Training Management System (TMS) Vs. Learning Management System (LMS)
The pharmaceutical and biotechnological industries are accustomed to change. Regulatory updates, new trends, and emerging information are a constant in this industry. In 2024 alone, the CFR Title 21-Food and Drugs saw approximately 229 section updates, emphasizing the importance of keeping employees informed and trained. What software applications—platforms—are available to address your organization’s training requirements […]
5 Best Practices For Managing Training Records In Medical Device Manufacturing
So far, in 2024, there have been 100 medical device and radiation-emitting product recalls, highlighting the ongoing challenge medical device manufacturers face in maintaining device quality, safety, and efficacy post-approval. How do you prioritize quality throughout the supply chain? Through training records. Medical device companies must establish protocols to identify employee training requirements and to […]
Effective GMP Compliance: Ensuring Quality Control in Pharmaceutical Manufacturing
In the manufacturing sector, GMP, or Good Manufacturing Practices, is more than just a buzzword. It’s a set of protocols and operations that should be company doctrine for all businesses involved in the pharmaceutical manufacturing, testing, and release of end-user products. Find out how to implement and enforce GMP compliance and promote quality control. The […]
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 […]
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 […]
