47085 Courses in Cardiff delivered On Demand

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.

Companies that use MEWPs need to know what their management and legal responsibilities are and how to ensure the most effective use of MEWPs. This course covers what managers need to know for safe and effective use of MEWPs on site, including planning the job, conducting a risk assessment, selecting the right equipment for optimum cost-efficiency and mitigating all possible risks. In most countries there is a requirement for employers to train all employees who plan, supervise or manage work at height and the use of equipment for such work.

This module outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. The use of information in the ‘Orange Book’ is explained, as is the role of patent certification in the application. The importance of establishing bioequivalence between a generic and its reference product is emphasised. The module specifies the content and format requirements for an ANDA submission and describes the FDA’s review and approval process. An outline is given of the Generic Drug User Fee Amendments (GDUFA) and the law’s effects on industry players.

Changes to the terms of marketing authorisations for medicinal products, called variations in Europe, must be notified to or approved by the relevant regulatory authorities. Variations include changes to the composition of products, their manufacturing processes, the way they are used, or the indications for which they are authorised. Common approaches are adopted within the European Economic Area to variations to marketing authorisations approved through the Centralised, Decentralised or Mutual Recognition Procedures. Recent legislation has substantially modified the regulatory requirements and extended them to purely national authorisations by member states. This module, which is fully up to date with the new legislation, covers the classification of variations into their several types and the regulatory requirements, guidance and procedures to be followed for each type.

The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than producing generic drugs. The US legal framework for the licensure of follow-on biologics, and accompanying regulatory guidance from the Food and Drug Administration (FDA), have been established only in recent years.

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.

🚀 Introduction to Coaching Course: Unlock Your Coaching Potential! 🌟 Discover the art of coaching with our CPD Accredited 'Introduction to Coaching' course. 🎓 Gain insights into the GROW Model, motivation techniques, and advanced questioning skills. Ideal for aspiring coaches and professionals seeking career development.

Risk Management & Outsourcing School Excursions, Camps & Activities Do you contract out school camps, excursions or international tours? If so, you need to understand what risks you've transferred & what risks you've retained. This course steps you through exactly what you need to know when contracting something out.

*** Don't Spend More; Spend Smart*** Life Just Got Better This Summer! Get Hard Copy + PDF Certificates + Transcript + Student ID Card + e-Learning App as a Gift - Enrol Now Tired of browsing and searching for a Motivation, Goal Setting, and Resilience for Life course you are looking for? Can't find the complete package that fulfils all your needs? Then don't worry as you have just found the solution. Take a minute and look through this extensive bundle that has everything you need to succeed. After surveying thousands of learners just like you and considering their valuable feedback, this all-in-one Motivation, Goal Setting, and Resilience for Life bundle has been designed by industry experts. We prioritised what learners were looking for in a complete package and developed this in-demand Motivation, Goal Setting, and Resilience for Life course that will enhance your skills and prepare you for the competitive job market. Also, our experts are available for answering your queries on Motivation, Goal Setting, and Resilience for Life and help you along your learning journey. Advanced audio-visual learning modules of these Motivation, Goal Setting, and Resilience for Life courses are broken down into little chunks so that you can learn at your own pace without being overwhelmed by too much material at once. Furthermore, to help you showcase your expertise in Motivation, Goal Setting, and Resilience for Life, we have prepared a special gift of 1 hardcopy certificate and 1 PDF certificate for the title course completely free of cost. These certificates will enhance your credibility and encourage possible employers to pick you over the rest. This Bundle Consists of the following Premium courses: Course 01: Motivation Skills Course 02: Goal Setting Masterclass Course 03: Resilience Masterclass Course 04: Leadership & Management Diploma Course 05: Career Journey in 2021 and Beyond Course 06: Recovering from a Job Loss in Technology Course 07: Personal and Networking Skills Course 08: Emotional Intelligence and Human Behaviour Course 09: Working Effectively Across Cultures Course 10: Assertiveness and Self Confidence Development Course 11: Stress Management Training Course 12: Biohacking Your Physical and Mental Health Course 13: Self-Help Psychology: Mental Freedom Course 14: Time Management The bundle incorporates basic to advanced level skills to shed some light on your way and boost your career. Hence, you can strengthen your Motivation, Goal Setting, and Resilience for Life expertise and essential knowledge, which will assist you in reaching your goal. Curriculum: Course 01: Motivation Skills Introduction Motivational Skills Motivational Strategies Conclusion Course 02: Goal Setting Masterclass Introduction to Goal Setting Masterclass Module 01: Steps to Reaching Your Goals Module 02: Why Goals Are So Important Module 03: Planning & Setting Goals Module 04: Incorporating Goals into Your Daily Life Module 05: Incorporating Goals into Your Business Module 06: Worksheets and Exercises for Goal Setting Module 07: Conclusion Course 03: Resilience Masterclass Module 01: 3 Reasons Therapy May Help Boost Your Resilience Module 02: 3 Signs That You Are Resilient Module 03: 3 Ways to Boost Your Child's Resilience Module 04: 4 Myths about Resilience to Stop Believing Today Module 05: 4 Reasons Why Resilience Matters in the Workplace Module 06: Become Resilient With the Seven Cs of Resilience Module 07: Top 5 Attributes Of Resilient People Module 08: Top 5 Benefits of Resilience Module 09: Top 5 Ways to Boost Resilience to Overcome Adversity in Life Module 10: What is Resilience? And much more! How will I get my Certificate? After successfully completing the Motivation, Goal Setting, and Resilience for Life course, you will be able to order your CPD Accredited Certificates (PDF + Hard Copy) as proof of your achievement. PDF Certificate: Free Hard Copy Certificate: Free CPD 140 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Anyone from any background can enrol in this Motivation, Goal Setting, and Resilience for Life bundle. Requirements Our Motivation, Goal Setting, and Resilience for Life course is fully compatible with PCs, Macs, laptops, tablets and Smartphone devices. Career path Having this Motivation, Goal Setting, and Resilience for Life expertise will increase the value of your CV and open you up to multiple job sectors. Certificates Certificate of completion Digital certificate - Included