Webinar On Medical OEM Design Control Audit: Expectations

Event Details

Time: February 26, 2015 from 1pm to 2pm
Location: Online
Street: 5939 Candlebrook Ct
City/Town: Mississauga
Website or Map: https://compliancetrainings.c…
Phone: 4169154458
Event Type: webinar
Organized By: Compliance Trainings
Latest Activity: Jan 16, 2015

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Event Description

Description :

This 60 minute webinar on a Design Control Audit by the FDA and other bodies will provide an understanding of what a medical OEM should anticipate during an audit during a design control audit. All medical device companies that are in need of examining their design control process should be aware of what to expect.

Areas Covered in the Session :

Champion/Multi-functional team approach/responsibility

Dealing with the FDA and other authorizing bodies

Phase by phase design process check list

Design input/output

Design verification/validation

Design changes

Design review

Design History File (DHF)

Due-diligence

Gap analysis – data gathering for the design history files

Risk assessment

Design changes

483 warning letters

Planning to be prepared

Who Will Benefit:

This webinar will provide valuable assistance and give a process to all medical device and regulated companies that need to prepare for an FDA or authorizing bodies audit in the future. The employees who will benefit include:

OEM and CMO quality managers

OEM and CMO quality engineers

End-users responsible for design control and technical files

R&D and product development

Process engineers and managers

Operations and plant management

Validation engineers

Remediation teams

QA, Regulatory Affairs

QC and Corporate Auditors

All team members who contribute to design history files, clinical, verifications/validations, risk management or technical files

Consultants