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.
This course provides you with the basic competencies required to effectively perform the auditor’s assigned responsibilities by defining audits, explaining why audits are carried out, discussing the types and levels of audits and discussing what is required for preparing to audit medical devices. Throughout the course we will explore auditor traits and skills, describe strategies for asking questions and good listening skills and review the importance of body language on the audit process. We will also review the audit timetable and provide a general approach for conducting the audit and the importance of keeping thorough records, clear and concise notes and provide auditing tips and resources. Additional content will focus on providing guidance for exit meeting preparation and managing findings including the elements of a good report, follow-up activities and problem solving tools.
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.
Identify basic process science and unit operations for the manufacture of products and will describe the regulatory foundation that makes biological products different from traditional pharmaceutical products.
Calibration Management: A Robust, Cost effective Approach Using the GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management
This online course provides guidance in setting up a calibration management system, which will give a structured approach to instrument risk assessment, calibration program management, documentation, and corrective actions, essential to regulatory compliance. The course will describe a system of calibration management, which defines what needs to be done, when, by whom, and why, as well as identify regulatory requirements and business benefits.
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.
In this course, you will receive a thorough overview of the clinical supply chain from beginning to end, including: designing appropriate packaging and labeling to match the study design, creating a plan of action to prepare the Clinical Trial Material (CTM) and how to implement the plan and troubleshoot. The course also covers the logistics of distribution of the CTM to the clinical sites globally. Important tools, such as outsourcing vendors for packaging and labeling and Interactive Response Technology along with Randomizations will be covered to ensure familiarity with all the necessary concepts. Additional content will focus on the roles of the Clinical Project Team and how they interact with the CTM group and the regulatory framework needed to stay abreast of regulatory changes.
This course will give participants a practical introduction to the 21 CFR Part 11 regulations, which affects many aspects of computerized systems in the pharmaceutical industry. The course will present an overview of Part 11 expectations including FDA's current interpretation.This will be followed by a detailed analysis of Part 11 requirements, a discussion of electronic records and signatures, and key industry issues. The recently revised EU GMP Annex 11 and Chapter 4 (which have been adopted for international use by PIC/S) are also covered. As well as the European and international expectations for electronic records and signatures, the general requirements for computer systems validation and compliance as described in Annex 11 will be explained in detail.
Exploration of different containment philosophies, methods of source containment, and a hierarchy of containment approaches while fully understand and incorporate manufacturing process.
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.
Effective project progress, monitoring, and control are not regulatory issues, but are necessary for the efficient operation of a company and part of Good Engineering Practice (GEP). This course considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEPs consisting of proven and accepted engineering methods, procedures, and practices that provide appropriate, cost-effective, and well-documented solutions to meet user-requirements and compliance with applicable regulations.
Auditing for GMP is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities and contribute to the improvement of auditor performance within a regulated industry.
This presentation discusses the challenges and benefits of applying a science and risk based commissioning and qualification approach within a contract manufacturing organization, presented by Frank van der Steen, SynCo Bio partners. Do you have a framework for a risk-based approach for maintenance systems or component best practices?
Maintenance programs have long been recognized as critical to the success of the operations they support. Maintenance has the potential to affect both the quality of products and the compliance of pharmaceutical processes. This course provides a practical and consistent interpretation of the necessary elements of a pharmaceutical maintenance program, while offering maximum flexibility to enable widespread adaptation and encourage innovation to minimize the total cost of asset ownership.
This online course teaches the role of quality metrics within a company's Key Performance Indicator (KPI) program using the extensive experience ISPE gained from two extensive pilot programs undertaken in collaboration with McKinsey and Company and with participation from 28 companies and 83 sites. The participating companies and sites represented a wide range of technologies and included contract manufacturing organizations (CMOs) and laboratories, and drug substance manufacturing sites. ISPE used this vast breadth of experience and engagement with companies in regard to potential regulatory metrics - what they might be, how they could be collected and used - to develop this very instructive webinar.
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.