This module describes the requirements that must be met to obtain licensure of a biological product. Subjects covered include the regulatory context, the content and format of the BLA submission, the review process, and provisions for expedited development and review.
Having undergone Installation Qualification, before equipment can be used routinely in production, it needs to undergo Operational Qualification (OQ) and Performance Qualification (PQ). This module describes OQ and PQ requirements and procedures in the medicines and healthcare products industries. It follows the activities of a typical validation team as they carry out a project for a pharmaceutical company.
Before equipment can be used routinely in production, it must first be commissioned and, if necessary, undergo Installation Qualification (IQ). This module describes commissioning and IQ requirements and procedures in the medicines and healthcare products industries. It follows the activities of a typical validation team as they carry out a project for a pharmaceutical company.
This foundation-level module is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance. It describes the principal requirements that must be satisfied to gain and maintain approval to market medicinal products in the USA and Europe. The legal framework and the roles of major players in regulation are presented. The life-cycle of a drug is outlined. The various procedures available for assessment and approval of products are described and their requirements outlined. Obligations to be fulfilled after marketing approval are discussed.
Levers of Project Agility: Effective Sponsorship Levers of Project Agility: Effective Sponsorship You may be using agile processes in your projects, even have extended the use of agile management practices into other areas of business. However, lack of purposeful and appropriate sponsorship can stifle most projects. An under-engaged or over-enthusiastic sponsor can demotivate the team, slowdown decision making and disrupt even best agile processes. In this talk, we will examine the crucial role of the sponsor, their desired attributes and their relation with the project manager, product owner and scrum master to identify the risk factors and provide tips and tools for avoiding pitfalls and having effective sponsors. You may be agile, but a poor sponsor can still hamper project success. We'll examine this crucial role, ideal attributes, and provide tips to maximize sponsor effectiveness. This and other IIL Learning in Minutes presentations qualify for PDUs. Some titles, such as Agile-related topics may qualify for other continuing education credits such as SEUs, or CEUs. Each professional development activity yields one PDU for one hour spent engaged in the activity. Some limitations apply and can be found in the Ways to Earn PDUs section that discusses PDU activities and associated policies. Fractions of PDUs may also be reported. The smallest increment of a PDU that can be reported is 0.25. This means that if you spent 15 minutes participating in a qualifying PDU activity, you may report 0.25 PDU. If you spend 30 minutes in a qualifying PDU activity, you may report 0.50 PDU.
This course is aimed at companies who employ users of display screen equipment, or DSE as it's often called and is intended to be completed by those who will be assessing the DSE set ups of employees. DSE is a term that covers a wide range of equipment. If equipment like this is not set up correctly, users are at increased risk from certain disorders.
This course is aimed at users of display screen equipment, or DSE as it's often called. DSE is a term that covers a wide range of equipment. If DSE equipment like this is not set up correctly, users are at increased risk from certain disorders. As an employee, you share the responsibility to keep people safe at work. That means undergoing relevant training and ensuring that rules are followed.
This course is aimed at anyone that works on licensed premises and gives them an overview of key topics relating to UK licencing law, responsibilities and penalties for breaching these. It also looks in detail at the issue of age verification including an interactive element to support learning in this area.