Upon completion of this training program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, based on the System Development Life Cycle (SDLC) framework. They will have received the guidance on industry best practices necessary to develop a compliant and cost-effective validation program. They will understand the steps for validating laboratory systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs. Attendees will gain a good grasp of how to leverage these practices across all systems by creating a standardized program.
This webinar will benefit those responsible for planning, executing or managing the validation of laboratory computer systems governed by FDA regulations. Effective and compliant computer system validation is critical to any FDA-regulated organization. During the past 30 years, best practices have been developed that, if followed, can ensure laboratory computer systems are validated efficiently and in compliance with FDA regulations.
There is an enormous body of documentation and information available on computer system validation, which can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available. It will assist those responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.
This webinar will benefit those responsible for planning, executing or managing the validation of laboratory computer systems governed by FDA regulations. Effective and compliant computer system validation is critical to any FDA-regulated organization. During the past 30 years, best practices have been developed that, if followed, can ensure laboratory computer systems are validated efficiently and in compliance with FDA regulations.
There is an enormous body of documentation and information available on computer system validation, which can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available. It will assist those responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.
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 …
Surviving and Thriving Organizational Change and Loss: The …
Impact Assessment and Risk Management for Change Control
Excel Deep Dive: Advanced Tips & Techniques – A 3-hour Work…
How to Write Effective Audit Observations: The Principles f…
Coming Soon - New Minimum Salary Levels for Exempt Employee…
Marijuana: Compliance and Safety in the Workplace
FDA Regulation of Artificial Intelligence/ Machine Learning
Stressed Out: How to Handle Conflict, Difficult People and …
2025 Top Employment Regulations That Will Impact Employers!
How to Handle Workplace Conversations Around Politics and R…
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud,…
How to Give Corrective Feedback: The CARE Model - Eliminati…
Improving Employee Engagement & Retention Through Stay Inte…
SOPs - How to Write Them to Satisfy those Inspectors
Why EBITDA Doesn't Spell Cash Flow and What Does
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Marketing to Medicare or Medicaid Beneficiaries - What You …
Human Error Reduction Techniques for Floor Supervisors
Documenting Misconduct that Will Stand Up in Court
Trial Master File (TMF)/eTMF, & FDAs Draft Guidance for Ele…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Project Management for Non-Project Managers - How to commun…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Humane Layoffs: How to Let People Go with Compassion and De…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Sunshine Act Reporting - Clarification for Clinical Research
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Female to Female Hostility @Workplace: All you Need to Know
Onboarding is NOT Orientation - How to Improve the New Empl…
FDA Technology Modernization Action Plan (TMAP) and Impact …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Managing Toxic & Other Employees Who Have Attitude Issues
Building GMP Excellence: A Guide to Implementing Compliant …
Excel Power Skills: Master Functions, Formulas, and Macros …