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Results for tag: "FDA Form 483"

The Most Serious FDA 483s - How to Avoid Them - Product Thumbnail Image

The Most Serious FDA 483s - How to Avoid Them

  • Training
  • 90 Minutes
  • Global
Learning Design Controls through review of FDA 483 Observations - Product Thumbnail Image

Learning Design Controls through review of FDA 483 Observations

  • Training
  • 75 Minutes
  • Global
How to perform effective supplier audits, and avoid FDA 483 - Product Thumbnail Image

How to perform effective supplier audits, and avoid FDA 483

  • Training
  • 60 Minutes
  • Global
FDA Computer System Validation Training: Pack of 6 Training Courses - Product Thumbnail Image

FDA Computer System Validation Training: Pack of 6 Training Courses

  • Training
  • 8 Hours
  • Global
FDA Data Integrity Training: Pack of 6 Training Courses - Product Thumbnail Image

FDA Data Integrity Training: Pack of 6 Training Courses

  • Training
  • 9 Hours
  • Global
Major CGMP Issues - US FDA Concerns in 2022 - Product Thumbnail Image

Major CGMP Issues - US FDA Concerns in 2022

  • Training
  • 90 Minutes
  • United States
Computer System Validation and Part 11 Compliance - Product Thumbnail Image

Computer System Validation and Part 11 Compliance

  • Training
  • 60 Minutes
  • Global
Equipment Qualification Basics - Product Thumbnail Image

Equipment Qualification Basics

  • Training
  • 90 Minutes
  • Global
FDA: Mock and Pre-Approval Inspections (PAIs) - Part II - Product Thumbnail Image

FDA: Mock and Pre-Approval Inspections (PAIs) - Part II

  • Training
  • 120 Minutes
  • Global
How To Respond To A FDA Inspection And Warning Letter - Product Thumbnail Image

How To Respond To A FDA Inspection And Warning Letter

  • Training
  • 120 Minutes
  • Global
21 CFR Part 111 - Current FDA 483 Observations and Warning Letters Review - Product Thumbnail Image

21 CFR Part 111 - Current FDA 483 Observations and Warning Letters Review

  • Training
  • 60 Minutes
  • Global
What are best practices for creating a Risk Management File? - Product Thumbnail Image

What are best practices for creating a Risk Management File?

  • Training
  • 60 Minutes
  • Global
Responding to FDA 483s and FDA Warning Letters - Best Practices - Product Thumbnail Image

Responding to FDA 483s and FDA Warning Letters - Best Practices

  • Training
  • 120 Minutes
  • Global
How to successfully audit software systems, and thereby avoid having FDA write software-related 483's and warning letters - Product Thumbnail Image

How to successfully audit software systems, and thereby avoid having FDA write software-related 483's and warning letters

  • Training
  • 60 Minutes
  • Global
What will FDA expect and request from your firm during Design Control portions of Inspections? - Product Thumbnail Image

What will FDA expect and request from your firm during Design Control portions of Inspections?

  • Training
  • 60 Minutes
  • Global
FDA Inspections: What Regulations Expect - Product Thumbnail Image

FDA Inspections: What Regulations Expect

  • Training
  • 90 Minutes
  • Global
Preparing for a U.S. FDA Audit - Product Thumbnail Image

Preparing for a U.S. FDA Audit

  • Training
  • 60 Minutes
  • United States
'Performing effective supplier audits: a coming FDA compliance focus' - Product Thumbnail Image

'Performing effective supplier audits: a coming FDA compliance focus'

  • Training
  • Global
Key differences in Design Control Requirements between ISO13485:2003 and the FDA Quality System Regulation - Product Thumbnail Image

Key differences in Design Control Requirements between ISO13485:2003 and the FDA Quality System Regulation

  • Training
  • 60 Minutes
  • Global
FDA Compliance and Quality inspections - Product Thumbnail Image

FDA Compliance and Quality inspections

  • Training
  • 60 Minutes
  • Global
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The FDA Form 483 market is a subset of the pharmaceutical manufacturing industry. It is a regulatory document issued by the U.S. Food and Drug Administration (FDA) to a pharmaceutical manufacturing facility after an inspection. The form is used to document any observed violations of the FDA's Current Good Manufacturing Practice (CGMP) regulations. It is a critical tool for the FDA to ensure that pharmaceutical products are safe and effective. The FDA Form 483 market is composed of pharmaceutical manufacturers, contract manufacturers, and other related companies. Companies in this market include Pfizer, Merck, Novartis, GlaxoSmithKline, Sanofi, Johnson & Johnson, AstraZeneca, Bristol-Myers Squibb, and Eli Lilly. Show Less Read more