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Recorded Webinar

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in ...

Recorded Webinar

ChatGPT / AI and Project Management for FDA-Regulated Companies

This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning concepts including some common chatbot / AI tools (and their risks), Lean / Agile principles, for new product development, Desig ...

Recorded Webinar

DHF (Design History File),DMR, DHR, Technical Documentation Files – US FDA and EU MDR Requirements

This webinar will examine the existing requiements for the US  FDA's DHF -- including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF. It will consider the EU's recently revised MDR and it's Technical Documentation File requirem ...

Recorded Webinar

Form W-9 Compliance to Avoid Penalties: TIN Verification, B Notices and Backup Withholding

Obtaining Form W-9 from is the first step in assuring compliance in information return reporting requirements. The Form provides information required to determine if the business needs to file an information return as well as the correct name and tax ID number ...

Recorded Webinar

Cybersecurity - The US FDA's Requirements

Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information. Due to the growth of the cybersecurity threat to electroni ...

Recorded Webinar

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 software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and g ...

Recorded Webinar

ChatGPT for Excel

This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel ...

Recorded Webinar

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 ...

Recorded Webinar

ChatGPT for Excel

This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel ...

Recorded Webinar

The Validation Master Plan – The Unwritten Requirements

Verification and validation requirements have always been part of the US FDA’s cGMPs. However, with increasing technology, both industry, and regulatory agencies' expectations have increased. Recent high-profile field problems indicate that V&V activities are ...

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Validity : 08th Sep'26 to 18th Sep'26