Storytelling in Project Management for Validating FDA-Regulated Computer Systems: How to Captivate & Inspire the Team
Instructor:
Friday, October 31, 2025
11:00 AM PDT | 02:00 PM EDT
90 Minutes
Webinar ID: 503317
Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Overview:
Areas Covered in the Session:
Who Will Benefit:
By applying storytelling to FDA-regulated system validation, attendees will:
- Enhance team alignment - Everyone understands the "why" behind validation, not just the "how"
- Improve documentation quality - Narratives make requirements, risk assessments, and testing rationales clearer
- Boost stakeholder buy-in - Easier to get approvals, funding, and cooperation
- Make audits go smoother - Teams can speak confidently about the system’s purpose and compliance, reducing inspection stress
- Strengthen leadership skills - Build a personal brand as a PM who motivates through connection, not just directives
- Improve engagement and morale in system implementation/validation projects
- Communicate complex technical requirements in a way that resonates with different audiences
- Reduce misunderstandings that lead to costly rework or compliance risks
- Align their teams with FDA expectations under 21 CFR Part 11, Annex 11, and CSA principles
- Differentiate themselves as leaders who can inspire, not just manage
Areas Covered in the Session:
- The Role of Storytelling in Project Management
- Why humans respond better to stories than raw data
- Bridging the gap between technical validation steps and human motivation
- The Regulatory Context
- Overview of CSV & CSA
- How effective communication aligns with FDA and EU Annex 11 expectations
- The Core Elements of a Good Project Story
- Characters - Users, QA, IT, patients, regulators
- Conflict - Risks, compliance gaps, deadlines
- Resolution - How the project ensures safety, compliance, and efficiency
- Applying Storytelling to Validation Deliverables
- Making URS and risk assessments relatable
- Framing test plans and deviations as part of the story arc
- Linking validation to patient outcomes and business impact
- Practical Storytelling Techniques
- Using metaphors and analogies
- Structuring kick-off meetings around a compelling vision
- Turning metrics and timelines into "plot points"
- Stakeholder Engagement Through Story
- Adapting the narrative for executives, technical staff, QA, and end users
- Keeping momentum during long validation cycles
- Case Studies
- Examples showing storytelling improved project outcomes
- Common mistakes and how to avoid "fiction" that undermines compliance
- Action Plan
- Building your own validation project narrative
- Integrating it into project plans, training sessions, and audit readiness
- Q&A
Who Will Benefit:
- Project Managers
- Risk Specialists
- Information Technology (IT) Analysts
- IT Developers
- IT Support Staff
- IT Security Staff
- QC/QA Managers and Analysts
- Production Managers and Supervisors
- Supply Chain Managers and Supervisors
- Clinical Data Managers and Scientists
- Compliance Managers and Auditors
- Lab Managers and Analysts
- Computer System Validation Specialists
- GMP, GLP, GCP 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
Speaker Profile
Carolyn (McKillop) 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.
Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA's electronic record/electronic signature regulation.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA's electronic record/electronic signature regulation.