Risk-Driven Production and Process Validation Systems

Across FDA and EU (Merging QMSR and EU Annex 15)

Examine how risk analysis, validation planning, and execution activities can be connected across QMSR, ISO 13485, EU Annex 15, and global verification and validation expectations.

Team Discounts available

COURSE OVERVIEW & STRUCTURE

Validation planning quality shapes validation outcomes.

Organizations must decide how validation effort, risk analysis, resources, and documentation fit together across products, processes, software, equipment, and quality systems. Building consistent links between hazard analysis, validation planning, protocol selection, execution activities, and documentation expectations across multiple regulatory environments.

The session progresses from current regulatory expectations and recurring validation weaknesses into risk-based planning methods, Master Validation Plan development, validation execution models, software validation expectations, and practical approaches for coordinating equipment, process, software, and QMS activities within a unified validation system.

WHAT YOU’LL LEARN

Risk-Driven Validation Planning, Execution, and Global Alignment

DAY 1

Understanding QMSR impact on validation system expectations
Linking ISO 14971 hazards to validation planning depth
Structuring effective Master Validation Plan components
Identifying weaknesses behind recurring validation failures
Aligning validation scope with product and process risks
Applying practical planning models accepted by regulators

DAY 2

Applying DQ, IQ, OQ, and PQ strategically
Using ASTM E2500 with constrained operational resources
Building validation matrices to prevent missed requirements
Managing software validation and Part 11 expectations
Integrating cybersecurity controls within validation activities
Aligning FDA, EU Annex 15, and Asia requirements

WHO SHOULD ATTEND

Designed for professionals responsible for validation strategy, quality systems, process execution, software validation, or global product and equipment qualification activities.

Quality Assurance

Validation

Regulatory Affairs

Manufacturing

Engineering

Compliance

Operations

Prodcution

Product Development

Software Quality

Risk Management

Quality Management

FACULTY

John E. Lincoln

John E. Lincoln brings more than four decades of experience supporting FDA-regulated industries in product development, quality systems, risk management, software validation, equipment qualification, and process validation. His work with global manufacturers, combined with extensive involvement in ISO 14971, QMS remediation, and validation programs, provides practical insight into aligning risk-driven validation activities across FDA, QMSR, ISO 13485, and EU requirements.

AFTER YOU REGISTER

After you register your seat, our team organizes everything for you; from access to certification – “from one place”.

You receive a confirmation and your course appears instantly in your TalkFDA dashboard.
Your course page becomes your central hub where you can join the session, access materials, and manage your learning.
At the scheduled time, simply click Join Session and you’ll be connected to the live Webex session with the instructor.
After the session, the playback becomes available on the same course page so you can revisit important sections.
Complete the course and your certificate is unlocked automatically in your learning history.
Everything related to your course: access, materials, playback, and certification – lives in one place.

For Teams Seeking Deeper Implementation Support

This topic can also be delivered as a customized session through TalkFDA Elite Training Labs for organizations seeking structured, implementation-focused training aligned with their internal processes and quality systems.

Elite Training Labs sessions are tailored for teams and delivered in formats designed to support application, discussion, and practical integration beyond the live webinar format.

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