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Results for tag: "CFR Part 11"

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

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

  • Webinar
  • January 2023
  • 90 Minutes
  • 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
Data Integrity Compliance for Computer Systems Regulated by FDA - Webinar (Recorded) - Product Thumbnail Image

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

  • Webinar
  • June 2022
  • 90 Minutes
  • Global
21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures - Webinar (Recorded) - Product Thumbnail Image

21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures - Webinar (Recorded)

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

Laboratory Inspection and Auditing (Recorded)

  • Training
  • March 2022
  • 1 Day
  • 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
  • March 2022
  • 90 Minutes
  • Global
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
FDA Compliance and Enforcement Trends focused on Data Integrity - Webinar (Recorded) - Product Thumbnail Image

FDA Compliance and Enforcement Trends focused on Data Integrity - Webinar (Recorded)

  • Webinar
  • September 2021
  • 90 Minutes
  • Global
Data Integrity: FDA/EU Requirements and Implementation (Recorded) - Product Thumbnail Image

Data Integrity: FDA/EU Requirements and Implementation (Recorded)

  • Training
  • January 2021
  • 2 Days
  • Europe
From
Aseptic Processing Overview and Validation - Webinar (Recorded) - Product Thumbnail Image

Aseptic Processing Overview and Validation - Webinar (Recorded)

  • Webinar
  • November 2019
  • 120 Minutes
  • Global
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
Analytical Method Validation and Transfer - Webinar (Recorded) - Product Thumbnail Image

Analytical Method Validation and Transfer - Webinar (Recorded)

  • Webinar
  • September 2019
  • 120 Minutes
  • Global
Best Practices for Preparing for an FDA Computer System Validation Audit - Webinar (Recorded) - Product Thumbnail Image

Best Practices for Preparing for an FDA Computer System Validation Audit - Webinar (Recorded)

  • Webinar
  • September 2019
  • 90 Minutes
  • Global
From
Trends in FDA Compliance and Enforcement for Regulated Computer Systems - Webinar (Recorded) - Product Thumbnail Image

Trends in FDA Compliance and Enforcement for Regulated Computer Systems - Webinar (Recorded)

  • Webinar
  • March 2019
  • 90 Minutes
  • Global
What exactly is required for 21 CFR Part 11, SaaS/Cloud, EU GDPR - Webinar (Recorded) - Product Thumbnail Image

What exactly is required for 21 CFR Part 11, SaaS/Cloud, EU GDPR - Webinar (Recorded)

  • Webinar
  • February 2019
  • 90 Minutes
  • Europe
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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