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37 results of "Hospital & Healthcare x" and "Law & Audits x"
Live Webinar

Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data, & FDA Compliance

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 ...

Live Webinar

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.  This webinar will help you understand the FDA’s current thinking on vendor audit ...

Live Webinar

Employer and Payroll Updates due to OBBBA 2025

On July 4th 2025 President Trump signed in the One Big Beautiful Bill Act into law. This legislation is sweeping legislation that impacts all aspects of the United States. However, there are major impacts coming to employers and payroll departments across the ...

Live Webinar

Developing and Implementing Quality Culture in the Organization and Why it’s Important

In today's regulatory landscape, a strong quality culture is essential for preventing compliance issues and ensuring consistent product quality. Regulatory bodies, including the FDA, increasingly emphasize the need for organizations to establish and maintain a ...

Recorded Webinar

Artificial Intelligence (AI), Machine Learning, and the FDA

The artificial intelligence technologies granted FDA marketing authorization and cleared by the agency so far are generally called “locked” algorithms that don’t continually adapt or learn every time the algorithm is used. However, the FDA is looking beyond th ...

Recorded Webinar

21 CFR Part 11 Electronic Records and Signatures Compliance for Computer Systems Regulated by FDA

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, ...

Recorded Webinar

Data Integrity - US FDA Requirements

Due to the growth of electronic records and electronic signatures in CGMP documentation, as well as computer-controlled manufacturing, and medical devices, the US FDA has issued a draft Guidance for Industry, outlining its expectations for increased data integ ...

Recorded Webinar

21 CFR Part 11 Electronic Records and Signatures Compliance for Computer Systems Regulated by FDA

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, ...

Recorded Webinar

Medical Device Cybersecurity and FDA Compliance

This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could res ...

Recorded 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 FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security practices, requ ...

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Validity : 24th Aug'25 to 03rd Sep'25