These online training courses deliver the intensity of face- to-face training, at your keyboard.
Each interactive course includes:
- A downloadable presentation for note-taking.
- Engaging graphics.
- Reference materials and links to regulatory information.
- Assessments to measure your comprehension.
- The ability to start and stop at any time, beginning where you left off.
CEUs are provided once you achieve an 80% passing grade and complete the evaluation.
Airflow pattern visualization provides a visual record of actual airflow patterns in a pharmaceutical facility. It is currently the most widely accepted method of demonstrating that airflow patterns in critical processing areas meet regulatory expectations. In addition, airflow pattern visualization allows multiple functional organizations to discover the effectiveness and significance of the airflow design and functionality, especially in critical areas. The course provides a unique opportunity to explore the requirements for airflow pattern visualization and to see different video examples of actual airflow pattern visualization results. The course provides a comparison of different types of airflow patterns, but focuses primarily on unidirectional airflow patterns in critical areas (ISO 5). The student will also learn how to avoid some of the problems that can occur when creating the visual recording how the results of airflow pattern visualization can be evaluated objectively.
Basic Principles of Computerized Systems Compliance: Applying the GAMP5® Guide: A Risk-Based Approach to Compliant GxP Computerized Systems
GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.
This course will provide an overview of clean-in-place (CIP) systems including design, integration, and selection of cleaning chemicals. Participants will discuss engineering concepts, principles, and integration of CIP systems, clean-out-of-place (COP) systems, or immersion parts washers. While there will be some discussion of manual cleaning practices, cleaning principles will be primarily introduced as they relate to the dynamics of CIP and COP technologies, with an emphasis on selecting the right cleaning chemistries for specific soil residues.to enable widespread adaptation and encourage innovation to minimize the total cost of asset ownership.
This course provides checklists, templates, flowcharts and example documents, that are currently in use for decommissioning of pharmaceutical equipment and facilities in the USA and Europe. Methods and systems that would satisfy the requirements of Regulatory Authorities based on practices that have been developed in the US and Europe will also be highlighted.
This course covers pharmaceutical facilities for the manufacture of OSD forms, including tablets, capsules, and general powders. It also may be applied to pilot and clinical supply facilities. The eLearning course is not intended to address the manufacture of dietary supplements, excipients, sterile products, topicals, oral liquids, or aerosols. Wherever applicable, references are provided to existing Baseline® Guides for further detail on specific systems or operations.