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Results for tag: "Regulatory Affairs"

FDA Vs Health Canada - Product Thumbnail Image

FDA Vs Health Canada

  • Training
  • 60 Minutes
  • Canada
FDA Inspections: What Regulations Expect - Product Thumbnail Image

FDA Inspections: What Regulations Expect

  • Training
  • 90 Minutes
  • Global
Qualification of Contract Manufacturer Organizations Based on Practical Experience - Product Thumbnail Image

Qualification of Contract Manufacturer Organizations Based on Practical Experience

  • Training
  • 60 Minutes
  • Global
Lifecycle Approach to Analytical Methods with QbD Elements: Design, Development, Validation, Transfer - Product Thumbnail Image

Lifecycle Approach to Analytical Methods with QbD Elements: Design, Development, Validation, Transfer

  • Training
  • 120 Minutes
  • Global
PASSING A US FDA GMP INSPECTION: A-Z Guaranteeing a Pass the First Time through an FDA Inspection - Product Thumbnail Image

PASSING A US FDA GMP INSPECTION: A-Z Guaranteeing a Pass the First Time through an FDA Inspection

  • Training
  • 90 Minutes
  • United States
Establish and Maintain an Effective Supplier Qualification Program - Product Thumbnail Image

Establish and Maintain an Effective Supplier Qualification Program

  • Training
  • 60 Minutes
  • Global
Preparing for a U.S. FDA Audit - Product Thumbnail Image

Preparing for a U.S. FDA Audit

  • Training
  • 60 Minutes
  • United States
Preparing for FDA Pre-Approval Inspections - Product Thumbnail Image

Preparing for FDA Pre-Approval Inspections

  • Training
  • 60 Minutes
  • Global
Organization of Clinical Datasets in eCTD Submissions - Product Thumbnail Image

Organization of Clinical Datasets in eCTD Submissions

  • Training
  • 90 Minutes
  • Global
How to Prepare and Submit a Bullet Proof 510(k) Submission - Product Thumbnail Image

How to Prepare and Submit a Bullet Proof 510(k) Submission

  • Training
  • 60 Minutes
  • Global
Validation Requirements Based on ICH Q9 - Product Thumbnail Image

Validation Requirements Based on ICH Q9

  • Training
  • 90 Minutes
  • Global
Process Validation, planning, strategy, requirements, risk assessment, design description - Product Thumbnail Image

Process Validation, planning, strategy, requirements, risk assessment, design description

  • Training
  • 60 Minutes
  • Global
Implementing a GCP Vendor Qualification Program: Ensuring your vendors are in compliance with FDA requirements - Product Thumbnail Image

Implementing a GCP Vendor Qualification Program: Ensuring your vendors are in compliance with FDA requirements

  • Training
  • 75 Minutes
  • Global
Quality by Design: what the FDA wants, what you must do, how you can deliver to their expectations and what relief you can expect - Product Thumbnail Image

Quality by Design: what the FDA wants, what you must do, how you can deliver to their expectations and what relief you can expect

  • Training
  • 60 Minutes
  • Global
Develop, Execute and Enforce an Effective Validation Master Plan - Product Thumbnail Image

Develop, Execute and Enforce an Effective Validation Master Plan

  • Training
  • 60 Minutes
  • Global
How to prepare for the unannounced FDA compliance inspection - Product Thumbnail Image

How to prepare for the unannounced FDA compliance inspection

  • Training
  • 60 Minutes
  • Global
Hazard Analysis & Risk Management - New 14971 - Product Thumbnail Image

Hazard Analysis & Risk Management - New 14971

  • Training
  • 90 Minutes
  • Global
GCP Audit of Clinical Evaluations for Japan: Requirements and expectations from the revised Japanese PAL - Product Thumbnail Image

GCP Audit of Clinical Evaluations for Japan: Requirements and expectations from the revised Japanese PAL

  • Training
  • 60 Minutes
  • Japan
Preparing Compliant eCTD Submissions - Product Thumbnail Image

Preparing Compliant eCTD Submissions

  • Training
  • 60 Minutes
  • Global
The latest approach for complying with 21 CFR Part 11 - Product Thumbnail Image

The latest approach for complying with 21 CFR Part 11

  • Training
  • 60 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