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.
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.
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.
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.
his module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the MRP.
This module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the DCP.
The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and verified from source documents, and the conduct of the trial complies with the study protocol, Good Clinical Practice and regulatory requirements. In this module we describe how a Clinical Research Associate (CRA) monitors an ongoing trial to its conclusion.
OET (Occupational English Test) is designed to meet the specific English language needs of the healthcare sector. It assesses the language proficiency of healthcare professionals who wish to practice in an English-speaking environment. All four language skills are assessed, with Writing and Speaking tests available in 12 different areas of healthcare. All candidates sit the same Reading and Listening tests. OET is accepted as proof of English proficiency in the UK, Ireland, Australia, New Zealand, Dubai, Namibia and Singapore for registration in 12 healthcare professions.
Investment Banking: LBO, IPO and M&A Online Course This Investment Banking Training: LBO, IPO and M&A course gives you a clear and practical introduction to the world of investment banking. You will learn how investment banks operate, how they value companies, and how major financial deals like leveraged buyouts, initial public offerings and mergers and acquisitions work. The course explains these processes in a simple, step-by-step way, helping you build the skills to succeed in corporate finance and deal-making. Course Curriculum Module 1: Working in Different Healthcare Settings Module 2: Understanding Legal, Professional Standards of Practice and Ethical Aspects of Health Care – Part 1 Module 3: Understanding Legal, Professional Standards of Practice and Ethical Aspects of Health Care – Part 2 Module 4: Maintaining Medical Records Module 5: Confidentiality in a Medical Environment Module 6: Health and Safety Responsibilities Module 7: Hygiene in Nursing Module 8: Infection Control Module 9: Mobility and Immobility Issues of Patients in Nursing Module 10: Rights and Responsibilities as a Health and Social Care Worker Module 11: Role as a Caregiver and Healthcare Professional Module 12: Providing Care or Treatment to People Who Lack Capacity Module 13: Managing Service Delivery in Health and Social Care Module 14: Medical Jargon and Terminology Module 15: Effects of Covid-19 on Human Life Module 16: Preventions and Social Measures to Be Taken Module 17: Information Technology in Health Care Module 18: Artificial Intelligence, Data Science and Technological Solutions Against Covid-19 (Learn more about this online course)