Millions of people have had their daily routines and work styles impacted. The new way of meeting is online, and honestly, it's been quite chaotic.…Find out more
The FDA has more power to affect regulated companies than almost any other organization, yet many people don’t understand it. Many others ignore it as much as possible. But the FDA affects the job of every person in a medical device or drug company. This course is designed to provide participants with insight into what the regulations are, why they are there, where they fit together, when they apply, and how to interpret them. We will not just discuss Quality Systems and Good Manufacturing Practices, but also submissions, registration, clinical trials, recalls, and adverse event reporting. Each participant will develop a better understanding of the environment in which their company exists and how they can help their company thrive.Find out more
Quality Systems (QS) are sometimes viewed as a necessary evil or belonging only to production and QA personnel. However, effective QS can help a business not only comply, but excel. This course focuses on medical device companies and how to create, implement, and improve QS that match your company. Both FDA QS and ISO QS will be discussed. We will also cover: how different departments are impacted by QS, the biggest pitfalls in establishing and maintaining QS, and how to critically evaluate your QS. There will be group exercises and lots of interaction among participants to provide multiple options. In QS, it is definitely true that one size does not fit all!Find out more
Many organizations, such as FDA, ISO, OSHA, and EPA, can conduct audits or inspections in a biotech company. Most people view these events as scary, but there are ways to make them less difficult. The first method is compliance with the applicable rules. After that, preparation is the key. We will focus on these preparatory techniques, for example, using internal auditing as a tool, developing an inspection procedure, educating employees, and conducting mock inspections. Participants will roll-play being auditors and auditees.Find out more
Building upon Overview of FDA and Quality Systems Overview courses, this course goes beyond the basics and uses interactive exercises to understand and apply current Good Manufacturing Practice (cGMP) regulations for pharmaceutical, biopharmaceutical and medical device industries. This course will dive into the details of 21 CFR Parts 210, 211, & 820, ICHQ7, and the EU GMP guidelines. Participants will benefit from real world examples and lessons learned to use risk-based and scientific principles to ensure product quality throughout the production lifecycle. This course will guide participants through the six system inspection model: Quality Systems, Materials, Packaging and Labeling, Production, Facilities & Equipment, and Laboratory Controls, to provide them with appropriate strategies for ensuring compliance.Find out more
To successfully implement and maintain a quality management system a company must have an Internal Audit process and use trained auditors to perform the audits. Internal auditors are also a key element in quality system improvement. This new course teaches auditing to the ISO 13485:2016 standard and places a strong emphasis on promoting employee participation in the improvement process.Find out more
Data Presentation Design is a half-day seminar and workshop that will improve your ability to create powerful data-focused presentations. Effective data presentations have tremendous power to influence the opinions and decisions of your audience. Whether you are creating presentations for internal team meetings or for large professional or public audiences, this course will teach you how to apply effective data visualization design and provides hands-on training with tools that will help you create engaging and persuasive data presentations.Find out more
Data integrity and good documentation practices (GDP) are essential in providing evidence of a safe and effective product. Learn what the key elements of good documentation practices and data integrity are, how to apply them, and how to proactively ensure your system is compliant.Find out more
Two key goals of a quality management system are to find the root causes of actual and/or potential problems in order to develop and implement permanent solutions that are accepted, efficient, and effective. This 1-day workshop will show how to use root cause analysis tools and methods to find the underlying causes of problems that impact an organizations operations and profitability. You will also learn the methodology to address corrective actions. This workshop is perfect for the novice or for those desiring an invigorating refresher.Find out more
This course provides a structured guide to the process of performing an effective Failure Mode and Effects Analysis for Manufacturing Processes (PFMEA). PFMEA can be performed during development of manufacturing processes to minimize scrap and rework and to minimize the risk of quality “escapes”. It is also a highly effective technique to use in planning under any quality management system standard, such as ISO 9001 and ISO 13485.Find out more
In this “hands on” course participants will design a product utilizing regulations for design control and application of risk management. Participants will learn how to perform risk management, plan design activities, determine design inputs and outputs, verification, validation, how to handle design changes, and the contents and maintenance of a Design History File.Find out more
The ability to perform effectively in teams has become a basic expectation for members of high performance organizations. This workshop provides participants with an understanding of when to use a team, what constitutes an effective team and what their role should be as a member. Participants will learn and practice the interpersonal communication and team process skills that foster the highest creativity and most productive behaviors.Find out more
This course introduces students to the foundations of successful project management, especially in a technology environment. Students will learn key project management concepts, then immediately apply them in a hands-on team simulation.This course approaches project management from the standpoint of managing a single, stand-alone project that is small to medium in size. It takes students through the project life cycle in the same sequence they would face when managing a real project in the workplace.Find out more
By the end of the course, participants will be able to:
- Analyze data using the most appropriate statistical methods and interpret the results.
- Use statistical graphics to display data and the results of data analysis.
- Distinguish between comparison and correlation hypotheses.
- Apply the most appropriate statistical methods to test comparison and correlation hypotheses.
- Use a leading PC-based statistical software program.
Participants in this course will learn the fundamental Lean Six Sigma philosophy and how to apply the tools and methods in their work place on a daily basis. Participants will learn how to identify improvement opportunities and be a valuable resource within Lean Six Sigma project teams led by Green Belts and Black Belts.Find out more
Today’s highly competitive environment leaves no time for trial and error. Design of Experiments (DOE): Introduction provides a structured method for determining the relationship between factors affecting a process and the output of that process. With this information, you can quickly develop the optimum balance between factors leading to dramatic improvements in quality, cost, and productivity. Participants in this 16-hour course will gain a firm understanding of the statistical concepts and basic principles underlying Design of Experiments.Find out more
The key to improving process performance is the ability to understand, control and reduce variation. In this workshop, participants will learn how the monitoring and analysis tools of SPC can be used to achieve that goal. Going beyond the mere mechanics of SPC, this workshop will also guide participants through the steps needed to define a process and determine proper measurement techniques so that the right control chart is used in the right place at the right time.Find out more