This module describes the design, development and installation phase, the validation phase, and the operation and maintenance phase of the validation of computerised systems in medicines and healthcare products manufacturing environments. It continues to follow the progress of a pharmaceutical company's project to validate a new dispensary control system.
In the medicines and healthcare products industries, computerised systems used in automated manufacturing or laboratory processes to which Good Manufacturing Practice requirements apply need to be validated. This module describes the planning of such validation. It follows the work of a pharmaceutical company's team as they validate the dispensary control system for a new production line.
Manufacturers of medicines and healthcare products must establish, validate and maintain an equipment cleaning programme. This is a regulatory requirement because validated cleaning procedures contribute to the assurance of product purity and safety. This module provides a comprehensive account of equipment cleaning validation requirements and procedures. It follows the work of a pharmaceutical company's validation team as they establish and validate the cleaning program for a new production line.
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.
Essential to validation is the provision of documented evidence verifying that manufacturing processes will consistently result in products meeting predetermined quality standards. This module describes the purpose, content and use of validation master plans, project validation plans, and other documentation for validation projects in the medicines and healthcare products industries. It describes the activities of a typical validation team as they carry out a project for a pharmaceutical company.
Validation of equipment, services, systems and processes is vitally important in the medicines and healthcare products industries. Regulatory authorities require documented evidence that manufacturing processes will consistently result in products meeting predetermined quality standards. This module provides an introduction to validation and to the regulations and guidance that apply to it. It describes the activities of a typical validation team as they carry out a project for a pharmaceutical company.
Your Authentic Self and Leadership Style What is your Authentic Self? Many leaders still attempt to be one way at work and their true authentic self emerges outside of work. Some believe leadership is acting. For us to be successful agilists, we need to show up as our authentic selves so that we can be true leaders. Based on the work done by Bill George, the creator of the "authentic leadership" approach to management, this session will address: The importance of your authentic self Its impact on your leadership style Traits of authentic leaders Recommended steps towards your own authentic leadership 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.
Your Authentic Self and Leadership Style What is your Authentic Self? Many leaders still attempt to be one way at work and their true authentic self emerges outside of work. Some believe leadership is acting. For us to be successful agilists, we need to show up as our authentic selves so that we can be true leaders. Based on the work done by Bill George, the creator of the "authentic leadership" approach to management, this session will address: The importance of your authentic self Its impact on your leadership style Traits of authentic leaders Recommended steps towards your own authentic leadership 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.
Innovation Simplified: Why Simple Wins Imagine what you could do with the time you spend drowning in mundane tasks like meetings, reports, and emails? Complexity is holding most of us back from creating an innovative culture that embraces really valuable work. Simplification is the solution, and every organization wants to know the techniques to help them eradicate complexity and get back to meaningful work that drives innovative change. Bodell inspires leaders and their teams to consider what it means to have an innovative company. It isn't about creating a culture of cool lounge areas with ping pong tables. More than anything, your culture will be predicated on the work people do every day. If your organization is mired in meetings, emails, and reports, then that is what your culture will be known for; but, wouldn't you rather be known as the company where people are engaged in truly meaningful work every day? Lisa gives you the tools to make this a reality. 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.