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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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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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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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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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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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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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
• Enroll

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
• Enroll