Description :
There are key regulatory documents global medical device companies must meet for the U.S. and the European Union / Common Market. And there are important differences. The cGMPs mandate Design Control and proof of compliance in the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement -- the Technical File or Design Dossier. Currently they serve different purposes, support different goals, but there are some similarities. And both are moving together in some important areas. Being aware of the similarities and differences can further concurrent development / documentation, and/or updates to both.
What are DMRs and DHRs relationship to DHFs, TF/DDs?
This 90 minute webinar will examine the existing and proposed requirements for the U.S. FDA's DHF and the EU MDD's TF/DD. This webinar will provide valuable assistance to all regulated device companies that need to ensure their DHFs, TFs/DDs and associated and derivative documentation meet their respective requirements. It also addresses current requirements as well as some changes on the horizon.
Areas Covered in the Session :
How to meet and document their differing requirements.
Required and desirable contents.
Areas requiring frequent re-evaluation / update.
Similiarities and differences, and future convergences and trends.
Typical DHF contents.
Typical Technical File or Design Dossier contents.
The importance and usefulness of the "Essential Requirements".
Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed.
Parallel approaches to development.
Where the Device Master Record / Device History Record "tie in".
Differing approaches to records audits by the U.S. FDA and an EU Notified Body.
Who Will Benefit:
The employees who will benefit include:
Senior management
Middle management
R&D
Engineering
Software
QA / RA
Manufacturing
Operations
Consultants
cGMP instructors
All personnel especially involved in device development, regulatory compliance and documentation.
Price Tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support@compliancetrainings.com
There are key regulatory documents global medical device companies must meet for the U.S. and the European Union / Common Market. And there are important differences. The cGMPs mandate Design Control and proof of compliance in the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement -- the Technical File or Design Dossier. Currently they serve different purposes, support different goals, but there are some similarities. And both are moving together in some important areas. Being aware of the similarities and differences can further concurrent development / documentation, and/or updates to both.
What are DMRs and DHRs relationship to DHFs, TF/DDs?
This 90 minute webinar will examine the existing and proposed requirements for the U.S. FDA's DHF and the EU MDD's TF/DD. This webinar will provide valuable assistance to all regulated device companies that need to ensure their DHFs, TFs/DDs and associated and derivative documentation meet their respective requirements. It also addresses current requirements as well as some changes on the horizon.
Areas Covered in the Session :
How to meet and document their differing requirements.
Required and desirable contents.
Areas requiring frequent re-evaluation / update.
Similiarities and differences, and future convergences and trends.
Typical DHF contents.
Typical Technical File or Design Dossier contents.
The importance and usefulness of the "Essential Requirements".
Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed.
Parallel approaches to development.
Where the Device Master Record / Device History Record "tie in".
Differing approaches to records audits by the U.S. FDA and an EU Notified Body.
Who Will Benefit:
The employees who will benefit include:
Senior management
Middle management
R&D
Engineering
Software
QA / RA
Manufacturing
Operations
Consultants
cGMP instructors
All personnel especially involved in device development, regulatory compliance and documentation.
Price Tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support@compliancetrainings.com
