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Results for tag: "CFR Part 11"

GAMP Data Integrity 21 CFR Part 11 Training Course - Product Thumbnail Image

GAMP Data Integrity 21 CFR Part 11 Training Course

  • Training
  • 90 Minutes
  • Global
Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts - Product Thumbnail Image

Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts

  • Training
  • 90 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
FDA Computer System Validation Training: Pack of 6 Training Courses - Product Thumbnail Image

FDA Computer System Validation Training: Pack of 6 Training Courses

  • Training
  • 8 Hours
  • Global
FDA Data Integrity Training: Pack of 6 Training Courses - Product Thumbnail Image

FDA Data Integrity Training: Pack of 6 Training Courses

  • Training
  • 9 Hours
  • Global
21CFR Part 11 - Predicate Rules Compliance - Product Thumbnail Image

21CFR Part 11 - Predicate Rules Compliance

  • Training
  • 60 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
21 CFR Part 11 and QMS Software Risk-Based Implementation - Product Thumbnail Image

21 CFR Part 11 and QMS Software Risk-Based Implementation

  • Training
  • 60 Minutes
  • Global
Practical Application of 21 CFR Part 11 - Product Thumbnail Image

Practical Application of 21 CFR Part 11

  • Training
  • 60 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
21 CFR Part 11 compliance under the Obama administration - Product Thumbnail Image

21 CFR Part 11 compliance under the Obama administration

  • Training
  • 60 Minutes
  • Global
Validating spreadsheets: strategies for satisfying FDA requirements - Product Thumbnail Image

Validating spreadsheets: strategies for satisfying FDA requirements

  • Training
  • 90 Minutes
  • Global
Utilizing ICH Guidelines for GCP Regulatory Compliance - Product Thumbnail Image

Utilizing ICH Guidelines for GCP Regulatory Compliance

  • Training
  • 60 Minutes
  • Global
Validation Master Planning - The Unstated Requirements - Product Thumbnail Image

Validation Master Planning - The Unstated Requirements

  • Training
  • 90 Minutes
  • Global
Computer System Validation and Part 11 Compliance - Product Thumbnail Image

Computer System Validation and Part 11 Compliance

  • Training
  • 60 Minutes
  • Global
How to Comply with FDA Regulations for Tobacco-Related Products: Computer System Validation, 21 CFR Part 11, & Data Integrity - Product Thumbnail Image

How to Comply with FDA Regulations for Tobacco-Related Products: Computer System Validation, 21 CFR Part 11, & Data Integrity

  • Training
  • 90 Minutes
  • Global
Good Documentation Practice (GDP) and FDA Validation Compliance for Regulated Computer Systems and Data - Product Thumbnail Image

Good Documentation Practice (GDP) and FDA Validation Compliance for Regulated Computer Systems and Data

  • Training
  • 90 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
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
IT Governance and Controls for FDA & SOX compliance: The single solution - Product Thumbnail Image

IT Governance and Controls for FDA & SOX compliance: The single solution

  • Training
  • 60 Minutes
  • Global
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The CFR Part 11 market is a subset of the pharmaceutical manufacturing industry that focuses on the implementation of electronic records and electronic signatures (ERES). This market is driven by the need for companies to comply with the FDA's regulations for the use of ERES in the pharmaceutical industry. The CFR Part 11 market is composed of companies that provide software, hardware, and services to help pharmaceutical companies comply with the FDA's regulations. These companies provide solutions such as document management systems, audit trails, and secure data storage. Companies in the CFR Part 11 market include MasterControl, Validation Technologies, and PharmaLex. Show Less Read more