Internal & External GMP Audits

Hands-on training in conducting a GMP audit. Learn to use your senses when auditing! An audit training whereby you practice by performing an inspection in a manufacturing facility with real cleanrooms and utilities.

Duration
2 days
Course fee
€ 1495 (excl. VAT)

Short description

The course is made up of a balanced combination of theory and practical training with specific focus on the various important issues that must be taken into account during the execution of an audit.

During the training the participants will carry out an actual audit of the Biotech Training Facility's cleanrooms and facilities, whereby the participants will have ample opportunity to practice with the training tools that have been covered and discussed.

Throughout the training the following points will be raised and practiced:

Different types of audits

  • What 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 techniques/tools

  • What audit techniques/audit 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 take into account when recordingaudit observations?
  • What subjects should be written up in an audit report?
  • How to assess an audit answer

Being audited

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

Objectives

On completion of these courses the participants will be able to:

  • Execute the correct actions during the preparation of an audit
  • Set up an audit agenda
  • Apply the right audit technique
  • Carry out an audit
  • Create an audit report including audit observations

Target group

  • QA staff that plan to or already do carry out internal and/or external audits
  • Production, QC staff and other pharmaceutical personnel that plan to or already do carry out internal and/or external audits
  • Staff members who are or will be responsible for GMP aspects during due diligence audits

Program

Day 1

 

Theory

• The audit process
• The regulatory requirements for audits
• Set up a yearly audit program
• Set up an audit agenda
• Prepare the auditee

 

Practical

• Setting up an audit agenda
• Application of risk based audits

Day 2

 

Theory

• Audit techniques
• Different types of audits
• How to write an audit report
• Analyze, classify and record audit observations
• Evaluate audit answers

 

Practical

• Performing an actual audit of the BTF cleanrooms and facilities
• Recording the audit observations

Sign up

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Interested in signing up a group of people for this course?

Please contact our Business Development team:
info@biotechtrainingfacility.nl
+31 (0)88 2830100

Need help? Have a question or a suggestion maybe?

Drop us a line below or call us on
+31 (0) 88 283 01 00.

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