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

• July 9, 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. 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

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

We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities by applying a sound, project management approach. Each validation effort includes a vast set of activities and tasks required to get the job done. These can be managed more effectively by better understanding how to apply a project management approach to them all, regardless of size.

Carolyn Troiano

• July 17, 2025
• 90 Minutes
• US$149.00
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FDA's recent focus on 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

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

In particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended.

Carolyn Troiano

• July 23, 2025
• 90 Minutes
• US$149.00
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Advancements in technology have forced organizations to rethink business models.

Carolyn Troiano

• July 29, 2025
• 90 Minutes
• US$149.00
• Enroll

We will explore the best practices and strategic approach for evaluating Excel spreadsheets used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.

Carolyn Troiano

• August 1, 2025
• 90 Minutes
• US$149.00
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Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.

Carolyn Troiano

• August 11, 2025
• 90 Minutes
• US$149.00
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We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance with FDA's guidance.

Carolyn Troiano

• August 18, 2025
• 90 Minutes
• US$149.00
• Enroll

We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.

Carolyn Troiano

• August 20, 2025
• 90 Minutes
• US$149.00
• Enroll

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Carolyn Troiano

• August 21, 2025
• 3 Hours
• US$299.00
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During the webinar, we will discuss FDA's considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee.

Carolyn Troiano

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

Advancements in technology have forced organizations to rethink business models.

Carolyn Troiano

• August 26, 2025
• 90 Minutes
• US$149.00
• Enroll

Advancements in technology have forced organizations to rethink business models.

Carolyn Troiano

• August 28, 2025
• 90 Minutes
• US$149.00
• Enroll

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