21CFR11 applies to records that are required to be submitted to the FDA, or that are subject to FDA inspection, and that are in electronic form – that is, as computer files. It applies to all computer systems used to create, modify, maintain, archive, retrieve, or transmit such records – from a humble spreadsheet program to a complex information management system.
The warehouse plays a crucial role in a medicinal products factory. This module explains the requirements of Good Manufacturing Practice (GMP) for the warehouse, and how to comply with them.
This module addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of biological medicinal products such as those based on mAbs differ in certain respects from those for small-molecule products. This is because of the distinct characteristics of biologics, such as complex structure and susceptibility to variation during manufacture.
The CTD is the internationally recognised standard format for submissions to medicines regulatory authorities. In the European Economic Area, the USA and Canada, the CTD, in its electronic format (eCTD), is mandatory for all applications for marketing approval and all subsequent related submissions. The CTD is accepted in many other countries, being mandatory for new prescription medicines in some. This module explains the rationale for the CTD and provides guidance on its structure and format and the ways in which it is used.
Level 7 QLS Endorsed Course | Endorsed Certificate Included | Plus 5 Career Guided Courses | CPD Accredited
Brazilian BBL Non-Surgical Buttock Enhancement What is Non-Surgical BBl? A non-surgical Brazilian Bum Lift is a safe and non-invasive way to lift the sculpt the shape of your bum. Using our specialist equipment, focused heating causes the contraction of the fibres in your bum, resulting in an immediate tightening of your skin in this area. This Lipofirm technology used in our treatments brings increased smoothness and softness to the skin, in addition to the tightening and lifting that will help you to feel so much better about an area you may not be comfortable with. Course content: Health and safety Sterilisation and disinfecting The appearance of the therapist Ergonomics About Brazilian bum lift enhancement Electricity Skin laxity Epidermis & dermis Hypodermis Weight gain Subcutaneous fat White and brown adipocytes Cellulite Mechanical lymphatic drainage Electrical muscle stimulation Skin tightening - radiofrequency Fat reduction - radiofrequency Contra-actions Contra-indications Aftercare Treatment protocol for bum lift Training Kit(if purchased) Training Kit(if purchased) Machine 3x suction cups 150ml, 90ml,80ml How does the course work? The course is divided into 2 parts, the first part is theoretical which you have to complete before you come for your practical training, and the second one is a practical assignment. The practical assignment is done on the day which will be agreed upon course purchase. You will spend around 2-3 hours practising on a model in our venue in London E106RA. Will I require a model? Yes, usually 1 model is required Do I Need Experience Before Booking a Course? We’re pleased to offer courses to people with lots of different experiences. However, previous experience nor qualifications are not necessary if you would like to enrol on our Course. Certificate You will receive an end of course certificate which is accredited by the cpd group and allows you to work on public PAYMENT Payments are non refundable. By paying for the course you agree to our terms and conditions.
Simply speaking, Life Coaching is about raising awareness of how we can move from A to B. Sometimes we don't know what place B is, and we can use Coaching to gain clarity on what B looks and feels like. Life Coaching is non-directive, which means as a Coach, I help you to unlock your potential rather than tell you what to do. The experience creates a space for accountability and motivation to take positive action. My role as your Holistic Coach is to provide you with a safe space for you to ground, explore & embrace your emotions, claim your personal power to design & live your dream life.
