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Results for tag: "Regulatory Affairs"

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
CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE - Product Thumbnail Image

CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

  • Training
  • 90 Minutes
  • Global
CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule) - Product Thumbnail Image

CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)

  • Training
  • 90 Minutes
  • Global
CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps - Product Thumbnail Image

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

  • Training
  • 90 Minutes
  • Global
The Most Serious FDA 483s - How to Avoid Them - Product Thumbnail Image

The Most Serious FDA 483s - How to Avoid Them

  • Training
  • 90 Minutes
  • Global
CDISC Mapping 1: Specifications and FDA Requirements - Product Thumbnail Image

CDISC Mapping 1: Specifications and FDA Requirements

  • 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
Effective Deviation Investigators Under GMP - Product Thumbnail Image

Effective Deviation Investigators Under GMP

  • Training
  • 120 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
Utilizing ICH Guidelines for GCP Regulatory Compliance - Product Thumbnail Image

Utilizing ICH Guidelines for GCP Regulatory Compliance

  • Training
  • 60 Minutes
  • Global
Responding to FDA 483s and FDA Warning Letters - Best Practices - Product Thumbnail Image

Responding to FDA 483s and FDA Warning Letters - Best Practices

  • Training
  • 120 Minutes
  • Global
Vendor Qualification Auditing for FDA Computer System Compliance - Product Thumbnail Image

Vendor Qualification Auditing for FDA Computer System Compliance

  • Training
  • 90 Minutes
  • Global
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
Change Control for Computer Systems - strategies and tools for FDA compliance - Product Thumbnail Image

Change Control for Computer Systems - strategies and tools for FDA compliance

  • Training
  • 60 Minutes
  • Global
Equipment Qualification and Process Validation - Product Thumbnail Image

Equipment Qualification and Process Validation

  • 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