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

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
Module 4: Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
Module 5: 21 CFR Part 11 and QMS Software Risk-Based Implementation
Module 6: 21 CFR Part 111 - FDA Inspections for Dietary Supplements - How to Prepare

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

Part 4 : Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
Instructor: John E Lincoln

Areas Covered in the Webinar:

• Learn how to identify “GxP” Systems
• Discuss the Computer System Validation (CSV) approach based on FDA requirements
• Learn about the System Development Life Cycle (SDLC) approach to validation
• Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
• Understand how to maintain a system in a validated state through the system’s entire life cycle
• Learn how to assure the integrity of data that supports GxP work
• Discuss the importance of “GxP” documentation that complies with FDA requirements
• Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
• Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures
• Know the regulatory influences that lead to FDA’s current thinking at any given time
• Learn how to conduct a risk assessment on computer systems that will provide the basis for developing a validation rationale
• Understand the need to include an assessment of a computer system’s size, complexity, business criticality, GAMP 5 category and risk, should it fail, to develop a cohesive and comprehensive validation rationale
• Learn how to assess risk, based on probability of occurrence, severity of impact, detectability and mitigation, along with technical and procedural controls that can help minimize risk
• Learn how to best prepare for an FDA inspection or audit of a GxP computer system
• Understand the importance of performing a thorough vendor audit to ensure oversight to the products and services they deliver
• Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
• Q&A

Part 5 : 21 CFR Part 11 and QMS Software Risk-Based Implementation
Instructor: John E Lincoln

Areas Covered in the Webinar:

• U.S. FDA's expectations / requirements
• Recent Data Integrity and Cybersecurity regulatory requirements
• Roles of Verification and Validation; Legal requirements; Recommended “best practices”
• The development of a 21-year long, field-tested FDA "Model"
• Basic development, implementation, use, and decommissioning expectations
• 21 CFR Part 11 (electronic records / signatures) requirements, and its implementation
• Expected Regulatory Deliverables
• Applicable standards and industry-recommended Guidelines

Part 6 : 21 CFR Part 11 and QMS Software Risk-Based Implementation
Instructor: Andy Swenson

Areas Covered in the Webinar:

• What to expect during an FDA inspection.
• What the FDA can inspect.
• What the FDA does not authority to inspect.
• What documents will be required.
• How to address the FDA.
• What expectations does the FDA have?
• How to reduce risk during an FDA inspection.

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