Give a compliment to your career and take it to the next level. This Phlebotomy bundle will provide you with the essential knowledge to shine in your professional career. Whether you want to develop skills for your next job or elevate your skills for your next promotion, this Phlebotomy bundle will help you stay ahead of the pack. Throughout the Phlebotomy programme, it stresses how to improve your competency as a person in your chosen field while also outlining essential career insights in the relevant job sector. Along with this Phlebotomy course, you will get 10 premium courses, an originalhardcopy, 11 PDF certificates (Main Course + Additional Courses) Student ID card as gifts. This Phlebotomy Bundle Consists of the following Premium courses: Course 01: Phlebotomy Course 02: Medication Administration Level 4 Course 03: Sterile Services Technician Training Level 4 Course 04: Infection Prevention Training Course 05: Community Practice Nurse Course 06: Nurse Prescribing Diploma Course 07: Human Anatomy and Physiology Course 08: Adult Nursing Diploma Course 09: First Aid Training Course 10: Personal Hygiene Course 11: Health Awareness and Social Care Training Enrol now in Phlebotomy to advance your career, and use the premium study materials from Apex Learning. The bundle incorporates basic to advanced level skills to shed some light on your way and boost your career. Hence, you can strengthen your Phlebotomy expertise and essential knowledge, which will assist you in reaching your goal. Moreover, you can learn from any place in your own time without travelling for classes. Course Curriculum of Phlebotomy Module 01: Introduction to Phlebotomy Module 02: Blood Circulation, Function, and Composition Module 03: Phlebotomy Equipment Module 04: Routine Venipuncture Module 05: Venipuncture Complications and Pre-Examination Variables Module 06: Dermal Puncture in Phlebotomy Module 07: Quality Assessment and Management Module 08: Special Blood Collection Procedure Module 09: Infection Control and Risk Management Certificate: PDF Certificate: Free (Previously it was £6*11 = £66) Hard Copy Certificate: Free (For The Title Course: Previously it was £10) CPD 115 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Anyone from any background can enrol in this Phlebotomy bundle. Requirements This Phlebotomy course has been designed to be fully compatible with tablets and smartphones. Career path Having this expertise will increase the value of your CV and open you up to multiple job sectors.
Discover the art of supporting mothers through the miracle of childbirth and become a trusted pillar of strength during this transformative experience. In this course, you will learn the intricacies of childbirth and gain a profound understanding of maternal health, baby care, and child development. This course is worth investing in for aspiring learners because it offers a diverse range of modules that equip you with the skills and knowledge needed to excel in the field of midwifery and childcare. This course covers everything from mastering the techniques of safe delivery to ensuring infection prevention, from nurturing the newborn with baby massage to understanding the psychological development of children. With certification in health and social care, safeguarding, and paediatric first aid, you'll be fully prepared to provide essential care and support to mothers and their precious little ones. Join us on this rewarding journey and be the beacon of hope and comfort for countless families. This Comprehensive Midwifery Training: Prepare for a Rewarding Career Bundle Consists of the following Premium courses: Course 01: Midwifery Training Course 02: Birth Doula Course 03: Health and Social Care Level 2 Course 04: Infection Prevention Training Course 05: Maternity Care Assistant Course Course 06: Personal Hygiene Course 07: Baby Massage Course 08: Neuropsychology and Development of Children Course 09: Safeguarding and Protection for Children Level 2 Course 10: Childcare and Nutrition Course 11: Paediatric First Aid Level 3 Learning Outcomes Upon completion of this bundle, you should be able to: Demonstrate proficiency in the fundamental principles and practices of midwifery. Understand the role and responsibilities of a birth doula, providing continuous physical and emotional support to expectant mothers during childbirth. Implement infection prevention measures effectively in healthcare settings, minimising the risk of cross-contamination and ensuring patient safety. Assist in maternity care as a trained Maternity Care Assistant, providing essential support to midwives and mothers during childbirth. Comprehend the principles of neuropsychology and child development, enhancing their ability to provide holistic care to children. Demonstrate proficiency in paediatric first aid at a Level 3 standard, responding effectively to medical emergencies involving children. Our comprehensive Midwifery course is a transformative journey that equips learners with a profound understanding of the art and science of childbirth and childcare. In Midwifery Training, students delve deep into the world of midwifery, mastering the skills and knowledge necessary to provide compassionate care and support during childbirth. This training not only covers the intricacies of childbirth but also imparts essential expertise