In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.
WHY SHOULD YOU ATTEND?
The FDA governs the computer systems used to collect, analyze, transfer and report data that is in support of FDA regulated activities required for drug development and approval. FDA oversight is based on a Predicate Rule, known as “Good Practices,” or simply, “GxPs.”
Computer systems subject to GxP requirements must be thoroughly and appropriately validated in accordance with FDA’s guidance on computer system validation. This involves a rigorous set of phases and steps to ensure that, in the language of FDA, “a system does what it purports to do.”
The cost of adequately validating a GxP computer system can be high, and must be weighed against system risk and usage. GAMP 5 system classification guidelines can help ensure that a GxP system is categorized appropriately, based on the type of system and technology involved. Along with risk, system classification can provide a clear-cut pathway for validating a system, based on the appropriate level of testing and validation effort.
All types of data management and information systems will be discussed, including those based on in-house developed code, configurable systems and custom designed systems. Best industry practices and potential pitfalls in validating laboratory systems, along with examples, will be covered in detail.
Ongoing maintenance of the system in a validated state will be discussed, as well as governance, archival and retirement. These functions are critical to maintaining data in a state of integrity. We will also cover the establishment of a Data Governance Committee, the Charter, roles and responsibilities, and oversight. Such a committee is critical to successfully maintaining control over GxP systems and governing the state of integrity of the data housed in them.
We will also discuss the importance of applying good project management, business process re-engineering and organizational change management principles through the validation process and beyond.
AREA COVERED
- Data Integrity
- Data Governance
- FDA GxPs (GMPs, GLPs, GCPs, GDPs)
- Computer System Validation (CSV) Methodology
- System Development Life Cycle (SDLC) Framework
- Risk Management
- GAMP 5
- Compliance Strategy
- Cost vs. Compliance
- Industry Best Practices
- Policies and Procedures
- Training
- Leveraging Vendors
LEARNING OBJECTIVES
Upon completing this course participants should:
- Understand FDA requirements for Computer System Validation (CSV)
- Understand the System Development Life Cycle (SDLC) approach to validation
- Utilize GAMP 5 system classification and risk methodologies for categorizing systems and developing a validation pathway
- Understand how to build a complete validation strategy and program for GxP systems
- Know how to manage the validation process and create FDA-compliant documentation
- Know how to monitor a GxP system that is in production, governing the data and system through retirement
- Understand the roles and responsibilities required to validate a system and maintain it in a validated state in order to assure data integrity
- Know how to measure cost vs. compliance risk for a GxP system
- Understand good project management principles, incorporating business process re-engineering and organizational change management into the process
- Know the policies and procedures that must be developed and maintained to support the GxP system in operation, and the data you are governing
- Understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a GxP system
- Know about FDA trends in oversight and audit of GxP systems and how to keep abreast of these
WHO WILL BENEFIT?
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biotechnology, and tobacco. Functions that are applicable include research and development, clinical sample manufacturing, packaging, labeling, Quality testing, distribution, clinical testing and management, adverse events management and post-marketing surveillance.
You should attend this webinar if you are responsible for planning, executing or managing the implementation of any GxP system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:
- Data “Owners”
- Data “Stewards”
- Information Technology Analysts
- Information Technology Developers and Testers
- QC/QA Managers and Analysts
- Clinical Data Managers and Scientists
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- GLP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.
The FDA governs the computer systems used to collect, analyze, transfer and report data that is in support of FDA regulated activities required for drug development and approval. FDA oversight is based on a Predicate Rule, known as “Good Practices,” or simply, “GxPs.”
Computer systems subject to GxP requirements must be thoroughly and appropriately validated in accordance with FDA’s guidance on computer system validation. This involves a rigorous set of phases and steps to ensure that, in the language of FDA, “a system does what it purports to do.”
The cost of adequately validating a GxP computer system can be high, and must be weighed against system risk and usage. GAMP 5 system classification guidelines can help ensure that a GxP system is categorized appropriately, based on the type of system and technology involved. Along with risk, system classification can provide a clear-cut pathway for validating a system, based on the appropriate level of testing and validation effort.
All types of data management and information systems will be discussed, including those based on in-house developed code, configurable systems and custom designed systems. Best industry practices and potential pitfalls in validating laboratory systems, along with examples, will be covered in detail.
