Information Technology
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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... -
CSV Workshop – Chennai – March 19 & 20, 2020
CSV , Data Integrity & 21 CFR part 11 workshop Location: Chennai Dates: March 19 & 20, 2020 -
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Customs – Trade Partnership Against Terrorism (C-TPAT) and Supply Chain Security
The Customs-Trade Partnership Against Terrorism (C-TPAT) is a voluntary supply chain security program led by U.S. Customs and Border Protection (CBP). It is intended to improve the security of supply chains of private enterprises against the threat of terrorism.... -
Cybersecurity – FDA Requirements Masterclass
Cybersecurity is the art of protecting networks, devices, and data from unauthorised access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information. Cybersecurity is the preventing the theft / modification of e-records by... -
Data Governance for Computer Systems Regulated by FDA
Organizations governed by FDA must adhere to strict requirements relative to data being captured, analyzed, reported or stored on computer systems. As such, organizations must be able to manage the data effectively, realize value from it, minimize the cost,...
