The DHF, Technical Documentation - Similarities, Differences and the Future
Are Your Design Documentation Files Ready for Global Scrutiny?
Don’t miss this opportunity to gain practical, actionable insights from a leading expert. | Meet Your Expert: John E. Lincoln 🔹 36+ Years in FDA-Regulated Industries 🔹 Expert in Quality Assurance, Regulatory Affairs, and QMS 🔹 Experienced Consultant for Startups to Fortune 100 Companies 🔹 Author and Speaker on CAPA, Risk Management, and FDA Compliance John’s extensive background in regulatory affairs and quality management has equipped him with unique insights into the challenges and opportunities of maintaining compliant documentation in the global market. |
| AGENDA | ||
DAY 1 (10 AM - 4 PM EST)
| DAY 2 (10 AM - 4 PM EST)
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WHAT YOU'LL LEARN IN THIS SEMINAR
As U.S. companies expand globally, meeting regulatory requirements for product design documentation becomes increasingly complex. The Design History File (DHF), mandated by FDA’s cGMPs, and the Technical Documentation (TD) required by the EU’s MDR, serve distinct purposes yet are converging in significant ways.
This comprehensive two-day seminar led by John E. Lincoln, an expert with 36+ years of experience in FDA-regulated industries, will demystify the similarities and differences between DHF and Technical Documentation. Gain clarity on the U.S. FDA’s and EU’s evolving regulations, learn how to maintain compliance across jurisdictions, and prepare for future trends in global device documentation.
✅ Comprehensive Understanding of DHF, DMR, DHR, and Technical Documentation requirements
✅ Insightful Analysis of differences and overlaps between FDA and EU regulations
✅ Practical Strategies for aligning your Design Control processes with global standards
✅ Future Trends in documentation that will impact your compliance strategy
✅ Audit Preparation – What to expect from both FDA and Notified Body audits
WHO SHOULD ATTEND
This seminar is essential for professionals involved in product design, quality management, and regulatory compliance in FDA-regulated industries, including:
🔹 Quality Assurance & Regulatory Affairs Managers
🔹 Research & Development Teams
🔹 Manufacturing & Engineering Professionals
🔹 Operations & Production Supervisors
🔹 Marketing & Documentation Specialists
Whether you’re new to DHF and Technical Documentation or seeking advanced insights, this seminar will provide the knowledge and tools you need to ensure global compliance and documentation excellence.
