The eCTD is mandatory for all applications for marketing approval and all subsequent related submissions in the European Economic Area, the USA and Canada. Other countries intend to make its use mandatory. The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of medicinal product dossiers for regulatory applications. It broadens the scope of the CTD to include information on variations, renewals and amendments, so that it is no longer a static document but is updatable throughout the life of the product. This module outlines the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission. The module provides a training and reference tool that will be of particular value to those new to the use of the format.
The module describes general principles of GCP inspection and audit, discusses preparation for an inspection, and sets out in detail what European and US FDA inspectors will examine. Finally it describes post-inspection actions by the regulator and the inspected party.
This Level 7: Business Management course is appropriate for both eager novices and seasoned professionals. Through this course, you will learn everything you need to know to start or progress your career in Business Management at the highest possible level. It will help you develop technical abilities as well as a deep understanding of business management. The course will educate you on operational management, risk management, succession planning, project management, and others. You can also learn about numerous strategic techniques and business management preparation in this Training Tale Level 7: Business Management course. Additionally, this step-by-step online course will teach you how to respond to issues that arise during running a business, helping you make well-informed management decisions. Enrol today and take the next step toward achieving your personal and professional goals. Learning Outcomes At the end of the course, the learner will be able to: Provide a brief idea about Business Management and its importance. Discuss all the terms related to Business Management. Clarify the differences between a leader and a manager. Describe the theory of leadership and management to encourage organisational direction. Determine the personal and technical skills needed to attain strategic objectives. Develop a personal improvement plan. Describe the concepts of strategic business management. Understand the UK law and regulations related to business. Develop an action plan for an organisation. Why Choose Level 7: Business Management Course from Us Self-paced course, access available from anywhere. Easy to understand, high-quality study materials of Business Management. Developed by industry experts. MCQ quiz after each module to assess your learning. Automated and instant assessment results. 24/7 support via live chat, phone call or email. Free PDF certificate as soon as completing this course. **Courses are included in this Business Management Course** Main Course : Level 7: Business Management Course GIFT COURSES Course 01: Level 7 Diploma in Facilities Management Course Course 02: Level 5 Retail Management Course Course 03: Level 5 Diploma in Risk Management Course Course 04: Level 4 Time Management Course Course 05: HR and Payroll Management Course 06: Level 5 Report Writing Course Course 07: Workplace First Aid Training Course 08: Fire Safety Level 2 Course 09: Property Management Course 10: Level 2 Customer Service Course 11: Childcare and Nutrition Course 12: Level 1 Diet and Nutrition Course Course 13: Level 5 Health and Safety at Work Course 14: Level 5 Diploma in Nutrition Course Course 15: Level 4 Diploma in Child Counselling Course Course 16: Level 5 Health and Safety at Work Course 17: Safeguarding Vulnerable Adults Training Course 18: Food Allergen Awareness Training Course 19: Level 2 Food Hygiene and Safety Course **Others Benefits of Business Management** Free 20 PDF Certificate Access to Content - Lifetime Exam Fee - Totally Free Free Retake Exam [ Note: Free PDF certificate will provide as soon as completing the Business Management Course] Course Curriculum *** Business Management *** Module 01: Introduction Module 02: Financial Resource and Investment Management Module 03: Succession Planning Module 04: Risk Management Module 05: Supply Chain Management Module 06: Human Resource Management Module 07: Leadership and Management Module 08: Change Management Module 09: Conflict Management Module 10: Project Management Module 11: Communication Techniques for Business Management Module 12: Entrepreneurship and Small Business Management Module 13: UK Business Law Assessment Method After you have finished Level 7: Business Management Course, you will need to take an electronic multiple-choice exam or Assignment to see if you have grasped everything. To pass the exam and be eligible for the pending certificates, you must achieve at least 60%. As soon as you pass the examination, you will be qualified to request your certification. Certification After completing the MCQ/Assignment assessment for this Business Management course, you will be entitled to a Certificate of Completion from Training Tale. It will act as proof of your extensive professional development. The certificate is in PDF format, which is completely free to download. A printed version is also available upon request. It will also be sent to you through a courier for £13.99. Who is this course for? This Business Management course is highly recommended for: Entrepreneurs. Small business owners. Existing business professionals. Program Manager. Facility Manager. Program Administrator. Students Recent graduates. Requirements There are no specific requirements for this Business Management course because it does not require any advanced knowledge or skills. Students who intend to enrol in this course must meet the following requirements: Good command of the English language Must be vivacious and self-driven Basic computer knowledge A minimum of 16 years of age is required Career path The Business Management Course is designed to give you the skills and knowledge you need to land your dream job, advance at work, go self-employed, or start your own business. Certificates Certificate of completion Digital certificate - Included
Prince2®, PMBOK® Guide, and ISO® 21500: Global Fluency in Project Management Prince2®, PMBOK® Guide, and ISO® 21500: Global Fluency in Project Management The truly internationally qualified project manager: Studies the PMBOK® Guide to understand Uses the PRINCE2 method to succeed Achieves ISO 21500's standard of quality in project management 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.
Let's Help Them to Help Themselves - Through Project Management This video illustrates the application of project management to a humanitarian program created to improve childhood conditions in one of the poorest countries in the world and teach children solidarity and respect for others. All of this is achieved through the diffusion of the PM methodologies, both in Congo and in Italy. 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.
Effective Hiring Interview Technique for Selecting Project Managers Do you ever get an uneasy feeling when you realize that you are not sure if the PM you just hired will really be successful? If you are like me, then you have been through this angst. You can reduce the risk of hiring the wrong PM for your organization by following these interview techniques. 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.
Recipes for Strategic and Agile Portfolio Management Sara Nunez is co-author of Organizational Project Management: Linking Strategy and Projects and a recognized PMO Leader in the 2014 AMA PM Handbook. In this presentation, she will show you how to take action and transform the portfolio management discipline in your PMO function, taking into account changes in the marketplace, digital business, and new regulations. 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.
Making the Shift: Project Manager to Scrum Master Working within an Agile environment requires more than learning a framework or process. This scenario-driven presentation will address how we traditionally react to the organization and teams as a project manager, and the mental models and behaviors we need to adopt to successfully shift to agility. 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.
Effective Hiring Interview Technique for Selecting Project Managers Do you ever get an uneasy feeling when you realize that you are not sure if the PM you just hired will really be successful? If you are like me, then you have been through this angst. You can reduce the risk of hiring the wrong PM for your organization by following these interview techniques. 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.
Recipes for Strategic and Agile Portfolio Management Sara Nunez is co-author of Organizational Project Management: Linking Strategy and Projects and a recognized PMO Leader in the 2014 AMA PM Handbook. In this presentation, she will show you how to take action and transform the portfolio management discipline in your PMO function, taking into account changes in the marketplace, digital business, and new regulations. 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.