Pharma companies use Learning Management Systems (LMS) as vital tool for demonstrating to regulatory authorities that they are maintaining and ensuring their staff training efforts are up-to-date. Most LMS systems frequently claim unlimited functionality and scalability but have limitations that companies should be aware of in order for them to overcome and be able to […]

This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course […]

How can this new internal inspection tool – the Layered Process Audit (LPA) – be used to assist in FDA regulatory compliance, and in meeting requirements for an annual internal cGMP system audit / inspection. Each year companies are to perform a complete review /inspection / audit of their quality management system and its ability […]

This 60 minutes webinar will give a better understanding of the relationship between compliance, documentation, and training. It will provide participants with the ability to effectively meet regulatory requirements, properly integrate training into their quality system, and develop effective compliance documentation that meets both regulatory and training purposes. There is an increasing trend for regulatory […]

Despite best efforts, serious quality issues resulting in a recall can occur. Medical Device companies need to be prepared in advance to handle the difficult situation. This 6-hour virtual seminar will prepare you to understand the signals that trigger a need to recall, the investigation and other actions required, taking corrective and preventive action, and […]

This 3-session seminar will cover: Process capability and process performance, which reflect the ability of a process to meet specifications. A Six Sigma process will, when centered on the nominal, have only two nonconformances or defects per billion opportunities. (3.4 defects per million opportunities assumes a major process shift of 1.5 standard deviations.) Statistical process […]

Standard Operating Procedures (SOPs) are necessary to demonstrate compliance with regulations and operational practices. It also serves as a documented roadmap which ensures consistency. This is integral to a strong quality system. If you want to improve SOPs writing and training materials that create more effective training as well as help in the reduction of […]

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). This webinar will help you […]

In this regulatory inspection webinar attendees will learn the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, educate the audience on the essential elements of a thorough response. Also attendees will learn the proper structure of the response to ensure the regulatory agency’s expectations […]

An FDA inspection can be a stressful and challenging experience. This webinar will help you understand the basics of FDA inspections so you can be well prepared. We will discuss how to prepare for an inspection, what to do during an inspection as well as common mistakes to be avoided. The FDA continues to write […]