Expanded Online Training Courses

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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.

How to Register ( 1 MB)

Demo the AFPV Course Now!

Airflow Pattern Visualization (AFPV)

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.

Demo the AFPV Course Now!

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Auditing for Medical Devices

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.

Demo the Auditing for Medical Devices Course Now!

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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.

Demo the GAMP Course Now!

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Biotechnology Basics

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.

Demo the Biotechnology Course Now!

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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.

Demo the Calibration Management Course Now!

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Cleaning Fundamentals for the Pharmaceutical Industry

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.

Demo the Cleaning Fundamentals Course Now!

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Clinical Trial Materials: Applying Production, Quality Assurance and Packaging Processes

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.

Demo the Clinical Trial Materials Course Now!

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Complying with Part 11 - Risk Management: Applying the GAMP® Good Practice Guide Electronic Records and Signatures Principles

Applying the GAMP Good Practice Guide: A Risk Based Approach to Compliant Electronic Records and Signatures as a resource, 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.

Demo the GAMP Part 11 Course Now!

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Containment Fundamentals

Exploration of different containment philosophies, methods of source containment, and a hierarchy of containment approaches while fully understand and incorporate manufacturing process.

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Demo the GEP Course Now!

GEP: Risk and Cost Management

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.

Demo the GEP Course Now!

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GMP Auditing for the Pharmaceutical Industry

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.

Demo the GMP Course Now! Try Module 1 for free!

Demo the Maintenance Course Now!

Maintenance: Reliability, Engineering and Asset Management

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.

Demo the GMP Course Now!

Sponsorship Opportunities

For more information on ISPE sponsorship opportunities, please contact:

Christy Troiano, Director, Sales
Telephone: +1-301-364-9212
Email: ctroiano@ispe.org

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