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Results for tag: "FDA Warning Letter"

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Training Course (Recorded) - Product Thumbnail Image

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Training Course (Recorded)

  • Training
  • February 2025
  • 2 Days
  • Global
From
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Training Course (Recorded) - Product Thumbnail Image

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Training Course (Recorded)

  • Training
  • November 2024
  • 2 Days
  • Global
From
FDA Inspection (Recorded) - Product Thumbnail Image

FDA Inspection (Recorded)

  • Training
  • June 2024
  • 2 Days
  • Global
From
FDA Regulatory Compliance for Drug and Biotech Product Training Course (Recorded) - Product Thumbnail Image

FDA Regulatory Compliance for Drug and Biotech Product Training Course (Recorded)

  • Training
  • March 2025
  • 2 Days
  • Global
From
FDA Inspection Preparedness and Compliance (Recorded) - Product Thumbnail Image

FDA Inspection Preparedness and Compliance (Recorded)

  • Training
  • September 2024
  • 2 Days
  • Global
From
Risk Management of Raw Materials in a GMP Environment Course (Recorded) - Product Thumbnail Image

Risk Management of Raw Materials in a GMP Environment Course (Recorded)

  • Training
  • June 2024
  • 2 Days
  • Global
From
Writing and Enforcing SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations Course (Recorded) - Product Thumbnail Image

Writing and Enforcing SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations Course (Recorded)

  • Training
  • March 2024
  • 3 Days
  • Global
FDA Enforcement Manual - Online - Product Thumbnail Image

FDA Enforcement Manual - Online

  • Directory
  • March 2025
  • Global
FDA Inspections: From Site Preparation to Response (Recorded) - Product Thumbnail Image

FDA Inspections: From Site Preparation to Response (Recorded)

  • Training
  • February 2025
  • 2 Days
  • Global
From
FDA Inspection Preparedness and Compliance (Recorded) - Product Thumbnail Image

FDA Inspection Preparedness and Compliance (Recorded)

  • Training
  • December 2024
  • 2 Days
  • Global
From
Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations - Webinar (Recorded) - Product Thumbnail Image

Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations - Webinar (Recorded)

  • Webinar
  • September 2024
  • 120 Minutes
  • Global
From
Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations - Webinar (Recorded) - Product Thumbnail Image

Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations - Webinar (Recorded)

  • Webinar
  • December 2024
  • 120 Minutes
  • Global
From
FDA Trends for Computer System Validation (CSV) Compliance and Enforcement (May 21, 2025) - Product Thumbnail Image

FDA Trends for Computer System Validation (CSV) Compliance and Enforcement (May 21, 2025)

  • Training
  • May 2025
  • 1 Day
  • Global
From
Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile Production FDA & ICH Expectations and Guidance (Recorded) - Product Thumbnail Image

Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile Production FDA & ICH Expectations and Guidance (Recorded)

  • Training
  • July 2024
  • 90 Minutes
  • Global
GxP/GMP Regulation Testing, Services Market in Food, Pharmaceuticals, Medical Devices, and Cosmetics - Product Thumbnail Image

GxP/GMP Regulation Testing, Services Market in Food, Pharmaceuticals, Medical Devices, and Cosmetics

  • Report
  • June 2019
  • 248 Pages
  • Global
From
Process Validation Training Course (FDA and EU Annex 15: Qualifications and Validation) (Recorded) - Product Thumbnail Image

Process Validation Training Course (FDA and EU Annex 15: Qualifications and Validation) (Recorded)

  • Training
  • January 2024
  • 2 Days
  • Global
From
Master Validation Plan - The Unwritten Requirements (Recorded) - Product Thumbnail Image

Master Validation Plan - The Unwritten Requirements (Recorded)

  • Training
  • July 2024
  • 3 Hours
  • Global
From
The FDA QMSR and the Key Elements of QSIT cGMP Inspection and Audits for Medical Device Manufacturers (Recorded) - Product Thumbnail Image

The FDA QMSR and the Key Elements of QSIT cGMP Inspection and Audits for Medical Device Manufacturers (Recorded)

  • Training
  • February 2024
  • 2 Days
  • Global
From
Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations Webinar - Webinar (Recorded) - Product Thumbnail Image

Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations Webinar - Webinar (Recorded)

  • Webinar
  • February 2024
  • 120 Minutes
  • Global
From
OOS and OOT Investigations Course - Best Practices, Key Components and a Comprehensive Review of the FDA Requirements (Recorded) - Product Thumbnail Image

OOS and OOT Investigations Course - Best Practices, Key Components and a Comprehensive Review of the FDA Requirements (Recorded)

  • Training
  • September 2023
  • 2 Days
  • Global
From
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The FDA Warning Letter market within the context of Pharmaceutical Manufacturing is a market that focuses on the enforcement of regulations and standards set by the U.S. Food and Drug Administration (FDA). Companies in this market are responsible for ensuring that their products meet the FDA's requirements for safety, efficacy, and quality. Companies must also comply with the FDA's Good Manufacturing Practices (GMPs) and other regulations. Companies that fail to meet these standards may receive a warning letter from the FDA, which can result in fines, product recalls, or other penalties. Companies in this market must also be aware of the latest developments in the industry, such as new regulations or changes to existing regulations. Some companies in the FDA Warning Letter market include Pfizer, Merck, Johnson & Johnson, Novartis, and GlaxoSmithKline. Show Less Read more