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.
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Searching courses for: Quality Assurance
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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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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 pharmaceutical, medical device, … |
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Introduction to Good Laboratory Practice (GLP)In this Good Laboratory Practice (GLP) compliance training course, we will delve into the history, regulatory agencies, and fundamental principles of GLP. Whether you are a scientist, researcher, memb … |
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cGMP: Good Manufacturing Practice in Packaging Medicinal ProductsPackaging operations constitute the last manufacturing step before release of a product to the market. They convert bulk product to the final product.Packaging for medicinal products is subject to Goo … |
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Good Laboratory Practice (GLP)The purpose of GLP is to provide assurance of the quality and reliability of nonclinical study data. GLP covers the planning, performance, monitoring, recording and reporting of studies. Regulatory au … |
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cGMP: Good Documentation Practice (GDocP)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 … |
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Clinical Trials: Preparing for an Audit or InspectionGood Clinical Practice (GCP) inspections and audits are carried out to provide assurance that: the rights, safety and welfare of clinical trial subjects are protected; the data that constitute the res … |
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Current Good Manufacturing Practice (cGMP) Professional Certification ProgramThis cGMP Professional Certification Program is an excellent choice for gaining a strong and comprehensive understanding of GMP for pharmaceuticals. The program describes how GMP applies, globally, to … |
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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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Clinical Research Coordinator (CRC) Professional Certification ProgramThe Clinical Research Coordinator (CRC) Professional Certification Program provides a strong foundational understanding of clinical trails and all stakeholder responsibilities. This program emphasizes … |
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Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the USThis course outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing ap … |
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The Biologics License Application (BLA) for Marketing Approval in the USABiological products have come to dominate the market for medicines in recent decades. To introduce a biological product into interstate commerce in the USA, the sponsor of the product must gain FDA ap … |
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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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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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cGMP: Good Manufacturing Practice in Processing Medicinal ProductsOperations 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 … |
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Clinical Research Associate (CRA) Professional Certification ProgramGCP, or Good Clinical Practice, refers to a set of scientific and ethical quality standards for reporting, recording, conducting, and designing trials that involve human subjects. GCP compliance ensur … |
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Regulatory Affairs: Essentials of Monoclonal AntibodiesMonoclonal antibodies (mAbs for short) are the leading products of biotechnology. Drugs based on mAbs dominate the list of top-selling medicines worldwide. In addition, mAbs have many uses in medical … |
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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 … |
