Information Technology
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FDA Regulations and Requirements for Artificial Intelligence / Machine Learning
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 guidance.... -
FDA’s Latest Import Automated Commercial Environment (ACE) Program for 2017
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA’s import software screening program (PREDICT) and the U.S. Custom’s ACE software program require more information from the foreign source(s). Information on the entry’s commercial... -
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FDA’s Recent Regulation on the Use of Social Media
This seminar will help you understand in detail the application of FDA’s latest guidance on the use of social media in presenting and promoting information about drug products and medical devices subject to FDA regulation. This is critical in... -
GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations
Various firms are subject to various relevant and applicable federal regulations including, but not limited to, Good Laboratory Practice (GLP), Current Good Manufacturing Practice (cGMP), and Good Clinical Practice (GCP). It is important for the industry to accurately understand... -
Good Clinical Practices Review of ICH E6
The webinar will establish the foundation for this subject by defining GCP and discussing GCP in relation to its historical perspective. The thirteen core principles of GCP are essential to understanding how GCP is structured and expected to be... -
Good Documentation Practices to Support Computer System Validation
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The... -
Good Documentation Practices to Support Computer System Validation
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The... -
HIPAA 2018 – Understanding Compliance Program Requirements
Being in compliance with HIPAA in 2018 involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place.... -
HIPAA and Health IT – What You Need to Know as a Business Associate
This training program will highlight the HIPAA Security and Privacy Rules and analyze the consequences of being a business associate. It will also examine what a HIPAA compliance program and a HIPAA risk management plan entail. As defined by... -
HIPAA and Health IT – What You Need to Know as a Business Associate
This training program will highlight the HIPAA Security and Privacy Rules and analyze the consequences of being a business associate. It will also examine what a HIPAA compliance program and a HIPAA risk management plan entail. As defined by... -
HIPAA and Health IT – What You Need to Know as a Business Associate
This training program will highlight the HIPAA Security and Privacy Rules and analyze the consequences of being a business associate. It will also examine what a HIPAA compliance program and a HIPAA risk management plan entail. As defined by... -
HIPAA Breaches – How to Reduce Human Error
More than 175,000,000 individuals have been affected by HIPAA data breaches. During the last year, 78% of HIPAA breaches are caused by human error. That means almost all of those breaches may have been prevented. Does your organization have... -
HIPAA Breaches – How to Reduce Human Error
More than 175,000,000 individuals have been affected by HIPAA data breaches. During the last year, 78% of HIPAA breaches are caused by human error. That means almost all of those breaches may have been prevented. Does your organization have... -
HIPAA Compliance Monitoring and Auditing
We’ll use real-world examples to help explain the Privacy Rule, which governs patient rights and disclosure of protected health information (PHI), We’ll explain what’s meant by covered entities (CE), business associates (BA), and many other relationships within the health... -
HIPAA Risk Assessment – Understanding the Process
Understanding the proper methodologies on conducting a HIPAA Risk Assessment based on the requirements of the HIPAA Security Rule is critical for any organization. The U.S. Department of Health and Human Services requires all organizations handling protected health information... -
How to Deploy Root Cause and CAPA to Minimize Human Error
Many variables, from procedures, to training to workplace environment, affect human behavior. You need to understand human behavior and the psychology of error in order to implement a process dedicated to investigating and fixing human errors. Human Error Solutions’...
