FDA's New Guidance on Data Integrity and Compliance
Duration: 90 Minutes
Faculty: Carolyn Troiano | Level: Intermediate | Course Id: 0009
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance.
While these practices have been employed, companies are being forced to do more work with fewer resources, leading to errors noted in citations, particularly in Warning Letters in the past 10 years. This has resulted in consequences including heavy fines and operational shut-downs.
Both FDA and industry recognize the need to review current practices to ensure they meet the standards for creating data with integrity and maintaining it as such throughout the entire life cycle. In this webinar, you will learn about these FDA trends in compliance and enforcement, as they relate to data integrity, and how to improve your practices to meet compliance requirements.
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines. This includes development of a company philosophy and approach, and incorporating it into an overall computer system validation program and plans for individual systems that are regulated by FDA. It also requires a recognition that Data Integrity issues continue to be a strong area of focus by FDA during inspection, and there are many examples and best practices that will be covered in this seminar to address them.
FDA’s guidelines for computerized systems were enacted in 1983, and very little has changed, other than technology, since that time, as it relates to validation. The premise for compliance is demonstrating clearly and completely that a computer system does what it purports to do. This means developing a very detailed set of unique and testable functional requirements, and creating a set of test scripts that will prove each requirement is met.
This webinar will describe the approach to determining the level and robustness of testing required, based on a thorough risk assessment of the system, which includes the likelihood, severity, and detectability of potential failures of the system to work as expected, and the mitigation to be applied, should the system fail. Along with system categorization, in accordance with GAMP 5 principles, and an evaluation of the complexity and application of the software, the attendee will understand how to develop the rationale they will include in the validation plan for the level of testing executed.
A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for validation, which will be discussed. We will also delve into the training requirements for users, testers, and those who will be the stewards of the system. All must be carefully documented.
Disaster Recovery and Business Continuity Planning will also be touched upon as key aspects of supporting the system in a validated state. Change control and periodic review will address the challenges of making certain that the system remains in control and is tested further according to any needs that arise from changes.
As FDA continues to evolve and change due to the many factors that influence the regulatory environment, companies must be able to adapt. New technologies will continue to emerge that will change the way companies do business. While many of these are intended to streamline operations, reducing time and resources, some unintentionally result in added layers of oversight that encumber a computer system validation program and require more time and resources, making the technology unattractive from a cost-benefit perspective.
Why should you Attend:
This webinar will help you understand in detail the application of FDA’s guidelines for Computer System Validation (CSV), which is in accordance with the System Development Life Cycle (SDLC) Methodology. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.
The SDLC will provide a framework for validation planning, allowing the attendee to understand all of the phases and deliverables required during validation. The end result will be a very well documented validation effort that will stand up to FDA scrutiny during an audit, and assure that the data housed and/or processed using the validated computer system will be maintained with great integrity.
It is important to remember that in addition to validating a computer system subject to FDA compliance, the system must be maintained in a validated state throughout its lifecycle, until the system is retired or otherwise no longer used. This webinar will describe the policies, procedures, training and other underlying support elements that are needed to ensure ongoing maintenance of a system in a validated state.
In addition, FDA has heavily focused its resources on inspection targeting Data Integrity (DI). During the past ten years, the percentage of Form 483 citations and Warning Letters with issues related to DI has increased dramatically, and continues to do so through 2019. We will provide the requirements related to DI, examples of FDA findings, and will cover the industry best practices that will help you mitigate this potential risk.
Areas Covered in the Session:
- Computer System Validation (CSV)
- System Development Life Cycle (SDLC) Methodology
- Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
- Data Integrity (DI)
- Validation Strategy, Planning and Execution
- System Risk Assessment
- GAMP 5 “V” Model and Software Categorization
- 21 CFR Part 11, FDA’s Guidance on Electronic Records/Electronic Signatures (ER/ES)
- Security, Access, Change Control and Audit Trail
- Criteria required to ensure data is created and maintained with integrity through its life cycle
- Policies and Procedures to support CSV and DI assurance
- Training and Organizational Change Management
- Current FDA Trends in Compliance and Enforcement
- Industry Best Practices and Common Pitfalls
Who Will Benefit:
Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GDPs:
- Medical Device
- Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
- Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA
Personnel in the following roles will benefit:
- Information Technology (IT) Analysts
- IT Developers
- IT Support Staff
- QC/QA Managers and Analysts
- Clinical Data Managers and Scientists
- Compliance Managers and Auditors
- Lab Managers and Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders using Computer Systems regulated by FDA
- Regulatory Affairs Personnel
- Consultants in the Life Sciences and Tobacco Industries
- Interns working at the companies listed above
College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements
Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.