Good Manufacturing Practice (GMP) is a set of rules for medicines manufacturers to follow so that their products are safe, effective, and of good quality. Everyone who works in a processing, quality control, packaging, or warehouse environment for a pharmaceutical or biotechnology company, or one of their contractors, must understand why GMP is important, how it applies to them, and how to comply with it. This short course explains what GMP is and why it is important, and it gives some lessons from history. It introduces the regulations and guidance documents that are the source of GMP rules. Finally, it touches on regulatory inspections and the consequences that can arise from failure to comply with GMP requirements.
Capture and management of clinical trial data is a challenge. The industry is under pressure to obtain and analyse such data more quickly, while maintaining data integrity, so that products can be brought to market sooner. Effective planning and adequate resources can ensure clinical trials yield high quality data within strict timelines and budget requirements, at the same time satisfying regulatory standards. This short course describes the purpose of data capture and explores efficiencies in data management as part of the evolving regulatory landscape.
The demands on quality from clinical trials are increasing. Quantitative aspects of clinical trials, such as the mass of study data to be collected, the multiple investigational sites, and the need to meet predetermined timelines, often supersede qualitative features. Therefore, addressing basic requirements for quality management is essential when preparing a clinical trial. This short course describes the core elements required for the establishment of a clinical trial and provides an overview of the role of the sponsor in supporting and improving trial quality.
In clinical trials, endpoints are measurements to evaluate the results of a new treatment, at an individual patient level. The study data can be extrapolated to patient populations on the basis of clinical similarities to patients participating in the trial. When clinical trial data have been obtained, focus is on the trial endpoints; more specifically, the focus is on whether the trial met or failed the primary endpoint specified before the trial started. The purpose and various types of endpoints are discussed in this short course.
Clinical trial protocols are an essential part of clinical trial design. Protocol documents are critical to conducting safe and cost-effective investigations. Protocol documents are large and complex, containing comprehensive information relating to purpose, design and conduct of a clinical trial. Aspects of a protocol include patient eligibility criteria, and treatment specifications. This short course provides an overview of clinical trial protocols. Opportunities to improve a clinical trial protocol for regulatory approval are also discussed.
In this short course we present an overview of the main principles of GMP, and we outline some things that manufacturing personnel need to do to comply with requirements. We identify the principal goals of GMP as: prevention of contamination; prevention of mix-ups; scrupulous documentation; validation and maintenance of processes and equipment; quality assurance by an independent unit; and training. We place GMP in the context of a company’s quality management system.
Clinical trial design establishes the framework upon which the clinical trial process will be conducted, and sets the objectives of the trial. The application for marketing approval, submitted to the regulatory authorities, will provide clinical data reflecting the trial design. Since trial design impacts the whole drug development process and lifecycle, particular care and due diligence is essential. This short course provides an overview of the main types of study design.
Prevention of contamination is one of the most important goals of GMP. Contamination of product is often difficult to detect, so GMP rules emphasise preventive measures, including: attention to personal health and hygiene, and the wearing of special clothing, by staff; and cleaning and sanitation of premises and equipment. In this short course we set out the basics of GMP requirements in these vital areas.
Comprehensive documentation of procedures, formulas, work instructions, and specifications, and thorough recording of batch data, are fundamental requirements of GMP. In this short course we explain why documentation is so important, identify different types of document required, and set out some simple rules for recording and correcting data.
Teaching Skills Bundle - Overview ***With this Teaching Skills Bundle Course, get a Personal Hygiene Course completely FREE and prevent yourself from being infected by Coronavirus and other contagious diseases.*** With soaring demand for skilled educators in the UK and USA, investing in your teaching prowess has never been more crucial. Schools and institutions are actively seeking educators who can create engaging classrooms. Our comprehensive Teaching Skills Bundle empowers teachers like you to excel in your profession and foster a dynamic learning environment. Additionally, the USA & UK student population is expected to grow by 9% & 10% by 2030, making it the right time to learn teaching skills. This Teaching Skills Bundle is packed with four courses to boost your teaching skills to the next level. Versatile teaching skills will help you stand out amongst the crowd. Thus, the course begins with teaching you the art of Classroom Management to create a harmonious learning atmosphere. The Speaking Training for Teachers course of the Teaching Skills Bundle bundle will help you to develop platform skills, engage with students, and use