67390 Courses

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.

We are delighted that this course has won the Bizzie Baby Silver Award 2016 with fantastic reviewers comments including "Excellent quality product! I have already used several aspects of this product in my own home and felt much more confident when applying these helpful skills. This is a small fee when it can help save a child's life. Easy and simple techniques that I'll remember forever!" This is our most comprehensive First Aid course for babies. It is designed for parents and grandparents and for anyone who would like to learn how to help with common medical emergencies in babies. The course includes what to do if your baby is unconscious; CPR and recovery position specific to babies; choking, drowning, head injuries, bleeding, burns, fitting, meningitis and so much more. The course consists of illustrated step by step directions, flow charts, diagrams, videos and test yourself sections fully compatible with all computers and mobile devices. You will be able to stop and start as often as you like and print your Certificate on completion. You have continuous access to this course for 12 months. This is essential training for anyone working with babies and all parents. Our courses empower you with the skills and confidence to provide immediate help to your baby in a medical emergency. Prompt and appropriate First Aid reduces the pain and suffering experienced by your baby and could save their life. It is impossible to cover all eventualities within this course, or to equip you with the knowledge and skills to appropriately diagnose and treat in unpredictable real life situations. If you suspect serious illness or injury, you should always seek immediate professional medical advice. The author has made every effort to ensure the accuracy of the information contained within the course, however this course is merely a guide and the author does not accept any liability or responsibility for any inaccuracies or for any mistreatment or misdiagnosis of any person, however caused. The course material has been written by Emma Hammett, qualified nurse, first aid trainer and founder of First Aid for Life in conjunction with other medical and first aid professionals. If you have any queries concerning this course, please contact emma@firstaidforlife.org.uk Course content: Action in an emergency Keep yourself safe Priorities of treatment Preparing for an emergency Helpful information What to put in your first aid kit Information to give the emergency services Role of the first aider The primary survey – how to help in an emergency Danger Response Airway Breathing Unresponsive and breathing Unconscious and not breathing Breathing problems Choking How to help a choking baby Drowning Step-by-step – how to help a drowning casualty Croup Anaphylactic shock Wounds and bleeding How to treat a bleeding wound Types of wounds Dressings Embedded objects How much blood can you afford to lose? Symptoms of shock Treatment of shock Amputated parts Internal bleeding Knocked out teeth Eye injuries Nose bleeds Objects in nose Objects in ears Burns Poisoning Head injuries Fitting/seizures/convulsions Medical conditions and childhood illnesses Septicaemia/sepsis Meningitis Useful advice Accident forms Final lesson

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.

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.

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.

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.

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.

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 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.

This short, step-by-step guide is designed to give all parents and those working with babies an introduction into the basic skills to help your baby if they have a medical emergency. This course covers the key elements of basic first aid for babies, for example choking, burns, how to put a baby into the recovery position and so much more. This course is not designed to replace a practical course but it will help empower you with skills and confidence to assess what is wrong and implement basic first aid to help. Prompt and appropriate First Aid reduces the pain and suffering experienced by your baby and could save their life. For our most comprehensive online course please visit our First Aid for Babies coursewhich won the Bizzie Baby Silver Award 2016. The course consists of illustrated step by step directions, flow charts, diagrams, videos and test yourself sections fully compatible with all computers and mobile devices. You will be able to stop and start as often as you like and print your Certificate on completion. You have continuous access to this course for 12 months. It is impossible to cover all eventualities within this course, or to equip you with the knowledge and skills to appropriately diagnose and treat in unpredictable real life situations. If you suspect serious illness or injury, you should always seek immediate professional medical advice. The author has made every effort to ensure the accuracy of the information contained within the course, however this course is merely a guide and the author does not accept any liability or responsibility for any inaccuracies or for any mistreatment or misdiagnosis of any person, however caused. The course material has been written by Emma Hammett, qualified nurse, first aid trainer and founder of First Aid for Life in conjunction with other medical and first aid professionals. If you have any queries concerning this course, please contact emma@firstaidforlife.org.uk Course contents: Action in an emergency Keep yourself safe Priorities of treatment What to put in your first aid kit Information to give the emergency services The primary survey – how to help in an emergency Danger Response Airway Breathing Unresponsive and breathing Recovery position How to put a baby into the recovery position Choking Burns Fitting/seizures/convulsions Meningitis Head injuries Final lesson