Ongoing maintenance of the system in a validated state will be discussed, as well as governance, archival and retirement. These functions are critical to maintaining data in a state of integrity. We will also cover the establishment of a Data Governance Committee, the Charter, roles and responsibilities, and oversight. Such a committee is critical to successfully maintaining control over GxP systems and governing the state of integrity of the data housed in them.
We will also discuss the importance of applying good project management, business process re-engineering and organizational change management principles through the validation process and beyond.
- Data Integrity
- Data Governance
- FDA GxPs (GMPs, GLPs, GCPs, GDPs)
- Computer System Validation (CSV) Methodology
- System Development Life Cycle (SDLC) Framework
- Risk Management
- GAMP 5
- Compliance Strategy
- Cost vs. Compliance
- Industry Best Practices
- Policies and Procedures
- Training
- Leveraging Vendors
Upon completing this course participants should:
- Understand FDA requirements for Computer System Validation (CSV)
- Understand the System Development Life Cycle (SDLC) approach to validation
- Utilize GAMP 5 system classification and risk methodologies for categorizing systems and developing a validation pathway
- Understand how to build a complete validation strategy and program for GxP systems
- Know how to manage the validation process and create FDA-compliant documentation
- Know how to monitor a GxP system that is in production, governing the data and system through retirement
- Understand the roles and responsibilities required to validate a system and maintain it in a validated state in order to assure data integrity
- Know how to measure cost vs. compliance risk for a GxP system
- Understand good project management principles, incorporating business process re-engineering and organizational change management into the process
- Know the policies and procedures that must be developed and maintained to support the GxP system in operation, and the data you are governing
- Understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a GxP system
- Know about FDA trends in oversight and audit of GxP systems and how to keep abreast of these
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biotechnology, and tobacco. Functions that are applicable include research and development, clinical sample manufacturing, packaging, labeling, Quality testing, distribution, clinical testing and management, adverse events management and post-marketing surveillance.
You should attend this webinar if you are responsible for planning, executing or managing the implementation of any GxP system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:
- Data “Owners”
- Data “Stewards”
- Information Technology Analysts
- Information Technology Developers and Testers
- QC/QA Managers and Analysts
- Clinical Data Managers and Scientists
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- GLP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.
Speaker Profile
Carolyn Troiano has more than 35 years of experience in computer system validation 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. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a …
Upcoming Webinars
California Meal and Rest Breaks: What You Dont Know Can Cos…
Responding to EEOC Discrimination Charges-What's Your Busin…
Implementing an Effective Human Error Reduction Program
Conflict Resolution - Prevent, De-escalate, Resolve
When Employees Travel: Wage and Expense Rules Employers Mus…
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Female to Female Hostility @Workplace: All you Need to Know
Form 1099-MISC and 1099-NEC Compliance Update 2024
Validation Statistics for Non-Statisticians
The Totally Organized Professional Is All About Outcomes
Why EBITDA Doesn't Spell Cash Flow and What Does
GAMP5, Second Edition and Alignment with Computer Software …
Project Management for Non-Project Managers - Scheduling yo…
Sunshine Act Reporting - Clarification for Clinical Research
Understanding the Math of HR… So You Can Show How HR Impact…
FFIEC BSA/AML Examination Manual: What Compliance Officers …
How to Address ISO's New Climate Change Requirements
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Re-imagine Finance & Accounting Made Simple. Three Webinars…
Stay Interviews: A Powerful and Low-Cost Employee Engagemen…
How To Conduct An Internal Harassment And Bullying Investig…
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
Managing Toxic & Other Employees Who Have Attitude Issues
Analytical Method Validation Under Good Laboratory Practic…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Do's and Don'ts of Giving Effective Feedback for Performanc…
Onboarding New Hires: Leverage the Potential of Artificial …
Project Management for HR, Administrative Professionals, an…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Using Behavior Based Interviewing for Finding the Best Matc…
How to Document Employee Discussions and Why it is Important
Stressed Out: How to Handle Conflict, Difficult People and …
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Best Practices for Working With Vendors and Suppliers
Understanding the Artificial Intelligence Landscape
Marketing to Medicare or Medicaid Beneficiaries - What You …
Accounting For Non Accountants : Debit, Credits And Financi…
Principles & Practices for the Cybersecurity of Legacy Medi…
Independent Contractor vs. Employee New Rule Issued by The …
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Kicking your Employee Retention Efforts into Overdrive: Sta…