Introduction

This webinar will discuss the regulatory requirements for handling complaints for both medical devices and pharmaceutical products as well as how change control, adverse event reporting and recalls apply, are interrelated, and are regulated.

This webinar will describe the process from the receipt of the complaint through its escalation to an eventual recall as well as navigating the challenges that can be experienced along the way.

Area Covered In The Webinar

  • Complaints defined
  • Governing regulations for both medical devices and pharmaceutical products
  • Documentation
  • Complaint handling process
  • Process timing
  • The relationship between the key elements – CAPA, change control, adverse event reporting, and recalls
  • Reportable events
  • Recall triggers
  • Recall classifications
  • Handling the challenges 
  • Records retention requirements

Why should you attend?

For any life science’s complaint, there are regulatory requirements that companies must follow. It is crucial to know and understand how these regulations apply and how compliance must be executed and assured. 

For example, it is required that companies maintain complaint files and have a have processes for receiving, reviewing, and evaluating those complaints. It is also required that those complaints be investigated in a precise, structured, and timely manner.

If not, when inspected by the FDA or other regulatory agencies, how each complaint is documented and handled could result in the issuance of a warning letter. 

The FDA as well as other global regulatory agencies have focused on complaint handling and CAPA execution during periodic inspections as a critical aspect of the regulatory process.  

Who Will Benefit

  • Regulatory Compliance
  • Quality Assurance 
  • Quality Control 
  • Regulatory Affairs 

ENROLLMENT OPTIONS

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Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and r Know More

Mr.Charles H Paul