2015 - Webinar On Medical OEM Design Control Audit: Expectations

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
Project managers
Supplier management
Product transfer engineers
All Contract Manufacturers working in the medical industry
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-AT-compliancetrainings.com