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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GLP: Organization, Roles and Infrastructure for Regulated or Accredited LaboratoriesThis course is intended for professionals and others who are employed in regulated (cGLP and current Good Manufacturing Practice) or accredited (ISO 17025) laboratories, and is intended to form a core … |
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US Pharmaceutical Quality Assurance (QA) Management Professional Certification ProgramThe US Pharmaceutical Quality Assurance Management Professional Certification Program trains workers involved in managing GMP quality. This program is appropriate for those responsible for a broad ran … |
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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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US Medical Device Quality Assurance (QA) Management Professional Certification ProgramUS Medical Device Quality Assurance (QA) Management Professional Certification Program is designed to train those involved in overseeing quality to assure US manufacturing regulations are being follow … |
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Computer Software Assurance (CSA) Professional Certification ProgramThe objectives of this professional certification are to give learners a strong understanding for the principles of Computer Software Assurance (CSA), overview of Computer Systems Validation (CSV) and … |
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GMP: Good Manufacturing Practices – QMS, Premises and PersonnelIn this course we will discuss why we need to adhere to good manufacturing practices from a Quality Management System perspective, we will discuss GMP in relation to production, storage and quality co … |
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GCP: An Introduction to Good Clinical Practices – Part 2 of 3This course explores the relevance of Good Clinical Practices (GCP) in clinical research and trial programs. It covers clinical professional roles, clinical trial methodology, study design, protocol p … |
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GCP: An Introduction to Good Clinical Practices – Part 3 of 3This course explores the relevance of Good Clinical Practices (GCP) in clinical research and trial programs. It covers clinical professional roles, clinical trial methodology, study design, protocol p … |
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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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Commissioning, Qualification & Validation: The Concept of CQV – Part 3This course is part of a complete program on Commissioning, Qualification, and Validation, which includes the following individual courses intended for completion in the order listed, overview and ris … |
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GMP: Good Manufacturing PracticesThis accredited online training course will teach you about Good Manufacturing Practice (cGMP) which is a system for ensuring that products are consistently produced and controlled according to qualit … |
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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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GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 3 of 3)The US Food and Drug Administration (FDA) is responsible for regulating the safety, efficacy, and quality of therapeutic products that save or improve human lives. Firms looking to approve pharmaceuti … |
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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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GLP: An Introduction to Good Laboratory Practices (GLP)By taking this course, you will be able to explain the principles of current good laboratory practices (cGLP) and its importance within a regulated laboratory environment. The benefits of cGLP and how … |
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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: 2 of 4)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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GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 1 of 3)A significant part of the FDA pre-approval process remains inspection actions by the agency to ensure quality, consistency, and safety. Readiness for these inspections is paramount. Having bullet-proo … |
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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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ICH E6(R2) – Clinical Trial Protocol and Protocol Amendment (Chapter 6)Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. |
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GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 2 of 3)Periodically auditing for Good Manufacturing Practice (GMP) observance is a regulatory requirement. This not only involves a methodical understanding of the regulations, but also an insight into how t … |
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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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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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Change Control Professional CertificationThe Change Control Professional Certification will focus on providing an in-depth understanding of performing change control and change management for organizations functioning within the life science … |
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Good Clinical Practice for ProfessionalsGood Clinical Practice for Professionals describes how Good Clinical Practice (GCP) is an international ethical and scientific quality standard provided by International Council for Harmonization (ICH … |
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GCP: An Introduction to Good Clinical Practices – Part 1 of 3Good Clinical Practice (GCP) is an international ethical and scientific quality standard provided by International Council for Harmonization (ICH) for the design, conduct, performance, monitoring, aud … |
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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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ISO 13485:2016 – Product Realization (Chapter 7 – Part B)The primary part of the purchasing requirements for ISO 13485 is to ensure that purchased product conforms to specified purchasing information, which can essentially be broken down into three subsecti … |
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The Lifecycle of a Change Control Program – Phase 2: EvaluateThe process of the change control lifecycle begins with Phase 1 ? Propose, in which a need for change is identified and developed, as shown in Figure 3. Once all of the information is recorded on the … |
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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 … |
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GDocP: How to Manage Deviations in a GMP Environment – Part 1 of 2This course has been designed to explain how to manage deviation in a regulated environment. By taking this course, you will learn how to identify deviations, how to train your personnel on deviation … |
