Internal and External GMP Audits

From February 16, 2023 - 09:00 to February 17, 2023 - 17:00
Biotech Training Facility

The course consists of a balanced combination of theory and practical training with specific focus on crucial issues that must be considered during the execution of an audit.The participants will also conduct an audit of the Biotech Training Facility's cleanrooms and facilities, whereby the participants will have ample opportunity to put all theory into practice.

The following topics will be discussed and practiced:

Different types of audits

  • Which types of audits are there?
  • What are the legal requirements for carrying out internal audits?
  • What are legal requirements for carrying out audits by third parties (for example: suppliers, contract manufacturing organizations, etc.)

Audit management

  • How to set up a yearly audit schedule
  • What is risk-based auditing? When should this be applied?
  • Management of CAPAs (Corrective and Preventive Actions)

Audit preparation

  • How to prepare efficiently for an audit
  • How to set up an audit agenda
  • Which standards/laws are applicable for which audits?

Audit tools and techniques

  • Which audit techniques and tools exist?
  • How and when to apply these techniques/tools
  • What types of questions should be used during an audit and when is the best time to use which question

Audit reporting

  • What are the most important aspects to consider for the registration of an audit observations?
  • What subjects should be part of an audit report?
  • How to assess an audit answer

Being audited

  • How to prepare an auditee for an audit
  • How to set up an efficient audit organization

More information and registration:

Did you know? No less than 15 Nobel Prize winners are linked to Leiden