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The Webinar will focus on the importance of ensuring that the electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes developing a company philosophy and approach ...
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer sys ...
This interactive webinar explains how to configure and validate GxP compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. Understand ho ...
Excel functions can greatly enhance your ability to perform tasks in day-to-day activities in Excel. While there are hundreds of functions available, there are 10 functions that all Excel users should know. Whether you are an office worker, a small business ...
This training on FDA software validation and verification will provide you with the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
Uses and abuses Resilience of materials Resilience applied to financial institutions The stages in handling shocks Stress-testing: an ex-ante view Resilience and bank supervision Resistance vs. resilience Crisis management Towards the optimal way to ...
PivotTables can help you sort and sift through large data sets to focus quickly on just the data elements that matter most to your specific needs. In just one fast-paced and informative training session, you’ll learn how to use PivotTables to sort your data m ...
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 Regulat ...
This project management training for FDA-regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for the successful development and implementation of pro ...
This training program will help attendees understand the Emergency Planning and Community Right-to-Know Act (EPCRA) Toxic Release Inventory (TRI) Form R reporting requirements. It will also elucidate what the EPCRA TRI Form R is, when they are required to be f ...