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

• June 24, 2025
• 90 Minutes
• US$149.00
• Enroll

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

• June 25, 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

• July 1, 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

• 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
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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

• 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