In today’s global medical device market, manufacturers must be prepared to meet diverse and evolving inspection expectations across major regulatory jurisdictions.
This 4-hour virtual workshop will provide a practical, cross-regional view of medical device inspections conducted by the U.S. FDA, EU notified bodies MDSAP, China NMPA, Korea MFDS, and Japan PMDA. Regulatory authorities and oversight bodies in the United States, European Union, China, Korea, and Japan each apply distinct requirements, priorities, and inspection practices—yet all expect manufacturers to demonstrate robust quality systems, effective risk management, and ongoing regulatory compliance.
Through real-world case studies and practical examples, attendees will learn how to prepare for inspections and respond to observations and strengthen post-inspection remediation efforts. The workshop is designed to help regulatory, quality, and compliance professionals build a more globally aligned inspection-readiness strategy and reduce compliance risk across multiple markets.
Participants will explore how these regulators approach inspections, what they commonly focus on, and where manufacturers most often encounter compliance challenges.
The program will examine key topics such as:
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Differences in inspection scope, style, and frequency across regions
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Current inspection trends, enforcement actions, and regulatory developments
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Key documentation and quality system expectations
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Effective responses to observations, findings, and follow-up actions
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Inspection readiness strategies for global organizations
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Lessons learned from real-world case studies and recent inspection experiences
Designed for professionals in regulatory affairs, quality assurance, compliance, and operations, this workshop will help attendees better understand both the differences and commonalities among major global inspection frameworks. By the end of the workshop, participants will be better equipped to prepare for inspections, align internal processes across markets, and respond effectively to regulatory findings.
Learning Objectives
Upon the conclusion of the program, participants will be able to:
- Differentiate the key inspection priorities, methodologies, and common deficiencies identified by the FDA, MDR, China NMPA, Korea MFDS, and Japan PMDA.
- Develop comprehensive inspection readiness strategies tailored to the specific expectations of each regulatory authority, including documentation review, personnel training, and key elements of quality system.
- Implement practical strategies for managing inspections, particularly remote audits, by understanding their unique approach to documentation, communication, and on-site/remote interactions.
- Formulate effective responses to inspectional observations (e.g., Form 483s, NMPA Rectification Notices), including root cause analysis and corrective and preventive action (CAPA) implementation.
Who Should Attend?
- Regulatory Affairs
- QA
- Compliance
- Startups
- Executives
- Investors
Audience Learning Level:
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Agenda
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speakers
Grace F. Palma, MBA
Christine Forcier
