In the United States, medical device firms are subject to compliance to the FDA regulations of device recalls, correction and removals. To achieve compliance and to remain compliant, it is critical to understand how to establish and maintain adequate procedures for medical device recalls, corrections and removals.
This webinar is intended to help device industry establish adequate procedures for medical device recalls, corrections and removals and further to provide practical, actionable, and sustainable perspectives by increasing awareness and familiarity of the applicable requirements.
This webinar will provide a great opportunity to adequately plan, develop and execute the relevant procedures in an effective, sustainable manner compliant with the recall requirements enforced by US FDA.
Areas Covered in the Session :
Laws And Regulations
Definitions
Regulatory Requirements For Medical Device Recalls
Voluntary Recalls
Health Hazard Evaluation
Recall Classification
Recall Strategy
Recall Letter, Envelope, and Return Response
Recall Effectiveness Check: Letter, Questionnaire, and Response
Recall Status Reports
Terminating a Recall
Public Notification
Mandatory Device Recall
Corrections And Removals
Recall Reporting
Documentation Requirements
Checklists
Enforcements: Case Studies
PASS-IT Recommendations: Best Practices
Who Will Benefit:
CEOs
VPs
Clinical Affairs
Regulatory Affairs
Quality Professionals
R&D
Complaint And Risk Management Personnel
Consultants
Contractors/Subcontractors
Other Interested Parties
Price List:
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
This webinar is intended to help device industry establish adequate procedures for medical device recalls, corrections and removals and further to provide practical, actionable, and sustainable perspectives by increasing awareness and familiarity of the applicable requirements.
This webinar will provide a great opportunity to adequately plan, develop and execute the relevant procedures in an effective, sustainable manner compliant with the recall requirements enforced by US FDA.
Areas Covered in the Session :
Laws And Regulations
Definitions
Regulatory Requirements For Medical Device Recalls
Voluntary Recalls
Health Hazard Evaluation
Recall Classification
Recall Strategy
Recall Letter, Envelope, and Return Response
Recall Effectiveness Check: Letter, Questionnaire, and Response
Recall Status Reports
Terminating a Recall
Public Notification
Mandatory Device Recall
Corrections And Removals
Recall Reporting
Documentation Requirements
Checklists
Enforcements: Case Studies
PASS-IT Recommendations: Best Practices
Who Will Benefit:
CEOs
VPs
Clinical Affairs
Regulatory Affairs
Quality Professionals
R&D
Complaint And Risk Management Personnel
Consultants
Contractors/Subcontractors
Other Interested Parties
Price List:
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
