Friday 28th February, 2014
9:00am to 6:00pm
Lecture 1: Complaint Handling:
What are the elements of an effective complaint management
How does risk management influence complaint handling
What are the responsibilities of other departments?
What is the best way to train customer contact employees?
What steps would the FDA expect to see the departments taking that sorts out potential MDRs, product complaints and other reportable events?
What and how do you perform trending?
What are examples of how companies trend and analyze service calls and product complaints?
Understand how and why CAPA is tied in to product complaint investigation
What is an appropriate complaint handling system in a risk-based post-market environment?
How do you audit a complaint handling system?
From your audits, how do you judge that your complaint handling system is effective?
Assignment of responsibility
Manufacturer should develop a method for maintaining records of complaints and investigations that: is functional and economical, meets company needs, and meets FDA requirements and expectations
Identify designated complaint handling unit
Instructions for documenting complaint information
Process for evaluating complaints
Process for investigating complaints
Identify and process MDR's
How to process customer returns
Records and trend analysis
Examples of tools currently being used to conduct investigations
How far and in-depth do you go with your investigations
What are current FDA "hot" buttons and trends, benchmarks and best practices for investigations
How to become a "good" investigator and the emphasis on closed-loop investigations
Written Procedures: Designated Complaint Handling Unit, Training and Records
Recent Enforcement Actions
Lecture 2: Medical Device Reporting
Introduction to Medical Device Reporting
What are the key terms, definitions and forms?
MDR procedures and processes
What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
How do you manage international reporting requirements under your complaint handling system?
Consider the relationship between MDRs and Risk Assessments
Lecture 3: Exercise and Recap of Day 1
Exercise on Product Complaints/Complaint Handling
Regulatory Affairs & Compliance Consultant,
David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies via remediation, compliance engineering support, post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing; and working with Notified Bodies, and AR's. David manages regulatory problems (e.g. AE's, MDRs, Agency enforcement, complaints/investigations, field alerts/recalls) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems.
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