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.
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.
Upon completing this course participants should:
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:
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.
Upon completing this course participants should:
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:
This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.
Carolyn Troiano
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 …
How to Write Contracts for Procurement Professionals
Sunshine Act Reporting - Clarification for Clinical Research
How to Deal with Employees Who Love to Argue and Debate Eve…
Project Management for administrative professionals
ChatGPT and Project Management: Leveraging AI for Project M…
Onboarding Best Practices for 2025: Proven Strategies to Po…
Terminating Toxicity: Strategies For Leaders To Confidently…
Transform Data into Insights: A Beginners Guide to Excel Pi…
Reprogramming your mind for Corporate Excellence: 4 Steps t…
How to Write Effective Audit Observations: The Principles f…
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
Uplifting the Credibility of HR: How to Build the Credibili…
Performance of Root Cause Analysis, CAPA, and Effectiveness…
Bridging Generational Divides in the Workplace
Strategic Interviewing & Selection: Getting the Right Talen…
Onboarding Best Practices for Millennial and All Employees
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
FDA Audit Best Practices - Do's and Don'ts
Emotional Intelligence: Mastering the Emotions of Great Lea…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Accounting For Non Accountants : Debit, Credits And Financi…
Successful Strategies for FDA Expedited Pathways for Your D…
Regulation update Q1 2025: New and Proposed Regulations for…
Pay Transparency in Action: Strategies for Building Trust a…
Designing Employee Experiences to Build a Culture of Compli…
Developing and Implementing Quality Culture in the Organiza…
Excel Lookup Functions: VLOOKUP, HLOOKUP, and XLOOKUP Made …
Break Free from Toxicity: Reclaim Your Power and Peace
Tips and Techniques for Conducting an Effective Fraud Risk …
Physician Employment Agreements: Problem Areas that can be …
Measure the Effectiveness of Compliance Programs by Engagin…
FDA Regulation of Artificial Intelligence/ Machine Learning
Navigating 2025 Employment Laws: What Every Employer Needs …
Implementing an Effective Human Error Reduction Program
Cleaning Data without Complex Functions - A Course for Data…
Succession Plan for 2025: It's Not Just for Emergencies - I…
Employers Should Prepare for Immigration Raids in 2025! Thi…
Managing Toxic Employees: Strategies For Leaders To Effecti…
Using High-Performance Coaching for Managers to Address Per…
6-Hour Virtual Seminar on Learning the Highlights of Excel …
Principles & Practices for the Cybersecurity of Legacy Medi…