Live Webinars

The webinar will establish the foundation for this subject by defining GCP and discussing GCP in relation to its historical perspective. The thirteen core principles of GCP are essential to understanding how GCP is structured and expected to be manifest in clinical trial execution. ICH E6 will be reviewed in detail as that guideline serves […]

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System.Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly,well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in well documented and […]

Statistical process control (SPC) is a method of quality control which employs statistical methods to monitor and control a process. It is one of the fifteen subpart requirements of the US FDA’s QS Regulation, 21 CFR 82, the Medical Device cGMP’s. It can be a key tool in meeting the Production and Process Control (P&PC) […]

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 for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of […]

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software […]

Data integrity has always been a key component of all the cGMP’s, only now taking on greater emphasis due to the use of electronic records / signatures. Cybersecurity is the preventing the theft / modification of e-records by unauthorized access. A growing concern for all – legal, financial, consumer, personal, and the FDA. t’s a […]

This webinar will discuss the FDA requirements for design, validation and monitoring of pharmaceutical water systems. There are many different types of pharmaceutical waters and each must be fit for its intended use. Pharma water must be controlled for impurities. Pharma water systems must be designed, validated and monitored to ensure that the water produced […]

Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology. In this session, expert speaker Danielle DeLucy will describe the steam sterilization mechanism as it relates to endospores and bacterial cells. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process. Sterilization process […]

This seminar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could result in injury or death to a patient or consumer. A serious threat, it must be […]

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 […]

This latest webinar will showcase possibilities with some case study examples of what can be done. The case study for manufacturing, maintenance, instrumentation, Quality assurance and regulatory assurance functions will be discussed. It is a must attend webinar to realize the potential of the technology that you can use at your organization. Areas Covered in […]

This interactive webinar by industry expert – David Nettleton will explain how to avoid FDA 483s by proper configuration and validation of GxP compliant spreadsheet applications. This webinar will help you follow the step-by-step instructions in real time as we configure Excel for audit trails, security features, and data entry verification. You will get a […]