FDA 21 CFR Part 11 Training: Concept, Compliance and Auditing

Instructors: Angela Bazigos, Don Hurd
Product ID: 706435
  • Duration: 4 Hrs

Training CD / USB Drive

$699.00
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Read Frequently Asked Questions

The GxP regulations which are established by the United States and Food and Drug Administration (FDA) are published in the Code of Federal Regulations. These regulations are divided into Titles, Code of Regulation, and Sections. Whenever a regulation is cited, the title tells where the regulation is published.

Employees in regulated organizations must be trained on the regulations pertaining to their roles or specific area periodically because they keep evolving and changing.

Lack of adequate training of employees is one of the most frequently cited deviations in FDA inspectional observations. Employees of regulated companies must understand what regulations apply, what the interpretations of the regulations are and the FDA requirements.

CFR Part 11 compliance training is essential for companies and individuals to maintain a competitive advantage and avoid putting themselves in the penalty box. To build a compliance culture, your employees must understand compliance with the regulatory requirements.

Help yourself and your organization to stay abreast of the CFR Part 11 compliance by ordering this training kit today.

All Modules:

Module 1: Practical Application of 21 CFR Part 11
Module 2: 21 CFR 11 Compliance for Excel Spreadsheet
Module 3: Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts

Part 1 : Practical Application of 21 CFR Part 11
Instructor: Don Hurd

Areas Covered in the Webinar:

  • Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
  • Good "Variable" Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • Validation Strategy that will take into account the system risk assessment process
  • FDA's 21 CFR Part 11 (Electronic Records/Electronic Signatures) Guidance
  • Strategic Approach to ER/ES Compliance
  • Policies and Procedures to support GxP compliance with 21 CFR Part 11
  • Training and Organizational Change Management best practices to help move the organization in a new direction
  • Industry best practices and common pitfalls

Part 2 : 21 CFR 11 Compliance for Excel Spreadsheet
Instructor: Angela Bazigos

Areas Covered in the Webinar:

  • Requirements for Excel Spreadsheets
  • FDA Part 11 Validation Guidance
  • Compliance Problems with Spreadsheets
  • Design Specifications for 21 CFR 11 Compliance
  • Documentation for Part 11
  • Future Trends in 21 CFR 11 Compliance for Excel Spreadsheets

Part 3 : Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts
Instructor: Angela Bazigos

Areas Covered in the Webinar:

  • Introduction, Historical Perspective, and Definitions
  • Computerized System Validation Master Plan
  • Validation Plan
  • Developer Assessment
  • Requirements, Design, and Configuration Specifications
  • Validation Testing
  • Procedures/Archival/Traceability
  • Validation Summary Report
  • Commissioning Memo
  • System Decommissioning/Retirement
  • Questions & Answers
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Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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