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How to get a 510(k) for a Machine Learning Product
We will explain what a 510(k) is and explain the other FDA regulatory pathways. We will discuss how software can be considered a device by the FDA. The procedure to obtain a 510(k) will be explained. The contents of the submission to the FDA will be explain ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
- Mar 23, 2023
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
- Mar 23, 2023
Medical Device Software Validation Meeting FDA Regulations
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are us ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
- Mar 28, 2023
Current GXP expectations on Water system validation compliance
The most crucial factor to achieve Business Growth in Pharma manufacturing nowadays, is Compliance with GMP norms, so as to increase the technical and financial strength of Manufacturing units. Currently, the aspect focused on by most Auditors, both internal, ...
- Basic & Intermediate
- 90 Mins
- Hitendra Kumar
- Mar 31, 2023
Biomarkers in Drug Discovery and Development
Biomarkers are a key medical product development tool capable of facilitating the development of medical products and spurring innovation. When used in the right context, biomarkers have the potential to help expedite patient access to safe and effective treat ...
- Basic & Intermediate
- 60 Mins
- Stefano Persian
- Apr 05, 2023
Investigating OOS results
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor, and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the step ...
- Basic & Intermediate
- 60 Mins
- Danielle Delucy
- Apr 06, 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
- Apr 07, 2023
Human Error Solutions: How We Reduced 60% Of Human Errors In Less Than A Year, A Case Study
Pharmaceutical manufacturing sites continuously compete, even within the same company to maintain production volumes and avoid closures. To attain the status of high-performing organization manufacturing sites are implementing strategies and practices like ope ...
- Basic & Intermediate
- 90 Mins
- Ginette Collazo
- Apr 12, 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
- Apr 12, 2023
Proper Execution of Annual Product Reviews
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe. Annual Product Quality Review ...
- Intermediate
- 60 Mins
- Danielle Delucy
- Apr 20, 2023