This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in ...
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 g ...
What are the basics of an enterprise maintenance-focused Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001, the international standard for Quality Management Systems for all business or industri ...
The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing d ...
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are us ...
The training session aims to provide participants with an understanding of the International Council for Harmonization (ICH) Q9 guideline, with a focus on the revised version, ICH Q9(R1). Participants will learn about the principles, concepts, and application ...
In the manufacture and quality control of medicinal products, compliance with the GMP rules is the decisive aspect for manufacturing high-quality products. For this reason, every staff member in the pharmaceutical industry has to be familiar with the basic GMP ...
“All software, firmware, ladder logic, must be validated” – US FDA. Verification and validation requirements have always been part of the US FDA’s GMPs. Where does 21 CFR Part 11 fit in? Pt 11 “selective enforcement”? “Add on”? Companies still struggle with th ...
Attend this webinar to learn the importance of doing a complete impact assessment prior to implementation of changes under change control. Tools and techniques will be presented to aid in organizing and streamlining impact assessments.
This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation w ...
