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Results for tag: "Regulatory Affairs"

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
Drug Manufacturing Inspection Part III - Product Thumbnail Image

Drug Manufacturing Inspection Part III

  • Training
  • 120 Minutes
  • Global
Understanding FDA Import Alerts: What Are They and Recommendations For Removing Your Company And Products From An Alert - Product Thumbnail Image

Understanding FDA Import Alerts: What Are They and Recommendations For Removing Your Company And Products From An Alert

  • Training
  • 90 Minutes
  • Global
FDA Inspections: Understanding the Core Elements - Part I - Product Thumbnail Image

FDA Inspections: Understanding the Core Elements - Part I

  • Training
  • 120 Minutes
  • Global
Auditing the QC Microbiology Laboratory for FDA Compliance - Product Thumbnail Image

Auditing the QC Microbiology Laboratory for FDA Compliance

  • Training
  • 75 Minutes
  • Global
Pharmaceutical Water System Use & Monitoring - Product Thumbnail Image

Pharmaceutical Water System Use & Monitoring

  • Training
  • 90 Minutes
  • Global
FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance - Product Thumbnail Image

FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance

  • Training
  • 90 Minutes
  • Global
How to Prepare for and Conduct a Regulatory Audit - Product Thumbnail Image

How to Prepare for and Conduct a Regulatory Audit

  • Training
  • 60 Minutes
  • Global
Verification vs Validation in Regulated Industries - Product Thumbnail Image

Verification vs Validation in Regulated Industries

  • Training
  • 60 Minutes
  • Global
Proper Execution of Annual Product Reviews - Product Thumbnail Image

Proper Execution of Annual Product Reviews

  • Training
  • 60 Minutes
  • Global
Solving Statistical Mysteries - What Does FDA Want? - Product Thumbnail Image

Solving Statistical Mysteries - What Does FDA Want?

  • Training
  • 90 Minutes
  • Global
Import Basics to Avoid Detention - Product Thumbnail Image

Import Basics to Avoid Detention

  • Training
  • 60 Minutes
  • Global
Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities - Product Thumbnail Image

Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities

  • Training
  • 90 Minutes
  • Global
Computer System Validation (CSV) vs. Computer System Assurance (CSA): Aligning the Agile Methodology to the GAMP®5 "V" Model and System Development Life Cycle (SDLC) Methodology - Product Thumbnail Image

Computer System Validation (CSV) vs. Computer System Assurance (CSA): Aligning the Agile Methodology to the GAMP®5 "V" Model and System Development Life Cycle (SDLC) Methodology

  • Training
  • 120 Minutes
  • Global
Impact Assessment for Change Control - Product Thumbnail Image

Impact Assessment for Change Control

  • Training
  • 60 Minutes
  • Global
Residual Solvent Analysis According to USP <467> - Understanding and implementing the new USP chapter - Product Thumbnail Image

Residual Solvent Analysis According to USP <467> - Understanding and implementing the new USP chapter

  • Training
  • 60 Minutes
  • Global
Design History Files and Technical Files under US FDA and EU MDD - Product Thumbnail Image

Design History Files and Technical Files under US FDA and EU MDD

  • Training
  • 60 Minutes
  • United States, Europe United States, Europe
The FDA's final Medical Device Data System (MDDS) rule and its implications for currently regulated and unregulated vendors and providers - Product Thumbnail Image

The FDA's final Medical Device Data System (MDDS) rule and its implications for currently regulated and unregulated vendors and providers

  • Training
  • 65 Minutes
  • Global
How to do an Effective Hazard Analysis to meet FDA and ISO13485:2003 risk management requirements - Product Thumbnail Image

How to do an Effective Hazard Analysis to meet FDA and ISO13485:2003 risk management requirements

  • Training
  • 60 Minutes
  • 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
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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