Information Technology
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Best Practices for Having Successful Performance Discussions
How we talk about performance – how successful we are in doing this – is critical to the team relationships we forge and the effectiveness of team performance. Part of talking about performance is knowing how to have an... -
Best Practices in Preparation for an FDA Computer System Audit
The Webinar will discuss the importance of preparing for and participating in a computer system validation audit by regulatory agencies. Regulatory agencies fully expect companies to comply with the computer system validation guidelines that were established in 1983 and... -
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Best Practices in Providing Coaching and Feedback to Team Members
Why Should You Attend Most times, we conform and accomplish satisfactory work because we are forced to by management, our peers, and the organization. Superior work on the other hand is only achievable when we want to achieve... -
Big Data – Tools and Trends for Improving your Quality System
Data, data everywhere. In today’s world, we have access to tremendous amounts of data. Yet, it is difficult to translate this data into useful information. Translating data into meaningful information is a capability that can be a competitive strength... -
Blockchain Innovations that Connect and Protect the Supply Chain
This training program will discuss the new blockchain innovations particularly as they can be used to connect and protect the regulated supply chain. The focus will be on how this can enhance cMGP compliance while it strengthens a company’s... -
Building Interactive Spreadsheets
You’ll learn from Excel expert David Ringstrom, CPA, how to implement a variety of techniques to create spreadsheets that are interactive, accurate, and user friendly. In this presentation, David shows you how to use Excel’s form controls and features... -
Clinical Practices – Applying a Common Sense Approach to HIPAA Compliance
With HIPAA regulations that were created in the 1990’s, clinical practices need to learn how to apply a common-sense approach to HIPAA compliance. Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and... -
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Clinical Trials for The Intended Use of Software as a Medical Device
The FDA regulates standalone software as a medical device (SaMD) that is used for medical treatment or diagnostic applications. The clinical impact and corresponding risk associated with the use SaMS must incorporate a number of cross matching factors. Applying... -
Computer System Validation and Part 11 Compliance
This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based... -
Computer System Validation: Step-by-Step
The validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. This is proven through many FDA warning letters related to software and computer system validation, especially in the... -
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Computerized Systems and Data Integrity – Avoiding The Top Five Regulatory Pitfalls
Data Integrity and trustworthiness, the fundamental goals of computerized systems compliance and validation (CSV), have recently become a specific focus of severe and numerous enforcement actions by the US Food and Drug Administration (FDA) and other global regulatory agencies.... -
Conducting an Effective Software Validation of Medical Device to Meet FDA Requirements
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will... -
Coronavirus Pandemic – Crisis Response and Preparedness – Documentation, IT Systems and Data Integrity
Data security is the high priority in any organization but especially in regulated industries. Companies need to safeguard against every possible vulnerability across their entire infrastructure. Ongoing coronavirus pandemic is grabbing everyone’s attention, including many scammers. As with other... -
Coronavirus Pandemic – Crisis Response and Preparedness – Documentation, IT Systems and Data Integrity
Data security is the high priority in any organization but especially in regulated industries. Companies need to safeguard against every possible vulnerability across their entire infrastructure. Ongoing coronavirus pandemic is grabbing everyone’s attention, including many scammers. As with other... -
Coronavirus Pandemic – Crisis Response and Preparedness – Documentation, IT Systems and Data Integrity
Data security is the high priority in any organization but especially in regulated industries. Companies need to safeguard against every possible vulnerability across their entire infrastructure. Ongoing coronavirus pandemic is grabbing everyone’s attention, including many scammers. As with other... -
CSV Step-by-Step
Areas Covered in the Session : Formation of Validation Team Writing Effective URS Deliverable SRS and GxP Assessment (Template discuss GxP Assessment) Qualification (IQ, OQ, PQ) and Traceability Matrix Effective Installation and Testing Effective SOPs Validation & Revalidation Qualification...
