Live Webinar on Complaint Handling and Medical Device Reporting

Tuesday, Jun 21, 2016 at 10:00 AM to 11:30 AM EST

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Tuesday, Jun 21, 2016 at 10:00 AM to 11:30 AM EST

Description:

Complaint Handling and Medical Device Reporting are considered critical processes by the FDA in maintaining the public safety. Because they are so critical the FDA frequently inspects these areas in great detail. More importantly, complaints can be also be an early warning of issues with your products and customer problems. It is vital to have efficient and effective processes for managing, analyzing, trending, and reporting product problems. This webinar will cover the basics of complaint management and medical device reporting. Complaint management and MDRs are critical quality systems to your 3 key stakeholders – the customer, the regulators, and your business.

Objectives :

  • Understand regulations and expectations
  • Review enforcement case studies for lessons learned
  • Determine needed processes and procedures
  • Identify best practices
  • Understand the linkage between complaints, investigations, MDR reports, and CAPA
  • Preparing a plan for inspection readiness

Topics :

  • Overview and Definitions
  • FDA Expectations, Regulations
  • Lessons Learned and Enforcement Case Studies
  • Processes and Procedures
  • Reportability Criteria
  • Investigating a complaint or MDR
  • Linkages between Complaint Handling, MDRs, and CAPA
  • Common Mistakes and how to avoid them
  • Best Practices
  • Preparing for an FDA or NB Inspection
  • For more details :-https://www.grcts.com/GRC-90027

David ben

http://www.grcts.com

GRC Training Solutions is a premier training and solutions company that conducts high impact trainings in Corporate Governance, Regulatory Compliance, Quality Management and Risk Management. GRCs training modules are designed and facilitated by industry experts who possess a strong theoretical and working knowledge of the required regulatory compliance requirements. GRC Training Solutions uses Government and industry best practices and relevant software tools to help companies of all sizes accelerate business performance by helping them understand how to effectively operate within the various guidelines and regulatory frameworks.The training modules are designed for senior and mid level management and executives.

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