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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
  • January 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
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
FDA Inspection (Recorded) - Product Thumbnail Image

FDA Inspection (Recorded)

  • Training
  • February 2024
  • 2 Days
  • 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
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
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
  • August 2023
  • 2 Days
  • Global
From
Lifecycle Management of Analytical Methods and Procedures : Current Trends & Your Questions Answered (Recorded) - Product Thumbnail Image

Lifecycle Management of Analytical Methods and Procedures : Current Trends & Your Questions Answered (Recorded)

  • Training
  • August 2023
  • 2 Days
  • Global
From
FDA Enforcement Manual - Online - Product Thumbnail Image

FDA Enforcement Manual - Online

  • Directory
  • April 2024
  • Global
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 2024
  • 2 Days
  • Global
3-Hour Virtual Seminar on Handling OOS Test Results and Completing Robust Investigations - Webinar (Recorded) - Product Thumbnail Image

3-Hour Virtual Seminar on Handling OOS Test Results and Completing Robust Investigations - Webinar (Recorded)

  • Webinar
  • November 2023
  • 3 Hours
  • Global
From
Raw Material Compliance in a cGMP Environment - Training on Issues & Solutions (Recorded) - Product Thumbnail Image

Raw Material Compliance in a cGMP Environment - Training on Issues & Solutions (Recorded)

  • Training
  • October 2023
  • 2 Days
  • Global
From
CSV Boot Camp - 3-Day Certification Course (Recorded) - Product Thumbnail Image

CSV Boot Camp - 3-Day Certification Course (Recorded)

  • Training
  • September 2023
  • 3 Days
  • Global
From
4-Hour Virtual Seminar on Batch Record Review and Product Release - Webinar (Recorded) - Product Thumbnail Image

4-Hour Virtual Seminar on Batch Record Review and Product Release - Webinar (Recorded)

  • Webinar
  • September 2023
  • 4 Hours
  • Global
From
Enhancing Quality Oversight in Pharmaceutical Contract Manufacturing Organizations (Recorded) - Product Thumbnail Image

Enhancing Quality Oversight in Pharmaceutical Contract Manufacturing Organizations (Recorded)

  • Training
  • August 2023
  • 2 Days
  • Global
From
Audit Like the FDA - Effective Internal Audit Program (Recorded) - Product Thumbnail Image

Audit Like the FDA - Effective Internal Audit Program (Recorded)

  • Training
  • July 2023
  • 2 Days
  • Global
From
FDA Regulatory Compliance for Drug and Biotech Product - Past, Present and Future (Recorded) - Product Thumbnail Image

FDA Regulatory Compliance for Drug and Biotech Product - Past, Present and Future (Recorded)

  • Training
  • May 2023
  • 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
  • November 2023
  • 120 Minutes
  • Global
From
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements - Webinar (Recorded) - Product Thumbnail Image

3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements - Webinar (Recorded)

  • Webinar
  • May 2023
  • 180 Minutes
  • Global
From
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
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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