Pharmacoepidemiology is the study of the use and effects of drugs in large numbers of people. It provides a bridge between clinical pharmacology and epidemiology. The increasing demand for real-world evidence of the safety, efficacy and utility of medicinal products has focused greater attention on pharmacoepidemiological research. This module will help those who plan and conduct such research, and analyse and report the findings, to follow good practice.
Cleaning and sanitation of premises and equipment are essential to efforts to prevent contamination of product, and they need to be done in compliance with Good Manufacturing Practice (GMP) regulatory requirements. This module shows why it is so important to do a good job, what to consider before and during each job, and how best to go about the work.
Packaging for medicinal products is subject to Good Manufacturing Practice rules similar to those for the products themselves. In this module we describe the functions that packaging must fulfil and the quality controls that are applied to packaging materials and operations. We set out the requirements for control of printed materials. We describe preparation, in-process control, and completion of a packaging run. Finally, we explain how to carry out reconciliation of packaging materials.
Good Manufacturing Practice (GMP) for medicinal products relies on documentation. Good Documentation Practice (GDocP) is that part of GMP that applies to the creation, maintenance, use, and retention of documents to provide assurance of the quality of products.
A company’s Corrective and Preventive Action (CAPA ) system establishes how personnel should deal with manufacturing problems that have occurred or that may occur if not prevented. This module explains the principles of corrective and preventive action and describes typical CAPA procedure. It goes on to introduce root cause analysis and outline the role of progress tracking, escalating, and trending of CAPA procedures.
This module will introduce you to monoclonal antibodies, explaining how they work, how they are made, and the many uses to which they are put.
Operations in the dispensary and on processing lines are at the heart of medicinal product manufacturing. This module describes how to carry out such operations in compliance with the requirements of Good Manufacturing Practice.
An Urgent Safety Restriction (USR) is a regulatory action taken, in response to a safety signal, to make an interim change to the terms of the marketing authorisation for a medicinal product in Europe. This module describes the principles and procedures for USRs.
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.
Overview of Eating Psychology Course Any data concerning a person's physical or emotional health is considered personal and sensitive. Therefore, the General Data Protection Regulation (GDPR) was introduced for data protection. This Healthcare GDPR Basics Course will give you a solid understanding of GDPR and its role and importance in healthcare. Through this Healthcare GDPR Basics Course, you'll gain valuable insights into the essential GDPR principles for healthcare data. The course will teach you about data governance frameworks, data protection policies implementation, data subject rights and balancing rights and obligations. In addition, it will take you through data breach risks in healthcare GDPR and security measures. The course also covers transferring health data under GDPR and safeguarding patient privacy in global healthcare initiatives. Course Preview Learning Outcomes Understand how GDPR can help protect health data Know what are the obligations under GDPR Discover the cybersecurity threats and prevention measures Identify the legal frameworks for international collaboration Learn the strategies to protect health data and ensure data integrity Why Take This Course From John Academy? Affordable, well-structured and high-quality e-learning study materials Meticulously crafted engaging and informative tutorial videos and materials Efficient exam systems for the assessment and instant result Earn UK & internationally recognised accredited qualification Easily access the course content on mobile, tablet, or desktop from anywhere, anytime Excellent career advancement opportunities Get 24/7 student support via email Who Should Take this Healthcare GDPR Basics Course? Whether you're an existing practitioner or an aspiring professional, this course is an ideal training opportunity. It will elevate your expertise and boost your CV with key skills and a recognised qualification attesting to your knowledge. Are There Any Entry Requirements? This Healthcare GDPR Basics Course is available to all learners of all academic backgrounds. But learners should be aged 16 or over to undertake the qualification. And a good understanding of the English language, numeracy, and ICT will be helpful. Certificate of Achievement After completing this course successfully, you will be able to obtain an Accredited Certificate of Achievement. Certificates & Transcripts can be obtained either in Hardcopy at £14.99 or in PDF format at £11.99. Career Pathâ Healthcare GDPR Basics Course provides essential skills that will make you more effective in your role. It would be beneficial for any related profession in the industry, such as: Compliance Officer Data Protection Officer (DPO) Healthcare Administrator Healthcare Consultant Legal Professional Module 1: Introduction to Healthcare GDPR Introduction to Healthcare GDPR 00:17:00 Module 2: Data Governance in Healthcare Data Governance in Healthcare 00:18:00 Module 3: Healthcare Data Subject Rights and Obligations Healthcare Data Subject Rights and Obligations 00:19:00 Module 4: Protecting Health Data Protecting Health Data 00:17:00 Module 5: GDPR Obligations and Sensitive Data GDPR Obligations and Sensitive Data 00:19:00 Module 6: Transferring Health Data Transferring Health Data 00:19:00 Module 7: Consent and Lawful Bases for Healthcare Data Processing Consent and Lawful Bases for Healthcare Data Processing 00:18:00 Module 8: Rights of Data Subjects Rights of Data Subjects 00:19:00 Module 9: Safeguarding Healthcare Data Safeguarding Healthcare Data 00:19:00 Module 10: Protecting Health Data in the Modern Age Protecting Health Data in the Modern Age 00:18:00 Module 11: Cross-Border Health Data Cross-Border Health Data 00:18:00 Module 12: Medical Research Medical Research 00:18:00 Certificate and Transcript Order Your Certificates and Transcripts 00:00:00