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Results for tag: "Regulatory Affairs"

Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile Production FDA & ICH Expectations and Guidance (Recorded) - Product Thumbnail Image

Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile Production FDA & ICH Expectations and Guidance (Recorded)

  • Training
  • July 2024
  • 90 Minutes
  • Global
3hr Virtual Seminar - Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA/EMA, USP and ICH - Product Thumbnail Image

3hr Virtual Seminar - Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA/EMA, USP and ICH

  • Training
  • 3 Hours
  • Global
GMP Auditing of Active Pharmaceutical Ingredients (APIs) and Excipient Suppliers (Recorded) - Product Thumbnail Image

GMP Auditing of Active Pharmaceutical Ingredients (APIs) and Excipient Suppliers (Recorded)

  • Training
  • March 2024
  • 6 Hours
  • Global
From
The US FDA QMSR Transition - 21 CFR 820 and ISO 13485 (Recorded) - Product Thumbnail Image

The US FDA QMSR Transition - 21 CFR 820 and ISO 13485 (Recorded)

  • Training
  • February 2024
  • 90 Minutes
  • United States
From
Enhancing Quality Oversight in Pharmaceutical Contract Manufacturing Organizations (Recorded) - Product Thumbnail Image

Enhancing Quality Oversight in Pharmaceutical Contract Manufacturing Organizations (Recorded)

  • Training
  • August 2023
  • 2 Days
  • Global
From
Surviving an FDA Sponsor Inspection - Training for Success - Product Thumbnail Image

Surviving an FDA Sponsor Inspection - Training for Success

  • Training
  • 105 Minutes
  • Global
The 510(k) Mod Program, Breakthrough Technologies, and STeP (Recorded) - Product Thumbnail Image

The 510(k) Mod Program, Breakthrough Technologies, and STeP (Recorded)

  • Training
  • August 2024
  • 90 Minutes
  • Global
Understanding and Preparing for FDA Pharmaceutical Inspections (Recorded) - Product Thumbnail Image

Understanding and Preparing for FDA Pharmaceutical Inspections (Recorded)

  • Training
  • June 2024
  • 90 Minutes
  • Global
Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance (Recorded) - Product Thumbnail Image

Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance (Recorded)

  • Training
  • June 2024
  • 90 Minutes
  • Global
Assess Impact For Supplier Change Notices (Recorded) - Product Thumbnail Image

Assess Impact For Supplier Change Notices (Recorded)

  • Training
  • June 2024
  • 60 Minutes
  • Global
eCTD Submissions - Fundamentals and Process (Recorded) - Product Thumbnail Image

eCTD Submissions - Fundamentals and Process (Recorded)

  • Training
  • February 2024
  • 60 Minutes
  • Global
From
Data Integrity by Design and Pharma 4.0: Next-Gen Techniques to Approach GxP Systems, and FDA Compliance (Recorded) - Product Thumbnail Image

Data Integrity by Design and Pharma 4.0: Next-Gen Techniques to Approach GxP Systems, and FDA Compliance (Recorded)

  • Training
  • December 2023
  • 2 Days
  • Global
From
Audit Like the FDA - Effective Internal Audit Program (Recorded) - Product Thumbnail Image

Audit Like the FDA - Effective Internal Audit Program (Recorded)

  • Training
  • July 2023
  • 2 Days
  • Global
From
Pharma 4.0: A Different Way to Approach GxP Products, Systems, and Compliance with FDA (Recorded) - Product Thumbnail Image

Pharma 4.0: A Different Way to Approach GxP Products, Systems, and Compliance with FDA (Recorded)

  • Training
  • April 2023
  • 2 Days
  • Global
From
Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters (Recorded) - Product Thumbnail Image

Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters (Recorded)

  • Training
  • October 2021
  • 2 Days
  • Global
From
Supplier Quality Assurance Agreements: Why a General Supply Agreement May Not Be Enough with Some Suppliers - Webinar (Recorded) - Product Thumbnail Image

Supplier Quality Assurance Agreements: Why a General Supply Agreement May Not Be Enough with Some Suppliers - Webinar (Recorded)

  • Webinar
  • May 2019
  • 90 Minutes
  • Global
Preparing for an FDA Inspection - Product Thumbnail Image

Preparing for an FDA Inspection

  • Training
  • 60 Minutes
  • Global
Brazilian Regulatory System for FDA Regulated Industry: Pack of 10 Training Courses - Product Thumbnail Image

Brazilian Regulatory System for FDA Regulated Industry: Pack of 10 Training Courses

  • Training
  • 16 Hours
  • Brazil
Become Specialized with Advertising, Promotion, and Labeling FDA Compliance - Training Bundle - Product Thumbnail Image

Become Specialized with Advertising, Promotion, and Labeling FDA Compliance - Training Bundle

  • Training
  • 4 Hours
  • Global
Software Design Controls in Life Sciences Applications - Product Thumbnail Image

Software Design Controls in Life Sciences Applications

  • Training
  • 4 Hours
  • 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