Design History Files and Technical Files under US FDA and EU MDD
Instructor:
John E Lincoln
Product ID: 701175
- Duration: 60 Min
Areas Covered in the seminar:
- The U.S. FDA’s DHF’s defined purpose;
- The EU’s MDD’s defined purpose;
- Similarities;
- Differences;
- Parallel approaches to developing the documents;
- When to involve teams;
- What to expect from FDA and NB audits;
- Approaches to ensure they remain “living (and useful) documents”.
Who will benefit:
- Senior management, project leaders
- Regulatory affairs
- Quality systems personnel:FDA and ISO / MDD / CE-marking compliance
- R&D and engineering staff
- All charged with new product development, regulatory submissions, initiating / overseeing regulatory compliance.
John E. Lincoln, consultant, has successfully designed, written over 50 ISO 14971-compliant Risk Management Files / Reports, including FMECA and FTA analysis, many in response to FDA 483 observation, which have subsequently passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development / design control projects; with over 24 years of experience, primarily in the medical device industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP.
More Training By Experts
- 10 Steps to Effective Risk Analysis for US FDA and ISO 14971 Compliance
- Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
- Change Control - Implementation and Management
- Validation for FDA and ISO 13485 Compliance: Pack of Two Courses
- Medical Device QSR (21 CFR Part 820), Design Control, Hazard Analysis Under ISO 14971 and ICH Q9: Pack of 3 Courses
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