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Results for tag: "Regulatory Affairs"

Writing Excellent SOPs - Webinar (Recorded) - Product Thumbnail Image

Writing Excellent SOPs - Webinar (Recorded)

  • Webinar
  • May 2023
  • 90 Minutes
  • Global
From
A Journal of Drug Formulation, Development and Production - Product Thumbnail Image

A Journal of Drug Formulation, Development and Production

  • Journal Icon Journal
  • December 2025
  • 60 Pages
  • Global
From
4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future - Webinar (Recorded) - Product Thumbnail Image

4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future - Webinar (Recorded)

  • Webinar
  • May 2023
  • 240 Minutes
  • Europe
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
FDA Issues Final Rule on Symbols in Labeling - Webinar (Recorded) - Product Thumbnail Image

FDA Issues Final Rule on Symbols in Labeling - Webinar (Recorded)

  • Webinar
  • October 2021
  • 60 Minutes
  • Global
From
Verification vs. Validation in FDA Regulated Industries - Product Thumbnail Image

Verification vs. Validation in FDA Regulated Industries

  • Training
  • 60 Minutes
  • Global
Establishing an Effective & Pragmatic Vendor Qualification Program for cGMP Compliance in the Pharmaceutical Industry - Webinar - Product Thumbnail Image

Establishing an Effective & Pragmatic Vendor Qualification Program for cGMP Compliance in the Pharmaceutical Industry - Webinar

  • Webinar
  • 90 Minutes
  • Global
From
Supplier and Service Provider Controls: FDA Expectations - Product Thumbnail Image

Supplier and Service Provider Controls: FDA Expectations

  • Training
  • 120 Minutes
  • Global
How to Ensure Your Foreign Vendors are FDA Compliant: Conducting Vendor Audits, Monitoring, and Using Checklists - Product Thumbnail Image

How to Ensure Your Foreign Vendors are FDA Compliant: Conducting Vendor Audits, Monitoring, and Using Checklists

  • Training
  • 90 Minutes
  • Global
Raw Materials in Pharma/Biotech Production - Product Thumbnail Image

Raw Materials in Pharma/Biotech Production

  • Training
  • 60 Minutes
  • Global
Implementing a Robust Data Integrity Program - Product Thumbnail Image

Implementing a Robust Data Integrity Program

  • Training
  • 90 Minutes
  • Global
Handling OOS Test Results and Completing Robust Investigations - Product Thumbnail Image

Handling OOS Test Results and Completing Robust Investigations

  • Training
  • 90 Minutes
  • Global
505(b)(2) NDAs - Product Thumbnail Image

505(b)(2) NDAs

  • Training
  • 60 Minutes
  • Global
The Impact of ICH E6 R2 - Product Thumbnail Image

The Impact of ICH E6 R2

  • Training
  • 60 Minutes
  • Global
Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience - Product Thumbnail Image

Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience

  • Training
  • 60 Minutes
  • Global
Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements - Product Thumbnail Image

Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements

  • Training
  • 90 Minutes
  • United States, Europe United States, Europe
Remediating Water System Biofilm - What to Do After It Gets Ahead of You - Product Thumbnail Image

Remediating Water System Biofilm - What to Do After It Gets Ahead of You

  • Training
  • 90 Minutes
  • Global
Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment - Product Thumbnail Image

Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment

  • Training
  • 90 Minutes
  • Global
Avoid Documentation 'Time Bombs' - Product Thumbnail Image

Avoid Documentation 'Time Bombs'

  • Training
  • 60 Minutes
  • Global
How to Write Effective 483 and Warning Letter Responses - Product Thumbnail Image

How to Write Effective 483 and Warning Letter Responses

  • 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