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142 results of "Life Sciences x" and "Clinical Research x"
Live Webinar

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 ...

Live Webinar

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.

Live Webinar

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 ...

Live Webinar

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, ...

Live Webinar

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 ...

Live Webinar

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 ...

Live Webinar

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, ...

Live Webinar

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 ...

Live Webinar

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 ...

Live Webinar

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 ...