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FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulation ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
- Nov 29, 2022
The Transfer of Validated Methods
This webinar will discuss the best practices for the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Dec 05, 2022
Outsourcing Software Development for Medical Devices
This webinar will discuss the skillsets to look for when outsourcing, how to know if the work is compliant (without having to be an expert in software development), how to manage outsourced development, and your responsibilities throughout the product lifecycl ...
- Basic & Intermediate
- 60 Mins
- Donald (Don) Hu
- Dec 07, 2022
The 6 Most Common Problems in FDA Software Validation and Verification
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.
- Basic & Intermediate
- 120 Mins
- David Nettleton
- Dec 15, 2022
HPLC Analytical Method Development and Validation
Instrumental liquid chromatography is an analysis widely used to determine purity, impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Dec 19, 2022
How to Deal with Bad Results Under GLP
Assessment of the cause for non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts a ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Jan 04, 2023
Computer System Validation (CSV) for FDA-Regulated Computers
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines. This includes the development of a company philosophy and approach and incorporating it into an overall computer syst ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- Jan 06, 2023
Analytical Method Validation Under Good Laboratory Practices - GLPs
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof t ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Jan 18, 2023
Excel Spreadsheets; develop and validate for 21 CFR Part 11 compliance
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 ...
- Basic & Intermediate
- 75 Mins
- David Nettleton
- Jan 20, 2023
Vendor Audit for Systems and Services for FDA-Regulated Systems
This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by the FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security practices, ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- Jan 23, 2023