storytelling to make learning unforgettable. As you move to the next course, the Time Management Diploma, you will gain expertise in controlling your time and productivity to achieve your teaching goals. Besides, you will gain the ability to build a toolbox of time management strategies and establish a clear action plan. The last course of the Teaching Skills Bundle bundle will increase your proficiency in teaching English effectively in the classroom. Enrol in the Teaching Skills Bundle to turn your teaching career into an excellent one. The course can be studied part-time. You can become accredited within 9 hours studying at your own pace. Your qualification will be recognised and can be checked for validity on our dedicated website. Why Choose Teachers Training Some of our features are: This is a dedicated website for teaching 24/7 tutor support Interactive Content Affordable price Courses accredited by the UK's top awarding bodies 100% online Flexible deadline Entry Requirements No formal entry requirements. You need to have: Passion for learning A good understanding of the English language Numeracy and IT Desire for entrepreneurship Over the age of 16 Assessment The assessment is straightforward, you need to complete the assignment questions that will be provided to you at the end of the course, you can complete the assignment anytime you want. After you complete and submit your assignment, our tutors will assess your assignment and give you feedback if needed. After your assignment has been assessed and you have passed, you will be qualified and will be able to apply for a course completion certificate. Certification CPD Certification from The Teachers Training Successfully completing the MCQ exam of this course qualifies you for a CPD-accredited certificate from The Teachers Training. You will be eligible for both PDF copy and hard copy of the certificate to showcase your achievement however you wish. You can get your digital certificate (PDF) for £4.99 only Hard copy certificates are also available, and you can get one for only £10.99 You can get both PDF and Hard copy certificates for just £12.99! The certificate will add significant weight to your CV and will give you a competitive advantage when applying for jobs. Classroom Management Training for Teachers Introduction to Teach Like a Champion Introduction Teach Like a Champion 00:10:00 Classroom Management How to Avoid Students Disrupting the Class 00:11:00 How to Stop Distruptions Once They Begin 00:09:00 Choosing an Appropriate Seating Arrangement 00:03:00 Choosing the Best Communication System for the Class 00:10:00 Planning The Critical Importance of Planning 00:08:00 How to Plan an Effective Lesson 00:09:00 How to Plan an Effective Units 00:06:00 How to Plan for the Whole Semester 00:05:00 Assessments and Grading Creating Effective Assessments 00:08:00 Efficient Grading Techniques 00:06:00 The Power of Formative Assessment 00:10:00 The Strengths and Weaknesses of Summative Assessment 00:04:00 Relationship Management Developing Healthy Relationships with Students 00:08:00 Communicating Effectively with Parents 00:05:00 Managing Management, How to Deal with the Boss 00:06:00 Psychological Tools for the Champion Teacher 00:05:00 Conclusion Review the Key Ideas of the Course 00:06:00 Understanding Child Development for Teachers Factors That Influence Development 00:39:00 Cognitive Development 00:25:00 Social and Emotional Development 00:44:00 Personality and Intellectual Development in Children 00:39:00 Stages of Language Development 00:29:00 Understanding Moral Development 00:20:00 Speaking Training for Teachers Your Students Will Never See You Practice How Teachers and Educators Can Lecture More Effectively 1st Video Rehearsal 00:02:00 How Teachers and Educators Can lecture More Effectively 2nd Video Rehearsal 00:02:00 How Teachers and Educators Can lecture More Effectively 3rd Video Rehearsal 00:04:00 How Teachers and Educators Can Lecture More Effectively Any Subject Can be Interesting and any Subject Boring 00:02:00 How Teachers and Educators Can Lecture More Effectively Conclusion 00:01:00 How Teachers and Educators Can Lecture More effectively Discipline 00:06:00 How Teachers and Educators Can Lecture More Effectively Feedback 00:02:00 How Teachers and Educators Can Lecture More Effectively Focus on top Five Principles 00:05:00 How Teachers and Educators Can Lecture More Effectively Intro 00:01:00 How Teachers and Educators Can Lecture More Effectively Look at Your Video 00:02:00 How Teachers and Educators Can Lecture More Effectively Passion 00:04:00 How Teachers and Educators Can Lecture More Effectively Platform Skills 00:05:00 How Teachers and Educators Can Lecture More Effectively Promo 00:01:00 How Teachers and Educators can Lecture More Effectively Questions 00:05:00 How Teachers and Educators Can Lecture More Effectively Stories 00:06:00 How Teachers and Educators Can Lecture More Effectively Wireless Microphone 00:06:00 Time Management Diploma Identifying Goals Identifying Goals 00:11:00 Effective Energy Distribution Energy Distribution 00:10:00 Time Logs 00:11:00 Working with Your Personal Style Personal World View 00:10:00 Strengths 00:09:00 Building Your Toolbox Building Your Toolbox 00:11:00 Establishing Your Action Plan Establishing Your Action Plan 00:11:00 Teaching Kids English Introduction Introduction 00:06:00 Studying Top Tips Sentence Types 00:04:00 Connectives 00:02:00 Connectives Contrast 00:02:00 Paragraph 00:02:00 Comprehension 00:04:00 Figurative Language 00:05:00 Adjectives 00:04:00 Adverbs 00:02:00 Adverbs 2 00:02:00 Synonyms 00:01:00 It's and Its 00:02:00 There, They're and Their 00:02:00 SEN Support & High Quality Teaching Techniques for Teachers SEN Support 00:13:00 High Quality Teaching for Pupils with SEN 00:09:00