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Results for tag: "Regulatory Affairs"

South East Asia Regulatory Compliance for Life Science Products - Hong Kong, Taiwan, Thailand, Singapore, Malaysia and Vietnam - Product Thumbnail Image

South East Asia Regulatory Compliance for Life Science Products - Hong Kong, Taiwan, Thailand, Singapore, Malaysia and Vietnam

  • Training
  • 90 Minutes
  • Hong Kong, Malaysia, ... Hong Kong, Malaysia, Singapore, Taiwan, Thailand, Vietnam, Asia Pacific
Health Canada's Enforcement of the Regulatory Requirements for the Manufacture, Advertising and Sale of Pharmaceuticals, Medical Devices and Natural Health Products - Product Thumbnail Image

Health Canada's Enforcement of the Regulatory Requirements for the Manufacture, Advertising and Sale of Pharmaceuticals, Medical Devices and Natural Health Products

  • Training
  • 60 Minutes
  • Canada
Implementing FDA's 21 CFR 111 for Dietary Supplements - Product Thumbnail Image

Implementing FDA's 21 CFR 111 for Dietary Supplements

  • Training
  • 75 Minutes
  • Global
Understanding the Current FDA Requirements for Raw Materials and Components - Product Thumbnail Image

Understanding the Current FDA Requirements for Raw Materials and Components

  • Training
  • 90 Minutes
  • Global
Updated EU filing and registration procedures (including the new variation rules coming in to force) - Product Thumbnail Image

Updated EU filing and registration procedures (including the new variation rules coming in to force)

  • Training
  • 60 Minutes
  • Europe
Changes in US FDA Enforcement - Product Thumbnail Image

Changes in US FDA Enforcement

  • Training
  • 90 Minutes
  • United States
Current Trends in FDA Inspections - Product Thumbnail Image

Current Trends in FDA Inspections

  • Training
  • 90 Minutes
  • Global
Site Preparation Strategy and Successful FDA Inspection - Product Thumbnail Image

Site Preparation Strategy and Successful FDA Inspection

  • Training
  • 60 Minutes
  • Global
How to respond to GXP (GCP, GLP, GMP, GPV) Inspection and Audit Findings using Correction and Preventative Action (CAPA) - Product Thumbnail Image

How to respond to GXP (GCP, GLP, GMP, GPV) Inspection and Audit Findings using Correction and Preventative Action (CAPA)

  • Training
  • 60 Minutes
  • Global
Marketing Beverages, Fruit Juice and Sports Drinks in Compliance with FDA Regulations - Product Thumbnail Image

Marketing Beverages, Fruit Juice and Sports Drinks in Compliance with FDA Regulations

  • Training
  • 60 Minutes
  • Global
Drug Master Files: New Requirements under GDUFA - Product Thumbnail Image

Drug Master Files: New Requirements under GDUFA

  • Training
  • 60 Minutes
  • Global
How to Withstand an FDA Audit of your Facility - Product Thumbnail Image

How to Withstand an FDA Audit of your Facility

  • Training
  • 60 Minutes
  • Global
Coping with a Difficult Compliance Officer when Responding to a 483, Warning Letter, Import Alert or Recall - Product Thumbnail Image

Coping with a Difficult Compliance Officer when Responding to a 483, Warning Letter, Import Alert or Recall

  • Training
  • 60 Minutes
  • Global
FDA Enforcement and Your Compliance Program - Product Thumbnail Image

FDA Enforcement and Your Compliance Program

  • Training
  • 60 Minutes
  • Global
FDA and Social Media - How to Promote your Products Using Web 2.0 in Compliance with FDA and FTC Laws and Regulations - Product Thumbnail Image

FDA and Social Media - How to Promote your Products Using Web 2.0 in Compliance with FDA and FTC Laws and Regulations

  • Training
  • 90 Minutes
  • Global
FDA's Revised 510(k) Process: The Medical Device Professional's Guide to Successfully Preparing 510(k) Submissions and Regulatory Compliance - Product Thumbnail Image

FDA's Revised 510(k) Process: The Medical Device Professional's Guide to Successfully Preparing 510(k) Submissions and Regulatory Compliance

  • Training
  • 70 Minutes
  • Global
Dietary Supplements and Nutraceuticals: Compliance with FDA's Current Manufacturing Requirements - Product Thumbnail Image

Dietary Supplements and Nutraceuticals: Compliance with FDA's Current Manufacturing Requirements

  • Training
  • 90 Minutes
  • Global
Auditing Systems for 21 CFR Part 11 Compliance: Preparing Yourself for Inspection - Product Thumbnail Image

Auditing Systems for 21 CFR Part 11 Compliance: Preparing Yourself for Inspection

  • Training
  • 90 Minutes
  • Global
FDA Warning Letters - Stop Fumbling your Response and Effectively Demonstrate Compliance - Product Thumbnail Image

FDA Warning Letters - Stop Fumbling your Response and Effectively Demonstrate Compliance

  • Training
  • 60 Minutes
  • Global
Process Validation for Medical Devices - The Regulatory Approach - Product Thumbnail Image

Process Validation for Medical Devices - The Regulatory Approach

  • Training
  • 90 Minutes
  • Global
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Regulatory Affairs in the biotechnology industry is the process of obtaining and maintaining approval from regulatory authorities for the development, manufacture, and marketing of biotechnology products. This includes the submission of applications, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs). Regulatory Affairs professionals are responsible for ensuring that biotechnology products comply with applicable laws and regulations. Regulatory Affairs professionals must have a thorough understanding of the regulatory environment and the ability to interpret and apply regulations to the development and marketing of biotechnology products. They must also be able to effectively communicate with regulatory authorities and other stakeholders. Companies in the Regulatory Affairs market in the biotechnology industry include Parexel, Quintiles, Covance, PRA Health Sciences, and Charles River Laboratories. Show Less Read more