Webinar Search Results: 9	Topic: Not Specified	Category: All	Speaker: Carolyn Troiano

Trends in FDA Compliance and Enforcement for Regulated ...

Trends in FDA Compliance and Enforcement for Regulated Systems

FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules.

Carolyn Troiano

November 11, 2025
90 Minutes
US$149.00
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FDA Guidance for use of Social Media by Regulated Indus...

FDA Guidance for use of Social Media by Regulated Industries (Updated to include Recent Guidance from FDA)

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, tobacco and tobacco-related (e-liquid, cigars).

Carolyn Troiano

November 14, 2025
90 Minutes
US$149.00
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Computer System Validation (CSV) vs. Computer S...

Computer System Validation (CSV) vs. Computer System Assurance (CSA): Aligning Agile to the GAMP®5 "V" Model & System Development Life Cycle (SDLC)

The FDA has been moving in the direction of newer technology in an effort to no longer be a bottleneck to industry innovation.

Carolyn Troiano

November 17, 2025
90 Minutes
US$149.00
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GAMP®5, 2nd Edition and Alignment with FDA's Dr...

GAMP®5, 2nd Edition and Alignment with FDA's Draft Guidance for Computer Software Assurance (CSA)

We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.

Carolyn Troiano

November 20, 2025
90 Minutes
US$149.00
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Pharma 4.0: Next Generation Technology Approach to ...

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

So what is next for the modernization of the processes involved in compliance for FDA-regulated systems, keeping in mind the guidance documents provide thus far?

Carolyn Troiano

November 25, 2025
90 Minutes
US$149.00
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Data Integrity and Governance for Computer Systems Regu...

Data Integrity and Governance for Computer Systems Regulated by FDA

Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry.

Carolyn Troiano

December 1, 2025
90 Minutes
US$149.00
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Data Privacy: California Privacy Rights Act (CP...

Data Privacy: California Privacy Rights Act (CPRA), Health Information Portability & Accountability Act (HIPAA), and General Data Protection Regulation (GDPR)

Similarly, HIPAA and GDPRs extend protections to consumers residing in the US and the EU. These will be discussed along with the requirements for compliance.

Carolyn Troiano

December 4, 2025
90 Minutes
US$149.00
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Best Practices in Preparation for an FDA Computer Syste...

Best Practices in Preparation for an FDA Computer System Audit

In particular, industry citations have increased as they relate to areas of Part 11 and data integrity.

Carolyn Troiano

December 9, 2025
90 Minutes
US$149.00
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Using IT Audit Trails to Support FDA 21 CFR Part 11 and...

Using IT Audit Trails to Support FDA 21 CFR Part 11 and Data Integrity Compliance

FDA's recent focus on 21 CFR Part 11 and data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries.

Carolyn Troiano

December 12, 2025
90 Minutes
US$149.00
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