Effective Complaint Handling Procedures

Duration: 90 Minutes
Course Instructor

Charity Ogunsanya

$ 295
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

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This accredited training will provide attendees an understanding of the rules and regulations guiding complaint handling and complaint files within the life science industries.

Per 21 CFR Part 820.198, “Each manufacturer shall maintain complaint files‐establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit”. While a product manufacturer hopes to keep complaints to a minimum, chances are that complaints will be received at some point. A good complaint handling procedure is critical, it creates an opportunity to assess what can be done to make improvements on the affected product where possible.

Upon completion of this course, you will be able to:

  • Define, process, handle, evaluate, investigate, and manage a complaint investigation and files per 21 CFR Part 820.198.
  • List the various types of complaint classifications, and benefits of filing a complaint, and state the process flow of Complaint Processing at a Manufacturing Unit.
  • Process, analyze, approve, and take corrective actions based on the results of a complaint investigation.
  • Summarize FDA’s expectations as it applies to Complaint handling.
  • Review previous FDA‐483 Observations and Warning Letter Citations Related to Complaints.
  • Establish the content of a Complaint Handling and Investigation Standard Operating Procedure with an example of a complaint investigation report.
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This online training will benefit those involved in the manufacturing, processing, testing, and release of Pharmaceutical, Biotechnology, Drug, Biologics, Medical Device and In-vitro Diagnostics products amongst others.

Personnel and management within the various manufacturing Industries, especially that personnel with tasks associated with:

  • Quality Control
  • Quality Assurance
  • Manufacturing
  • Complaint Handlers
  • Supplier Quality Assurance
  • Regulatory Affairs
  • Shipping and Receiving
  • Auditors
  • Quality and Compliance
  • CAPA Investigators
  • Senior Management

Course Instructor

Charity Ogunsanya

Owner/CEO, Pharmabiodevice Consulting LLC

Charity Ogunsanya’s Courses


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