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

• September 3, 2025
• 90 Minutes
• US$149.00
• Enroll

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
• Enroll

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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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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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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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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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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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
• Enroll

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, ML and ChatGPT and others are becoming prevalent.

Carolyn Troiano

• October 6, 2025
• 90 Minutes
• US$149.00
• Enroll

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, ML and ChatGPT and others are becoming prevalent.

Carolyn Troiano

• October 10, 2025
• 90 Minutes
• US$149.00
• Enroll

Providing safe and effective medical devices is in the best interests of all those involved in the development, manufacturing, testing, and distribution of these products. You will learn about the Q-Submission program providing industry with pathways for engaging FDA early for feedback to aid in product development.

Carolyn Troiano

• October 20, 2025
• 90 Minutes
• US$149.00
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The guidance on validation has been modified with the FDA's proposed draft guidance for Computer Software Assurance (CSA) in September 2022.

Carolyn Troiano

• October 22, 2025
• 90 Minutes
• US$149.00
• Enroll

By applying storytelling to FDA-regulated system validation, attendees will:

Carolyn Troiano

• October 31, 2025
• 90 Minutes
• US$149.00
• Enroll

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

Carolyn Troiano

• November 3, 2025
• 90 Minutes
• US$149.00
• Enroll

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
• Enroll