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Results for tag: "CFR Part 11"

If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices - Webinar (Recorded) - Product Thumbnail Image

If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices - Webinar (Recorded)

  • Webinar
  • July 2021
  • 90 Minutes
  • Global
From
Best Practices in Preparation for an FDA Computer System Audit - Webinar (Recorded) - Product Thumbnail Image

Best Practices in Preparation for an FDA Computer System Audit - Webinar (Recorded)

  • Webinar
  • June 2021
  • 90 Minutes
  • Global
From
21 CFR Part 11 - Compliance for Electronic Records and Signatures - Webinar (Recorded) - Product Thumbnail Image

21 CFR Part 11 - Compliance for Electronic Records and Signatures - Webinar (Recorded)

  • Webinar
  • June 2021
  • 60 Minutes
  • Global
From
Verification vs Validation-Product, Process or Equipment and QMS Software - Webinar (Recorded) - Product Thumbnail Image

Verification vs Validation-Product, Process or Equipment and QMS Software - Webinar (Recorded)

  • Webinar
  • May 2021
  • 90 Minutes
  • Global
From
3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11 - Webinar (Recorded) - Product Thumbnail Image

3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11 - Webinar (Recorded)

  • Webinar
  • April 2021
  • 180 Minutes
  • Global
From
Data Integrity - US FDA Requirements - Webinar (Recorded) - Product Thumbnail Image

Data Integrity - US FDA Requirements - Webinar (Recorded)

  • Webinar
  • March 2021
  • 90 Minutes
  • United States
From
3-Hour Virtual Seminar on What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections - Webinar (Recorded) - Product Thumbnail Image

3-Hour Virtual Seminar on What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections - Webinar (Recorded)

  • Webinar
  • March 2021
  • 180 Minutes
  • Global
From
Data Integrity and Governance for Computer Systems Regulated by FDA - Webinar (Recorded) - Product Thumbnail Image

Data Integrity and Governance for Computer Systems Regulated by FDA - Webinar (Recorded)

  • Webinar
  • February 2021
  • 90 Minutes
  • Global
From
Good Documentation Practices to Support FDA Computer System Validation - Webinar (Recorded) - Product Thumbnail Image

Good Documentation Practices to Support FDA Computer System Validation - Webinar (Recorded)

  • Webinar
  • March 2020
  • 90 Minutes
  • Global
From
Implementing a Robust Data Integrity Program - Webinar (Recorded) - Product Thumbnail Image

Implementing a Robust Data Integrity Program - Webinar (Recorded)

  • Webinar
  • October 2019
  • 120 Minutes
  • Global
2-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11 - Webinar (Recorded) - Product Thumbnail Image

2-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11 - Webinar (Recorded)

  • Webinar
  • March 2019
  • 2 Hours
  • Global
From
How to Write Effective 483 and Warning Letter Responses - Webinar (Recorded) - Product Thumbnail Image

How to Write Effective 483 and Warning Letter Responses - Webinar (Recorded)

  • Webinar
  • March 2019
  • 90 Minutes
  • Global
6-Hour Virtual Seminar on Good Documentation and Record Keeping Best Practices (FDA & EMA) - Webinar (Recorded) - Product Thumbnail Image

6-Hour Virtual Seminar on Good Documentation and Record Keeping Best Practices (FDA & EMA) - Webinar (Recorded)

  • Webinar
  • January 2019
  • 6 Hours
  • Global
From
3hr Virtual Seminar - Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA/EMA, USP and ICH - Webinar (Recorded) - Product Thumbnail Image

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

  • Webinar
  • October 2018
  • 180 Minutes
  • Global
FDA's enforcement of 21 CFR part 11 compliance - Webinar (Recorded) - Product Thumbnail Image

FDA's enforcement of 21 CFR part 11 compliance - Webinar (Recorded)

  • Webinar
  • September 2018
  • 90 Minutes
  • Global
FDA's New Enforcement of 21 CFR Part 11 - Webinar (Recorded) - Product Thumbnail Image

FDA's New Enforcement of 21 CFR Part 11 - Webinar (Recorded)

  • Webinar
  • September 2018
  • 75 Minutes
  • Global
3-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11 - Webinar (Recorded) - Product Thumbnail Image

3-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11 - Webinar (Recorded)

  • Webinar
  • August 2018
  • 180 Minutes
  • Global
Project Management for Computer Systems Validation and 21 CFR 11 - Annex 11 - Webinar (Recorded) - Product Thumbnail Image

Project Management for Computer Systems Validation and 21 CFR 11 - Annex 11 - Webinar (Recorded)

  • Webinar
  • August 2018
  • 90 Minutes
  • Global
Computer System Validation: Step-by-Step - Webinar (Recorded) - Product Thumbnail Image

Computer System Validation: Step-by-Step - Webinar (Recorded)

  • Webinar
  • August 2018
  • 90 Minutes
  • Global
Excel Spreadsheets for 21 CFR 11 Compliance - Webinar (Recorded) - Product Thumbnail Image

Excel Spreadsheets for 21 CFR 11 Compliance - Webinar (Recorded)

  • Webinar
  • August 2018
  • 90 Minutes
  • Global
From
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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