Webinar On Complaint Handling & Medical Device Reporting (MDR)

As a domestic or foreign medical device manufacturer including an importer and user facility, you are subject to regulatory requirements for complaint handling and medical device reporting (MDR) in the US.

FDA frequently cites in 483s upon establishment inspections and subsequently warning letters issued to the firms as follows.

"…Your failure to establish and maintain adequate complaint handling or medical device reporting procedures…”

This presentation is intended to help global medical device firms and stakeholders adequately implement US FDA-compliant medical device complaint handling and medical device reporting (MDR) systems.  Even if it is believed that the similar or relevant procedures have been implemented in your firms, it is time to ensure all aspects of the requirements are under check to be adequate and compliant. To achieve compliance and to remain compliant with the FDA-compliant complaint handling and medical device reporting, it is imperative that the firms accurately understand, interpret, and implement the requirements for handling all complaints (electronic, written, or ORAL) and medical device reporting to be better sustainable as evident from a recent case. 

In this 60-min presentation, the speaker will guide you through the details of the required elements to successfully implement the medical device complaint handling and medical device reporting systems so that you can ensure your firms adequately establish and maintain the applicable systems in a PASS-IT manner.

Areas Covered in the Session :

Applicable Laws and Regulations

Definitions

Requirements for Complaint Handling

Requirements for Medical Device Reporting

Applicable Processes and Procedures

Key Elements in the Procedures: Complaint Handling and MDR

What to Do When a Complaint Is Received

What/How/When to Investigate a Complaint

Complaints Investigation and Documentation

Medical Device Reporting

How to Determine Reportable Events

Establishing Reportability Criteria

Additional Documentation Requirements for MDR

Mistakes and How to Avoid Mistakes and 483s

Relationships between Complaint Handling, MDR, and CAPA

Enforcement Case Studies

Improving Our Awareness and Continuous Improvement

Speaker’s PASS-IT suggestions and recommendations

Who Will Benefit:

Complaint Managers

Regulatory Affairs

Quality

Clinical Affairs

R&D engineers and scientists, managers, directors, VPs

Compliance and Legal Affairs

CRO

Auditors and Consultants

Senior Management

Anyone Interested in Medical Device Complaint Handling Systems

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@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1357