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fda-inspections

Preparing for and Managing FDA Inspections: From SOPs to 483s

FDA

Speaker - José Mora

Learn how to prepare for and what to do during an FDA inspection and the close-out interview, and how to respond to an inspection.

$175.00

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Data Integrity Compliance for Computer Systems Regulated by FDA

Data Integrity Compliance for Computer Systems Regulated by FDA

FDA

Speaker - Carolyn Troiano

Learn about trends in FDA compliance & enforcement, as they relate to data integrity, and how to improve your practices to meet requirements

$295.00

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Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

FDA

Speaker - Carolyn Troiano

Learn the latest risk-based approach to Computer System Validation, 21 CFR Part 11 requirements based on current FDA compliance expectations

$175.00

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Ensuring Compliance with FDA Advertising and Promotional Requirements

Ensuring Compliance with FDA Advertising and Promotional Requirements

FDA

Speaker - Dr. Michael Redmond

Learn in detail about what FDA requires of pharma and device firms when it comes to advertising and promotions (including social media).

$175.00

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How to write SOPs to avoid human error

How to Write SOPs that Avoid Human Error

FDA

Speaker - Ginette Collazo

Learn the best practices for writing SOPs to reduce the likelihood of human error in FDA/ GMP-regulated manufacturing environments.

$175.00

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human-error

Human Error Reduction Techniques in GMP manufacturing

FDA

Speaker - Ginette Collazo

Get an understanding of human errors in GMP-related environments, factors and causes, and control measures to reduce the same.

$175.00

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