Risk Management Integration: ISO 14971 in a QMSR World
Risk files often satisfy submissions yet fail to guide design tradeoffs, validation focus, or resource allocation during active development and production decisions. This session organizes hazard analysis, FMECA, and Fault Tree outputs into a maintained Product Risk Management File that remains usable across design, manufacturing, and lifecycle updates.
Designed for professionals responsible for product safety rationale, documented risk controls, and cross-functional quality system execution.
📅 March 04, 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⌛ 90 Minutes
How This Session Is Structured
The program progresses from current ISO 14971 expectations into structured hazard analysis methods, then connects FMECA and Fault Tree outputs to file organization and review cadence. Templates, team roles, and maintenance cycles are outlined so risk documentation remains current and referenced in routine quality activities.
Key Areas Covered:
✔ ISO 14971:2019 updates and linkage to 21 CFR 820 QMSR expectations
✔ Defining hazards and hazardous conditions with clear documentation structure
✔ Organizing design, process, and use-related FMECA results for review
✔ Documenting causal paths through Fault Tree Analysis alongside other tools
✔ Suggested templates for Risk Management File, FMECA, and FTA
✔ Team involvement model: roles, timing, and review cadence
✔ Using the completed file for CAPA, investigations, and validation prioritization
Course Director
John E. Lincoln
John E. Lincoln brings over four decades of FDA-regulated industry experience, including extensive work developing and remediating ISO 14971-based risk management files. His background in quality assurance, regulatory affairs, design control, and QMS remediation positions him to address how risk documentation operates in real FDA and Notified Body environments, not just in theory.
What Happens After You Reserve Your Seat
Your registration is managed by our events team to ensure a coordinated and seamless experience.
- A confirmation email outlines onboarding details and next steps
- Access credentials are shared in advance so you are prepared before the session
- Handouts (where applicable) are provided ahead of time
- The training is delivered live via Webex with interactive participation and Q&A
- Certificates of completion are issued following the session
- For live + recording access, post-session availability is provided through TalkFDA
- Event support remains available for any access or logistics assistance
