GxP Audits – See How to Go About Them: Modul 1-3 (10668)

Course details

Course GxP Audits – See How to Go About Them: Modul 1-3
Trainer Cristina Almeida
The Force
Period 09/04/24 — 10/04/24
State scheduled
Category Webinar series
Language English
Free places
Fee €795.00 plus VAT.
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Auditing is an important task and responsibility of cultivation companies, manufacturers, distributors, quality control laboratories, and warehouse/logistics providers to regularly monitor the GxP compliance and serves as an improvement tool.  

Audits include self-inspections, but also external audits of service providers (e.g. CMO and/or QC labs) as well as suppliers of active pharmaceutical ingredients and other products/materials, where audits can play an important role in the qualification process.   

Since an audit is a systematic, independent and documented process for obtaining evidence and a respective objective assessment (with a view to determining the extent to which the audit criteria are met), it needs to be well planned, prepared and executed, and afterwards correctly and objectively evaluated and reported.  

In the first 3 training modules, the goal is to provide the basic/general tools for conducting all kinds of audits and to offer in-depth insights into the practice of auditing:  

Module 1 – GxP audit: Basic Knowledge and Methods  
Module 2 – Planning and Execution of GxP Audits 
Module 3 – After the Audit: Evaluation, Report and Final Closure 


Program

Tuesday, 09.04.2024 Module 1 from 09:00 - 10:30 am 

Module 1 – GxP Audit: Basic Knowledge and Methods 

  • Audit definition, goals, and general processes/phases. 
  • Audit types (internal, external vs. official regulatory inspections; onsite or remote audit) and scopes (e.g., GACP, GDP, GMP, GLP). 
  • Competence profile of the auditor: auditor qualifications and responsibilities. Questioning techniques for auditors. Psychology of audits: how to handle critical situations. 
  • Basic audit techniques. Typical topics for an audit (general and specific according to the respective requirements). System audit versus compliance audit. 
  • Real practical situations.  
  • Quiz about module 1.  

Tuesday, 09.04.2024 Module 2 from 10:45 - 12:15 pm 

Module 2 – Planning and Execution of GxP Audits 

  • Planning, preparation, and announcement (audit agenda): the correct start.   
  • Execution of audits: opening meeting, tour visit, documentation review and audit closure. 
  • Reasonable sequence of topics for different audits.  
  • Real practical situations. 
  • Quiz about module 2.  

Wednesday, 10.04.2024 Module 3 from 09:00 - 10:30 am 

Module 3 – After the Audit: Evaluation, Report and Final Closure 

  • Compilation, evaluation, and interpretation of observations. Systematic versus punctual mistakes. Finding root causes. Classification of the deficiencies.  
  • How to write an audit report? Mandatory content of the audit report. Modular structure of reports. Executive summary. 
  • Evaluation of the CAPA plan and follow-up.  
  • Final audit closure. 
  • How to decide/define the re-audit? 
  • Real practical situations. 
  • Quiz about module 3.  

Duration: approx. 90 minutes per module
Language: English | Handout: English

...more from your speaker Dr. Cristina Almeida...

Webinars allow you to conveniently attend training sessions and technical presentations from anywhere at any time. They are the perfect way to keep up to date with the latest knowledge without much effort. You are also welcome to ask the speaker questions after the webinar.


Note on contingent call-off: If you book the entire series, three parts per participant will be deducted.

For group enquiries, please contact us directly at info@alphatopics.de.

Course times

Weekday Time
Tuesday 09:00 - 12:15
Wednesday 09:00 - 10:30

Location

Virtual online event via GotoWebinar

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