This course provides a comprehensive introduction to Computerised System Validation (CSV) for new learners. It covers topics such as categorisation of software and hardware as per GAMP 5, different validation strategies, developing URS, FRS, FAT, SAT, IQ, OQ and PQ, test strategies, validation master plan and validation master report concept, and common questions and answers. It is beneficial for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors, as well as software vendors, auditors, and quality staff involved in GxP applications. This course explores tried, tested, and internationally recognized methods of meeting regulatory requirements for computerized systems in the pharmaceutical industry. Click now to learn more!
eCTD & CTD Preparation & Submission Course
4.1
Udemy3,331 learners
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This eCTD & CTD Preparation & Submission Course is the perfect way to gain a comprehensive understanding of the Electronic Common Technical Document (eCTD) specification. Learners will gain an understanding of the creation of an eCTD submission, and an overview of regional differences in dossiers. Upon completion of the course, learners will receive a certificate of completion and be equipped with the knowledge to pursue job opportunities in Regulatory Affairs, such as Regulatory Affairs Associates, Regulatory Affairs Assistance, Regulatory Affairs Head/Director, and Medical Information. This course is a valuable training and reference tool for those new to the use of the format, and can be of assistance to anyone involved with electronic submissions and navigating changing requirements. Don't miss out on this great opportunity to gain the skills and knowledge needed to pursue a career in Regulatory Affairs.
US Regulatory Strategy for Biologics & Pharmaceutical Drugs
4.8
Udemy361 learners
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This course provides a comprehensive overview of US Food & Drug Administration (FDA) regulations for biologics and pharmaceutical drugs. It is beneficial for scientists, physicians, entrepreneurs, public health professionals, industry analysts, consultants, and biomedical students interested in the biotechnology and pharmaceutical industry. Learners will gain an understanding of the importance of FDA regulations for public health, and how to navigate through the FDA regulations to market a biologic or pharmaceutical. They will also develop their ability to conduct regulatory intelligence and develop a regulatory strategic plan. This course is a great opportunity to gain knowledge of the drug development process and the key regulatory steps toward FDA approval.
Master pharmaceutical quality management system
3.8
Udemy370 learners
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This course provides a comprehensive overview of the Quality Management System (QMS) in the pharmaceutical industry. Learners will gain an understanding of the three levels of quality, the role of management in the QMS, the objectives of the QMS, and how the elements of the QMS are integrated. They will also learn about the meaning and application of the QMS in the pharmaceutical industry, the quality standards and pharmacopeias behind it, the ISO, GMP, and GXP, and the importance of documentation. Finally, learners will gain an understanding of personnel training and process validation. Master pharmaceutical quality management system is the perfect course for those who want to gain an in-depth understanding of the QMS in the pharmaceutical industry.
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