Complaint Handling Requirements for CAPA, Change Control, Adverse Event Reporting, Recalls

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This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.

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