This self-paced learning course provides comprehensive instruction on Sterile Manufacturing Practices in pharmaceutical manufacturing.   This course utilizes real-world scenarios, embedded video and audio content to instruct on the practical application of these requirements. Engaging knowledge checks are provided throughout each module, and the course concludes with a final competency assessment. The program is presented in three modules: - approximate course completion time = *4.5 hours. Once you finish the first module, you will automatically be able to begin the next module.   Module 1 - Introductory Topics – approximately 1.5 hour Provides key information relevant to microorganisms and sources of contamination, particularly in manufacturing areas.  At the end of this module, you will be able to: Explain the basics of microbiology Recognize what constitutes a sterile versus non-sterile product Define Aseptic environment Identify how specific organisms can cause contamination Recognize how Mother Nature is a potential contamination source Identify other potential sources in a manufacturing area   Module 2 - Intermediate Topics – approximately 2 hours Provides common terminology used in sterile manufacturing procedures such as: Clean Room, Unidirectional air, First air, Restricted access barriers (RABS) versus isolators, autoclave cycle, and isolators.  At the end of this module, you will be able to explain: HVAC Requirements Clean Room requirements and clean room preparation Personnel and material flow Primary packing components Sterilization with both heat and radiation Depyrogneation Steam in place (SIP) Terminal Sterilization Sterile Filtration   Module 3 - Advanced Topics – approximately 2 hours Provides information related to the practical application of Sterile Manufacturing Practices.  At the end of this program, you will be able to: Describe routes of administration and associated patients Successfully complete the gowning process Explain the interrelation between materials, people, equipment and environment for aseptic processing Be aware of the critical controls in place Identify specialized filling technologies Providing an overview of lyophilization Explain container-closure integrity (CCI) Perform visual inspection Explain clean room monitoring *Completion times included are approximate and based on the amount of content included in each section. Content is self-paced, driven by the learner. Read more

This course includes six modules. The first five modules cover the U.S. Quality Systems Regulation (21 CFR 820) and the sixth module covers the Regulation of Combination Products (21 CFR Part 4). Each module includes an approximately one-hour video instructional presentation by Kim Trautman, Executive Vice President, Medical Device International Services at NSF International, followed by an assessment on the information covered in the video. Read more

Medical device regulators from around the world have recognized the importance of top management’s commitment to quality as essential to establishing and maintaining an effective quality management system.  Top management of medical device manufacturers have been held legally responsible for quality management system failures.  Top management is not simply the most responsible corporate officials, but also those responsible for site-specific activities throughout the organization.  When considering action, regulatory authorities may use a “wide net” when identifying top management.  It is essential that top management of all levels of an organization understand its obligations to quality.  Cognizant of the value of top management’s time, this approximately one-and-a-half-hour course was designed to efficiently focus on top management obligations relative to FDA’s Quality System Regulation and ISO 13485:2016.  This course does not simply focus on the requirements of the regulation and standard but provides insight into the expectations of the framers of those documents through discussions of the preamble to the quality system regulation, and TC 210 guidance relative to ISO 13485:2016.  These discussions and supporting examples provide valuable insight into how to comply with the cited regulation and standard requirements.   Read more

This course provides a comprehensive overview of the United States medical device regulatory framework, including both pre-market and post-market requirements. This two-hour overview covers the changes and key aspects of the regulations as well as instruction on the way the United States is utilizing MDSAP. Read more

The pre-submission or Q-Sub program is a voluntary mechanism to get FDA’s feedback on specific questions necessary to guide product development and/or application preparation. This course provides instruction critical to prepare for a successful meeting with the FDA. Read more

In this approximately 30-minute self-paced course, you will be introduced to the importance of writing effective nonconformity statements during audits of medical device manufacturer quality management systems. Learners will identify the fundamentals of medical device QMS auditing that influence the writing of effective nonconformity statements. Learners will recognize when to communicate nonconformities during an audit and identify tools and tips for writing effective nonconformity statements. Learners will also demonstrate how to assess nonconformity statements to confirm they are free from opinion and bias. Read more