Webinar on Best Practices for Medical Device Recalls

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

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1355