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 […]
Strengthening Pharma Compliance: CAPA Training for Quality Standards
Corrective action and preventive action, or CAPA, is an organizational method for identifying, investigating, and resolving issues that may manifest during a product development, testing, or release phase. Pharma manufacturing and medical device industries are mandated to have a CAPA plan in place under the Food and Drug Administration (FDA) and International Organization for Standardization […]
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. […]
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 […]
How to Develop your employees skills in the manufacturing industry?
With the emergence of technology and AI in particular, manufacturing processes are evolving at an unprecedented pace. With this comes new practices on the warehouse and assembly lines. The key is to develop innovative training approaches in a way that’s convenient, flexible, and time-efficient. The solution for fostering employee skills in this manner lies in […]
Boosting Productivity: Integrating LMS with HR Workflows
Boosting productivity should be at the core of every HR corporate resolution plan. Employees who are productive and maximize their time on the clock impact the company’s bottom line, directly or indirectly. LMS as part of a broader digital adoption initiative can be a significant game-changer in positively changing employee attitudes, confidence, and productivity. Learn […]
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 […]
Accelerating Pharma Workforce Skills Through Dokeos LMS
The pharmaceutical sector is an ever-evolving industry, utilizing the latest in AI and machine learning to produce breakthroughs in medical science. While technology has been largely a force for good, it does require workers to keep up to date with the constant evolution in technology and regulations. The optimal solution is a remote learning environment […]
Compliance Training Challenges: Dokeos LMS for Regulatory Training
Navigating the intricate waters of industry regulations demands more than just knowledge; it requires mastery. Whether in the B2B or B2C sector, most industries have their respective regulatory bodies. Compliance competence and proficiency are a must to ensure procedural integrity, avoid fines, and prevent reputational damage. However, regulatory training isn’t always easy to implement. Learn […]
