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Results for tag: "Electronic Record"

How to Transition from Paper to Electronic Records in a Regulatory Environment - Product Thumbnail Image

How to Transition from Paper to Electronic Records in a Regulatory Environment

  • Training
  • 75 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
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
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
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
Objections to Agile and what you can do about them? - Product Thumbnail Image

Objections to Agile and what you can do about them?

  • Training
  • 60 Minutes
  • Global
Electronic Records & Electronic Signatures; 21 CFR Part 11 - Product Thumbnail Image

Electronic Records & Electronic Signatures; 21 CFR Part 11

  • Training
  • 90 Minutes
  • Global
Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies - Product Thumbnail Image

Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies

  • Training
  • 60 Minutes
  • Global
21 CFR Part 11 compliance for Electronic Medical Records - Product Thumbnail Image

21 CFR Part 11 compliance for Electronic Medical Records

  • Training
  • 60 Minutes
  • Global
Validation of Existing/ Legacy Computer Systems for FDA/EU Compliance - Product Thumbnail Image

Validation of Existing/ Legacy Computer Systems for FDA/EU Compliance

  • Training
  • 75 Minutes
  • Europe
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
Complying with 21CFR Part 11-Understanding the Role of Predicate Rules - Product Thumbnail Image

Complying with 21CFR Part 11-Understanding the Role of Predicate Rules

  • Training
  • 60 Minutes
  • Global
Data Integrity Compliance for Computer Systems Regulated by FDA - Product Thumbnail Image

Data Integrity Compliance for Computer Systems Regulated by FDA

  • Training
  • 90 Minutes
  • Global
21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures - Product Thumbnail Image

21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures

  • Training
  • 90 Minutes
  • Global
Best Practices in Preparation for an FDA Computer System Audit - Product Thumbnail Image

Best Practices in Preparation for an FDA Computer System Audit

  • Training
  • 90 Minutes
  • Global
FDA Compliance and Enforcement Trends focused on Data Integrity - Product Thumbnail Image

FDA Compliance and Enforcement Trends focused on Data Integrity

  • Training
  • 90 Minutes
  • Global
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software - Webinar (Recorded) - Product Thumbnail Image

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software - Webinar (Recorded)

  • Webinar
  • May 2023
  • 90 Minutes
  • Global
From
4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement - Webinar (Recorded) - Product Thumbnail Image

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement - Webinar (Recorded)

  • Webinar
  • October 2023
  • 240 Minutes
  • Global
From
6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA - Webinar (Recorded) - Product Thumbnail Image

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA - Webinar (Recorded)

  • Webinar
  • June 2023
  • 360 Minutes
  • Global
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The Electronic Record (ER) market within the context of Pharmaceutical Manufacturing is a rapidly growing sector. ER systems are used to store and manage data related to the production of pharmaceuticals, such as raw materials, production processes, and finished products. ER systems provide a secure and efficient way to store and access data, as well as to track and monitor production processes. ER systems also enable companies to comply with regulatory requirements and ensure product quality. ER systems are used by pharmaceutical manufacturers to improve operational efficiency, reduce costs, and ensure compliance with regulatory requirements. ER systems also enable companies to track and monitor production processes, as well as to store and access data related to the production of pharmaceuticals. Some companies in the ER market within the context of Pharmaceutical Manufacturing include Siemens, Rockwell Automation, ABB, Emerson, and Honeywell. Show Less Read more