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:
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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:
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
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