Webinar Search Results: 22	Topic: Not Specified	Category: All	Speaker: Carolyn Troiano

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Trial Master File (TMF)/eTMF, & FDA'...

Trial Master File (TMF)/eTMF, & FDA's Draft Guidance for Electronic Records/Signatures Used in Clinical Trials

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.

Carolyn Troiano

September 4, 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

September 9, 2025
90 Minutes
US$149.00
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Artificial Intelligence (AI), Machine Learning,...

Artificial Intelligence (AI), Machine Learning, and FDA Compliance for Computer Systems and Data

As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI is becoming prevalent.

Carolyn Troiano

September 12, 2025
90 Minutes
US$149.00
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Data Integrity and Privacy: 21 CFR Part 11, Annex 1...

Data Integrity and Privacy: 21 CFR Part 11, Annex 11, & General Data Protection Regulation (GDPR)

During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizen's personal data when they reside in the European Union (EU).

Carolyn Troiano

September 19, 2025
90 Minutes
US$149.00
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Best Practices for Auditing a Vendor of Computer System...

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

We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity.

Carolyn Troiano

September 22, 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

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

September 25, 2025
90 Minutes
US$149.00
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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. This webinar will help you understand the FDA's current thinking on computer systems that are validated and subject to inspection and audit.

Carolyn Troiano

September 26, 2025
90 Minutes
US$149.00
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