We will explore the latest best industry practices offered in GAMP®5 (Second Edition) and understand what it offers to those validation computer systems in the FDA-regulated industries.

Carolyn Troiano

• April 18, 2024
• 90 Minutes
• US$149.00
• Enroll

This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.

Carolyn Troiano

• April 22, 2024
• 90 Minutes
• US$149.00
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Advancements in technology have forced organizations to rethink business models.

Carolyn Troiano

• April 23, 2024
• 90 Minutes
• US$149.00
• Enroll

Advancements in technology have forced organizations to rethink business models.

Carolyn Troiano

• April 26, 2024
• 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. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.

Carolyn Troiano

• May 2, 2024
• 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. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.

Carolyn Troiano

• May 7, 2024
• 90 Minutes
• US$149.00
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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

• May 14, 2024
• 90 Minutes
• US$149.00
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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

• May 22, 2024
• 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

• May 27, 2024
• 3 Hours
• US$299.00
• Enroll

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

• June 3, 2024
• 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

• June 10, 2024
• 90 Minutes
• US$149.00
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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

• June 17, 2024
• 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. 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. The best way to preserve database records, those that are uniformly structured, is to place an audit trail on the file. The audit trail will create a new record every time a record is updated, including the old value, new value, date, time, person who authentically performed the modification to the record, and the reason for the change.

Carolyn Troiano

• June 24, 2024
• 90 Minutes
• US$149.00
• Enroll