Audits and Inspections

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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9/25/2023 - 12/4/2023

$645

Online

Closed

• SECTION ID:

  176191

• 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.

• INSTRUCTOR:

  Desai, Shrenik

• TEXTBOOKS:

  No information available at this time.

• POLICIES:

  No refunds after: 10/2/2023.
  

• NOTE:

• DATE & LOCATION:

  9/25/2023 - 12/4/2023
  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.