Customer Testimonials
|
|
Subscribe NewsletterThe Design History File and the Technical File / Design Dossier
Product Id
:
600050
Overview: The DHF is a key element of Design Control under the GMPs, and is a major subject for review during a U.S FDA compliance audit.
The EU’s MDD Technical File / Design Dossier serve a different purpose, showing conformity to the MDD and associated applicable standards and the rationale for the CE mark. Each is subject to different requirements and expectations on the part of the reviewer / auditor. As such they are compiled differently, requiring differing mindsets and documentation.
The EU’s MDD Technical File / Design Dossier serve a different purpose, showing conformity to the MDD and associated applicable standards and the rationale for the CE mark. Each is subject to different requirements and expectations on the part of the reviewer / auditor. As such they are compiled differently, requiring differing mindsets and documentation.
Areas Covered in the Session:
- The U.S. FDA’s Design Control expectations
- The DHF’s defined purpose
- The EU MDD’s Technical File / Design Dossier’s defined purpose
- Similarities and differences – a key to understanding
- Some parallel approaches to file development
- The team approach
- Differing audit approaches by the FDA and your NB
- Living documents
- Q&A
Who Will Benefit:
- Senior management, project leaders
- Regulatory affairs
- Quality systems personnel
- Internal and supplier auditor personnel
- R&D and engineering staff
- Other personnel involved with activities, documentation and audits involving cGMP and/or ISO QMS activities