Anticipation and Expectations of a Medical OEM Design Control Audit 2014
15 Oct 2014
Webinar
Description
Topics
Dealing with the FDA and other authorizing bodies
Champion/Multi-functional team approach/responsibility
Design input/output
Phase by phase design process check list
Design changes
Design verification/validation
Design History File (DHF)
Design review
Gap analysis – data gathering for the design history files
Due-diligence
Design changes
Risk assessment
Planning to be prepared
Who should Attend
Attendees from medical device and regulated companies:
R&D and product development
End-users responsible for design control and technical files
Operations and plant management
Process engineers and managers
Remediation teams
Validation engineers
QC and Corporate Auditors
QA, Regulatory Affairs
Consultants
All team members who contribute to design history files, clinical, verifications/validations, risk management or technical files
Supplier management
Project managers
All Contract Manufacturers working in the medical industry
Product transfer engineers
Past Events
Anticipation and Expectations of a Medical OEM Design Control Audit 2014 - 15 Oct 2014, Webinar (43952)
Important
Please, check "Anticipation and Expectations of a Medical OEM Design Control Audit" official website for possible changes, before making any traveling arrangements
