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Results for tag: "FDA Warning Letter"

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
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
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
Surviving an FDA Sponsor Inspection - Training for Success - Product Thumbnail Image

Surviving an FDA Sponsor Inspection - Training for Success

  • Training
  • 105 Minutes
  • Global
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) - Product Thumbnail Image

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

  • Training
  • Global
From
Kratom Industry Offers Own Standards As Another Firm Warned About FDA Rules - Product Thumbnail Image

Kratom Industry Offers Own Standards As Another Firm Warned About FDA Rules

  • Newsletter
  • April 2025
  • 3 Pages
  • Global
From
Vanda Warning Letter From US FDA Leaves Firm “Puzzled” - Product Thumbnail Image

Vanda Warning Letter From US FDA Leaves Firm “Puzzled”

  • Newsletter
  • April 2025
  • 3 Pages
  • United States
From
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
4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement - Webinar (Recorded) - Product Thumbnail Image

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement - Webinar (Recorded)

  • Webinar
  • October 2023
  • 240 Minutes
  • 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
Risk Management of Raw Materials in a GMP Environment Webinar - Webinar (Recorded) - Product Thumbnail Image

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

  • Webinar
  • September 2023
  • 90 Minutes
  • 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
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
The Quality System Regulation (cGMP, 21 CFR 210 & 211 and 820) - Webinar (Recorded) - Product Thumbnail Image

The Quality System Regulation (cGMP, 21 CFR 210 & 211 and 820) - Webinar (Recorded)

  • Webinar
  • July 2023
  • 90 Minutes
  • 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
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions (Philadelphia, PA, United States - Recorded) - Product Thumbnail Image

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions (Philadelphia, PA, United States - Recorded)

  • Training
  • March 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