InTouch
July / August 2017

ISPE Online Training - Study Anytime, Anywhere

Article - ISPE Pharmaceutical Engineering

ISPE’s online training courses let you take ISPE’s signature training—the type usually delivered over two to three days in a distant classroom—from your home or office. Courses leverage the expertise of our global membership to provide real-world solutions to help companies improve product quality, lower production costs, and increase process efficiency while understanding regulatory requirements. Our courses include assessments, a downloadable course presentation for note-taking, and links to regulatory information. Participants earn ISPE CEU’s upon successful completion.

Visit Expanded Online Training and select “Demo” to see a preview of each course.

 

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.

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.

Basic Principles of Computerized Systems Compliance: Apply the GAMP® 5 Guide—A Risk-Based Approach to Compliant GxP Computerized Systems

This course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. 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.

Immediately apply the course learning objectives with an electronic download of the GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems Guide.

Biotechnology Basics: Fundamental Principles of the Biotechnology Industry

Explore the history of the biotechnology industry and will learn the fundamental concepts of biotechnology science and learn basic terminology and how it is applied in the industry. The course will 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

Calibration is an essential element in ensuring compliance in the pharmaceutical and associated regulated life science industries. To ensure success, calibration should be managed effectively, by appropriately qualified and competent personnel. 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.

Immediately apply the course learning objectives with an electronic download of the GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management

Cleaning Fundamentals for the Pharmaceutical Industry

Clean-in-place design integration and cleaning chemical selection are vital components of every pharmaceutical manufacturing process; indeed, all pharmaceutical companies employ some type of cleaning application every day. As a result, FDA inspections of cleaning processes have been occurring with greater frequency in today’s highly regulated manufacturing environment. To achieve effective and easily validated cleaning methods is to gain a thorough understanding of cleaning methods. 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. Additional topics covered include a CIP technology review including examples of various pharmaceutical processes that illustrate how CIP technologies and hygienic design can improve cleanability. Other topics for discussion include CIP spray device selection criteria and dynamics of integrating CIP process piping into a pharmaceutical process.

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, interactive response technology, and 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.

Complying with Part 11: Risk Management

This course provides 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.

Containment Fundamentals

This course will focus on airborne contaminants and begin by discussing the definition, history, and rationale for the containment of compounds and processes. An exploration of different containment philosophies, methods of source containment, and a hierarchy of containment approaches will also be covered. After establishing the need for containment and presenting alternative methods, the course will focus on the importance of fully understanding a manufacturing process in all its dimensions (physical hardware, remedial containment provisions, facility considerations, operator interface, cleaning and decontamination, and other aspects) before optimal containment solutions may be developed and incorporated into the manufacturing processes. This course will also address plant operations ranging from pilot scale to commercial manufacturing.

Immediately apply the course learning objectives with an electronic download of the ISPE GPG: Good Engineering Practice.

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 comply with applicable regulations. GEP underpins activities of daily operations and forward planning of a pharmaceutical business; the adoption of GEP methodology can lead to a balance of expenditure and activity. The scope of GEP covers the complete life cycle of engineering from concept to retirement and provides a foundation required across the pharmaceutical industry upon which other areas, such as GxP, build. In addition, GEP documentation can be leveraged to support verification work. This course also utilizes benchmarking tools from company practices against what is considered industry good practice.

GMP Auditing for the Pharmaceutical Industry

Auditing is a critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company’s compliance with pharmaceutical US FDA GMP regulations and other quality standards like ICH Q10. 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. The course includes a supplemental module that provides guidance in preparing for regulatory GMP inspections and is designed to provide broad fundamental industry knowledge through a customized learning experience for individuals that want to expand their cGMP knowledge.

Immediately apply the course learning objectives with an electronic download of the ISPE GPG: Good Engineering Practice.

Maintenance: Reliability, Engineering, and Asset Management

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. course leverages the content and templates from the ISPE Good Practice Guide: Maintenance to provide the tools for the development, implementation, and execution of cost-effective compliance for new or existing maintenance programs in a pharmaceutical manufacturing environment. In addition, the course promotes the concept that maintenance performed on any physical asset should only be performed if it addresses a potential failure mode. The course defines roles and responsibilities across cross-functional areas and recommends a systematic approach aimed at continuous improvement of maintenance operations.

Immediately apply the course learning objectives with an electronic download of the ISPE Good Practice Guide: Maintenance.

Operationalizing a Quality Metrics Program: Critical Success Factors

Metrics programs should be a core part of a company’s Pharmaceutical Quality System. This online course is designed for every person who is involved in a metrics program, including operators and quality control personnel who contribute to generating the raw data, through to those involved in collecting, submitting and, most importantly, analyzing the data, drawing conclusions, and taking relevant and necessary actions to implement continual improvement projects.

Following the passage of the US FDA Safety and Innovation Act (FDASIA) of 2012, the FDA is considering the utilization of quality metrics as an input to its inspection models to determine inspection schedules for manufacturers, as well as to assist in the prediction of possible drug shortages. Metric data as well as other information available to the agency may assist with amendment of postmarket change reporting requirements and restructure the frequency and format of inspection. To that end, after receiving

input from industry on which metrics manufacturers use and find effective to measure quality performance the FDA issued two draft guidances, one in 2015 and a revision in 2016.

This online course teaches the role of quality metrics within a company’s key performance indicator 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 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.

The course includes an electronic download of the ISPE Quality Metrics Initiative Wave 1 and Wave 2 Reports.

Operations Management

For the purposes of this eLearning course, operations are defined as the transformative process within a series of activities, along a value chain extending from supplier to customer. Operations management designs, operates, and improves supply chain systems for getting work done. The ISPE Good Practice Guide: Operations Management aims to provide the pharmaceutical industry with a knowledge base to promote the use of best practices and operational excellence within pharmaceutical operations management. Addressing operations along the supply chain, from the selection of raw materials through to the distribution of final product. For this training, operations are defined as the transformative process within a series of activities, along a value chain extending from supplier to customer. Operations Management designs, operates, and improves supply chain systems for getting work done.

Immediately apply the course learning objectives with an electronic download of the ISPE Good Practice Guide: Operations Management.

ISPE’s eLearning offerings include online courses and webinars to help you expand your skills and knowledge from the comfort of your desk (www.ispe.org/elearning):

  • General Industry Knowledge: These courses offer general industry knowledge while providing an industry overview, historical background and the basic building blocks to get you started and understand more advanced and specific industry topics 
  • Fundamental Industry Knowledge Courses: ISPE’s prerecorded courses, which were developed and reviewed by expert instructors and international regulatory advisors 
  • GMP Courses: Learn the U.S. Food and Drug Administration’s Systems-based GMP inspection approach
  • Webinars: Prerecorded webinars for over 20 topic-specific areas