GXP audits and inspections are conducted to identify non-compliances, but also regulatory weaknesses and the potential for non-compliance. This course introduces students to GXP audits and inspections, including internal audits/self-inspections, external supplier evaluations, continuous evaluation and for cause audits, and Mock Pre-Approval Inspections (PAI). Students will develop the skills to manage regulatory compliance audits and FDA inspections and will learn how to survive an inspection when things are not going well.
Course Number: BIOL-40356
Credit: 2.00 unit(s)
Related Certificate Programs: Quality Assurance and Control
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9/23/2024 - 12/2/2024
$645
Online
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CLASS TYPE:
Online Asynchronous.
This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
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POLICIES:
No refunds after: 9/30/2024.
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9/23/2024 - 12/2/2024
extensioncanvas.ucsd.edu
You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
There are no sections of this course currently scheduled. Please contact the Science & Technology department at 858-534-3229 or unex-sciencetech@ucsd.edu for information about when this course will be offered again.