Data Integrity and Data Governance for Computer Systems Regulated by FDA
MP3 Download / On Demand Webinar Duration 90 Minutes
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Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
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.
Why Should 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.
- 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
- Information Technology Analysts
- Information Technology Managers
- QC/QA Managers
- QC/QA Analysts
- Clinical Data Managers
- Clinical Data Scientists
- Analytical Chemists
- Compliance Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Managers
- Manufacturing Supervisors
- Supply Chain Specialists
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
- Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
- Auditors engaged in internal inspection
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.
Midlothian, Virginia, United States
Award winning FDA Compliance Speaker for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity.
My experience includes 34+ years in IT/ Business, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries.
My successes include building and managing teams and business units at multiple “greenfield” sites in the pharmaceutical, biotechnology and IT consulting industries, as well as in the public sector. I have weathered numerous layoffs, mergers and acquisitions, and demonstrated my very strong leadership skills in helping staff get through difficult times.
Our Participants Testimonial
The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )
Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.
Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )
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I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )
Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma
The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )
Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals
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About World Compliance Seminars (WCS)
World Compliance Seminars (WCS) is one stop solution for all your pharmaceutical, biotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIH, EMA, as well as numerous European based national regulatory bodies.
These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical Compliance, Process Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.
The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.