Search Courses and Programs
Use this form to search course ID, name, description, outline, and objectives. This is a multiple word search. Each word must be 3 characters or more (e.g., GMP, GCP, Clinical, etc). Shorter words and any special characters will be ignored. You can search courses for things such as GMP001S1, GAMP, Pharmacovigilance, Quality Assurance, ALCOA, Validation, Clinical Trials, CFR Part 820, Cleaning Validation, or Drug Safety.
Searching courses for: validation
Validation: Equipment Cleaning ValidationThis online program offers an introduction to the international principles and regulations behind equipment cleaning validation. Manufacturers of medicines and healthcare products must establish, vali … |
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Validation: Introduction to ValidationValidation of equipment, services, systems and processes is vitally important in the medicines and healthcare products industries. Regulatory authorities require documented evidence that manufacturing … |
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Validation: Plans and DocumentationEssential to validation is the provision of documented evidence verifying that manufacturing processes will consistently result in products meeting predetermined quality standards. This program descri … |
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Pharmaceutical Validation Management Professional Certification ProgramThe Pharmaceutical Validation Management Professional Certification Program includes an introduction to the principles behind the international regulations. These regulations are designed to assure ef … |
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Validation: Computer System Validation (Part 2 of 2) (Implementation)This online training program builds upon Computer Systems Validation Part l (VAL09). It offers an introduction to computer systems validation as required by GxP regulations. This course describes the … |
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Validation: Computer System Validation (Part 1 of 2) (Planning)This online program offers an introduction to the international principles and regulations behind computer systems validation. Course objectives include the following: to offer an understanding the co … |
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Computer System Validation for ProfessionalsComputer System Validation for Professionals program includes an introduction to the international principles and regulations behind effective validation and qualification. The program offers an intro … |
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CSA: Computer Software AssuranceThe FDA’s approach to Computer System Assurance (CSA) represents a modernized perspective on computer system validation (CSV), aiming to ensure that systems used in the life sciences industry are reli … |
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Validation: Commissioning and Installation Qualification (IQ)This online program offers an introduction to the international principles and regulations behind commissioning and installation qualification (IQ). Before equipment can be used routinely in productio … |
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Validation: Operational and Performance Qualification (OQ/PQ)This program offers an introduction to operational qualification (OQ) and performance qualification (PQ). Having undergone Installation Qualification (IQ), before equipment can be used routinely in pr … |
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Drug Safety: Signal Detection and Management in PharmacovigilanceThe fundamental aim of drug safety assessment is to establish what adverse reactions may be caused by a medicinal product. Factors such as seriousness, severity, and frequency of reactions are then ta … |
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cGMP: Quality Assurance and Quality Control (QA/QC)This course emphasizes quality assurance and quality control, with respect to good manufacturing practices. Participants explore GMPs as they apply to quality testing, management, manufacturing, and t … |
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Drug Safety and Pharmacovigilance Professional Certification ProgramThis training program provides a comprehensive overview of the requirements and concepts necessary to attain a strong understanding of drug safety and pharmacovigilance.Drug safety monitoring and risk … |
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Clinical Trial eSystems Inspection ReadinessThe use of electronic systems to support critical endpoint and safety data continues to increase. A clinical eSystem is an electronic system used to support the clinical trial, such as to collect, han … |
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Drug Safety: Good Pharmacoepidemiology PracticePharmacoepidemiology 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 … |
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cGMP: Cleaning and SanitationThis Good Manufacturing Practice (GMP) in Cleaning and Sanitation training program offers a comprehensive overview and a solid introduction to cleaning and sanitation, as it relates to the regulator o … |
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cGMP: Introduction to Good Manufacturing Practice for Medicinal ProductsGood Manufacturing Practice (GMP) is a set of rules for medicines manufacturers to follow so that their products are safe, effective, and of good quality. The rules may be written into law or set out … |
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cGMP: The Principles of GMP (Fundamentals)This is a micro learning course: A 30-minute course designed to introduce new employees or reinforce seasoned employees on GMP guidelines. It is used to encourage awareness of the importance of follow … |
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Regulatory Affairs: Orphan Drug Application – EU and USMedicines for the prevention, diagnosis, or treatment of rare diseases have become known as ‘orphan drugs’ because they are commercially unattractive. Development of such products is successfully enco … |
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Regulatory Affairs: Registration of Drugs Based on Monoclonal AntibodiesThis course addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of … |
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Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)Part 11 of Title 21 of the US Code of Federal Regulations (21CFR11) sets out requirements that computer systems must meet to satisfy the Food and Drug Administration (FDA), and to assure that electron … |