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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 ...
In this webinar, you will learn to use little-known Outlook features and advanced features that are hiding in plain sight. Not only will you learn about the features, but you’ll learn the benefits of those features from a time management viewpoint. Effective ...
Organizations often use internal or external change management experts to help the organization create effective change management programs and plans. However, these change management experts often engage with key stakeholders without a plan to provide change ...
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 ...
In order to solve problems, every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can a ...
So, maybe you find yourself suddenly in charge of your department's or team's SharePoint site. What do you do? Where do you start?
More and more, your company is asking you to do some things with Excel spreadsheets that may leave you challenged or even overwhelmed. Maybe someone else worked on a spreadsheet, and then they moved on, and now you are in charge of that spreadsheet. That is ...
In Excel, sometimes there is a need to look up information from a table or from a different sheet, or to link the sheets together.
Process of following the procedures and processes that are agreed on during a selection audit process. It identifies nonconformances in the manufacturing process, engineering change process, invoicing process, quality process, and also the supplier/shipment pr ...
“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 ...