in maternal health, ensuring that learners can confidently guide expectant mothers through this miraculous journey. As part of our holistic approach to healthcare, Birth Doula prepares learners to be a vital source of comfort and reassurance to expectant mothers during labour and delivery. With Neuropsychology and Development of Children, students gain insights into the psychological aspects of child development, enriching their ability to provide comprehensive childcare. Our commitment to child welfare is further reinforced through Safeguarding and Protection for Children Level 2, where learners acquire the necessary skills to ensure children's safety and well-being. The significance of infection control is not overlooked, with Infection Prevention Training equipping students to maintain a sterile and secure healthcare environment. Health and social care is pivotal for learners to understand the broader context of their role in the healthcare ecosystem. Personal Hygiene underscores the importance of maintaining impeccable hygiene standards in healthcare practice. Baby Massage empowers learners to promote infant relaxation and bonding. Our Midwifery course is an indispensable package that equips learners with a diverse skill set, making them valuable assets in the healthcare and childcare sectors, where their expertise and compassion are needed most. CPD 110 CPD hours / points Accredited by CPD Quality Standards Who is this course for? This course is tailored for: Aspiring Midwives Birth Support Professionals Maternity Care Assistants Healthcare Professionals Childcare Providers Requirements No requirements to enrol this Comprehensive Midwifery Training: Prepare for a Rewarding Career course. Career path Upon completion, various career opportunities include: Registered Midwife Average Salary of £25,000 to £50,000 per year Nurse-Midwife Average Salary of £30,000 to £60,000 per year Maternity Care Assistant Average Salary of £18,000 to £26,000 per year Health Visitor Average Salary of £30,000 to £40,000 per year Midwifery Lecturer or Educator Average Salary of £40,000 to £60,000 or more per year Certificates CPDQS Accredited e-Certificate Digital certificate - Included CPDQS Accredited Hard-Copy Certificate Hard copy certificate - Included You will get the Hard Copy certificate for the title course (Midwifery Training) absolutely Free! Other Hard Copy certificates are available for £10 each. Please Note: The delivery charge inside the UK is £3.99, and the international students must pay a £9.99 shipping cost.
Give a compliment to your career and take it to the next level. This Dermatology bundlewill provide you with the essential knowledge to shine in your professional career. Whether you want to develop skills for your next job or elevate your skills for your next promotion, this Dermatology bundle will help you stay ahead of the pack. Throughout the Dermatology programme, it stresses how to improve your competency as a person in your chosen field while also outlining essential career insights in the relevant job sector. Along with this Dermatology course, you will get 10 premium courses, an original hardcopy, 11 PDF certificates (Main Course + Additional Courses) Student ID card as gifts. This Dermatology Bundle Consists of the following Premium courses: Course 1: Dermatology Course 2: Skin Care Treatment Course 3: Acne Treatments and Beauty Care Course 4: Nutrition and Health Level 2 Course 5: Complete Communication Skills Master Class for Life Course 6: Human Anatomy and Physiology Course 7: Health Awareness and Social Care Training Course 8: Wound Care Level 2 Course 9: Personal Hygiene Course 10: Infection Prevention Training Course 11: Makeup Artistry Course Enrol now in Dermatology to advance your career, and use the premium study materials from Apex Learning. The bundle incorporates basic to advanced level skills to shed some light on your way and boost your career. Hence, you can strengthen your Dermatology expertise and essential knowledge, which will assist you in reaching your goal. Moreover, you can learn from any place in your own time without travelling for classes. Curriculum of Dermatology Bundle Course 1: Dermatology Basics of Dermatology Skin Anatomy Skin Nutrients Diagnosis of Skin Disease Skin Infections Atopic Eczema Care of Different Skin Types Different Ethnicities Skin Care Reducing Ageing Effects Acne and Its Remedies Seasonal Skin Care Effect of the Sunburn and Its' Remedies Certificate: PDF Certificate: Free (Previously it was £6*11 = £66) Hard Copy Certificate: Free (For The Title Course: Previously it was £10) CPD 125 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Anyone from any background can enrol in this Dermatology bundle. Requirements This Dermatology course has been designed to be fully compatible with tablets and smartphones. Career path Having this expertise will increase the value of your CV and open you up to multiple job sectors. Certificates Certificate of completion Digital certificate - Included Certificate of completion Hard copy certificate - Included You will get the Hard Copy certificate for the title course (Dermatology) absolutely Free! Other Hard Copy certificates are available for £10 each. Please Note: The delivery charge inside the UK is £3.99, and the international students must pay a £9.99 shipping cost.