clinical […]
Ensuring Good Distribution Practice (GDP) Compliance With GxP Training
Between 2020-2023, the U.S. reported 107 medical device recalls; the most common recall was due to quality control. Emphasizing the need for manufacturers to maintain medical device quality and safety throughout the supply chain. Good Distribution Practice (GDP) is a set of international standards and guidelines that protect a medical device’s quality, safety, and efficacy […]
Workplace Safety: OSHA Compliance for Manufacturing Companies
The Occupational Safety and Health Administration (OSHA) has strict standards for the manufacturing sector. The aim is to prevent and reduce workplace injuries and fatalities, many of which are preventable and due to negligence. In fact, there were 373,300 recorded incidences of non-fatal injuries on the manufacturing work floor in 2020, according to a U.S. […]
Streamlining FDA Compliance Training for Pharmaceutical Companies
U.S. pharmaceutical companies are regulated by the Food and Drug Administration (FDA). It oversees every step of the process, from the manufacturing to the advertising of drugs and medical devices. This makes pharmaceutical training on FDA compliance critical. Failure to comply can result in hefty fines, reputational damage, and civil lawsuits. Give your staff the […]
Navigating HIPAA Compliance: Pharmaceutical Best Practices
Under provision §160.103, any health sector involved in the “sale or dispensing of a drug, device, or equipment,” is subject to HIPAA laws. This entails the pharmaceutical industry, even those based overseas if they serve U.S. clients and exchange information electronically. Compliance isn’t always easy in practice, especially with the seemingly endless page-after-page of formal […]
Safety and Compliance training in Pharmaceutical Manufacturing
GmP guidelines establish compliance and safety standards for work floor operations and product quality assurance. The regulations are set by governing bodies like the World Health Organization (WHO) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S). The guidelines are extensive and can be cumbersome to navigate. Fortunately, training in pharmaceutical manufacturing can be managed on a […]
Safety and Compliance in Manufacturing: A Guide to E-learning Solutions
Safety is paramount in an industry that involves heavy use of assemblies and machinery. Employee welfare should be at the core of every safety and compliance plan. It starts with education, and the optimal way to get your employees up to speed is via e-learning solutions. Learn how online training fosters adherence to compliance and […]
From Compliance to Competency: How LMS Drives Employee Growth
In September 2023, the California-based healthcare agency LA Care Health Plan paid $130,000 in penalties and had to present a corrective action plan to HIPAA. The penalty stemmed from a processing error that enabled customers to access the data of other members. Exposed information included names, addresses, and member identification numbers. Regulatory bodies for most […]
