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Results for tag: "CFR Part 11"

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
Aseptic Processing and Validation Course (Recorded) - Product Thumbnail Image

Aseptic Processing and Validation Course (Recorded)

  • Training
  • January 2024
  • 2 Days
  • Global
From
21 CFR Part 11 Data Integrity Training for CSV, CSA, SaaS/Cloud - How to Reduce Costs for Compliance (Recorded) - Product Thumbnail Image

21 CFR Part 11 Data Integrity Training for CSV, CSA, SaaS/Cloud - How to Reduce Costs for Compliance (Recorded)

  • Training
  • January 2024
  • 2 Days
  • 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
3-Hour Virtual Seminar on Computer System Validation (CSV) vs. Computer Software Assurance (CSA) - Following a Waterfall vs. Agile Methodology - Webinar (Recorded) - Product Thumbnail Image

3-Hour Virtual Seminar on Computer System Validation (CSV) vs. Computer Software Assurance (CSA) - Following a Waterfall vs. Agile Methodology - Webinar (Recorded)

  • Webinar
  • October 2023
  • 3 Hours
  • Global
From
CSV Boot Camp - 3-Day Certification Course (Recorded) - Product Thumbnail Image

CSV Boot Camp - 3-Day Certification Course (Recorded)

  • Training
  • September 2023
  • 3 Days
  • Global
From
Computer System Validation (CSV/CSA), 21 CFR Part 11, Data Integrity/Privacy Compliance for FDA-Regulated Systems (Recorded) - Product Thumbnail Image

Computer System Validation (CSV/CSA), 21 CFR Part 11, Data Integrity/Privacy Compliance for FDA-Regulated Systems (Recorded)

  • Training
  • September 2023
  • 3 Days
  • Global
From
Supplier And Contract Manufacturer Management (Recorded) - Product Thumbnail Image

Supplier And Contract Manufacturer Management (Recorded)

  • Training
  • August 2023
  • 2 Days
  • Global
From
Lifecycle Management of Analytical Methods and Procedures : Current Trends & Your Questions Answered (Recorded) - Product Thumbnail Image

Lifecycle Management of Analytical Methods and Procedures : Current Trends & Your Questions Answered (Recorded)

  • Training
  • August 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
Introduction to Computer System Validation (Recorded) - Product Thumbnail Image

Introduction to Computer System Validation (Recorded)

  • Training
  • March 2023
  • 3 Hours
  • Global
From
Medical Device Process Validation Training for Professionals - Webinar (Recorded) - Product Thumbnail Image

Medical Device Process Validation Training for Professionals - Webinar (Recorded)

  • Webinar
  • March 2023
  • 90 Minutes
  • Global
From
Computer System Validation for Cloud and COTS Applications-Live Online Training (Recorded) - Product Thumbnail Image

Computer System Validation for Cloud and COTS Applications-Live Online Training (Recorded)

  • Training
  • March 2023
  • 3 Days
  • Global
FDA Modernization and Restructuring of the SDLC for Computer System Validation and Compliance - Webinar (Recorded) - Product Thumbnail Image

FDA Modernization and Restructuring of the SDLC for Computer System Validation and Compliance - Webinar (Recorded)

  • Webinar
  • December 2022
  • 90 Minutes
  • Global
Laboratory Inspection and Auditing (Recorded) - Product Thumbnail Image

Laboratory Inspection and Auditing (Recorded)

  • Training
  • March 2022
  • 1 Day
  • Global
From
Lifecycle Management of Analytical Methods and Procedures according to new USP and ICH Guidelines (Recorded) - Product Thumbnail Image

Lifecycle Management of Analytical Methods and Procedures according to new USP and ICH Guidelines (Recorded)

  • Training
  • December 2021
  • 2 Days
  • Global
From
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH) (Recorded) - Product Thumbnail Image

Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH) (Recorded)

  • Training
  • October 2021
  • 2 Days
  • Global
From
21 CFR Part 11, Data Integrity, and Computer System Validation (Recorded) - Product Thumbnail Image

21 CFR Part 11, Data Integrity, and Computer System Validation (Recorded)

  • Training
  • September 2021
  • 1 Day
  • Global
From
Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA - Webinar (Recorded) - Product Thumbnail Image

Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA - Webinar (Recorded)

  • Webinar
  • October 2019
  • 3 Hours
  • Global
From
21 CFR 11 Compliance for Excel Spreadsheet - Product Thumbnail Image

21 CFR 11 Compliance for Excel Spreadsheet

  • Training
  • 90 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