This course provides a comprehensive overview of Part 11 Compliance for Computerised Systems. It covers USFDA 21 CFR Part 11, EUGMP Annex 11, and Data Integrity requirements. Through discussion and learning videos, you will learn how to design systems and processes to ensure compliance, audit preparedness, and common errors to avoid. This course is essential for any pharmaceutical company looking to ensure their computerised systems are Part 11 compliant.
Data Integrity requirements for Pharmaceuticals
3.6
Udemy164 learners
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This course provides a comprehensive understanding of the data integrity requirements for pharmaceuticals. It covers topics such as GMP principles, FDA and European inspector citations, US Warning Letters and EU Non-Compliance Reports, and international authority guidelines. Learners will gain an understanding of the data integrity requirements of a GMP regulated laboratory in pharmaceutical organisations and contract labs, and how laboratory personnel can ensure compliance and be able to defend their positions. The course also covers basics in data integrity and audit trail review, as well as the differences between good documentation Practices requirements and data integrity requirements. Specialised sessions focus on data integrity requirements for analytical laboratories and Microbiology laboratories. Join this course to gain a comprehensive understanding of data integrity requirements for pharmaceuticals.
Computer Aided Drug Design (CADD) from A to Z
4.2
Udemy117 learners
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This course provides a comprehensive overview of Computer Aided Drug Design (CADD) from A to Z. It is suitable for anyone who wants to learn the basics and concepts of drug discovery and design drugs from scratch. Learners will gain an understanding of the relationships between physico-chemical properties of drugs and their biological activities, as well as the types of interactions between drugs and receptors. They will also be familiar with modern techniques such as computer-based methods of quantitative structural activity relationship QSAR and molecular graphics. This course covers all aspects of drug discovery, from sources of lead compound to drug latentiation (prodrug), and is perfect for anyone looking to gain a comprehensive understanding of CADD.
The Pharmaceutical R&D Process in Healthcare
4.5
Udemy1,264 learners
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This course provides an in-depth understanding of the pharmaceutical R&D process in healthcare. Through lectures, quizzes, activities, and opinion questions, learners will gain an understanding of how drugs are discovered, developed, and marketed, and the role of the FDA. It is designed for anyone considering a career in the pharmaceutical industry or anyone who would like to know more about the process. Learners will be able to evaluate job descriptions, select the appropriate career training courses and conferences, and confidently discuss opportunities with career counselors, recruiters, and people working in the pharmaceutical industry. This course is perfect for those looking to gain a comprehensive understanding of the pharmaceutical R&D process in healthcare.
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