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 […]

AI / ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance’s for years, however, AI/ML programs fall outside the scope of these regulations and guidance’s. This happens because FDA approves the final, validated version of the software. The point […]

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. Procedures play a vital role in human reliability. Nevertheless, it is really […]

The letters ‘CE’ appear on many products that are traded on the single market in the European Economic Area (EEA). CE marking is required for many products. CE marks: Show that the manufacturer has checked that their products meet EU safety, health or environmental requirements Are an indicator of a product’s compliance with EU legislation […]

Compliance under GLP can be difficult. The setting up of a system to monitor the performance of methods and instruments can lessen this. Statistical Process Control (SPC) uses control charts and statistical guidelines to monitor a wide variety of things in the compliant laboratory. These generate a proactive system to assess problems early on and […]