Introduzione

Pharmaceutical manufacturing sites must meet the requirements stated in the Good Manufacturing Practice (GMP). Ensuring control of the entire manufacturing process is one of the paramount aspects.

To get such a level of confidence in the production process, it is necessary to perform proper statistical analysis on data that is available or can be acquired during the process development and during production itself.

In the training, we will go through the basics of statistical analysis, applying statistical methods to some case studies and learning how to interpret results. Moreover, the training will provide you with tools to make data-driven decisions and evaluate where a process can be improved and where it is already under control.

Content:

  • Basic statistics
  • Measurement system analysis
  • Process Validation Guidance, focus on:
    • Control Charts
    • Capability analysis

The course is aimed at non-statisticians and have a practical and applicative approach.

The workshop will be interactive, presenting and discussing several case studies and exercises to apply the theoretical statistical concepts described.

Anyone working in the pharmaceutical or biotechnology industry, willing to learn more about statistical process control, in particular personnel working in Process Development, Process Engineering, Quality Assurance, Quality Control and Validation departments.

Participant experience:

Entry level, no experience required.

The online workshop will be a mixture of theoretic presentations, case studies and practical examples.

Docente/i
Daan Claessens
Info

Daan Claessens

Validation & Qualification Consultant, QbD
Daan got the Master’s degree in Chemical Engineering in 2013 and he is specialized in (bio)chemical process control. He has been working as Qualification & Validation engineer for QbD since the start of his career, where he has been collaborating with several pharmaceutical and biotech companies.

Online Training – 1 module

Module 1 | 02 July 2024 from 02:00 pm to 06:00 pm CEST

After the registration, you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 480,00* (until 11 June 2024)

Ordinary: € 610,00*

Freelance – Individual – Academy – Public Administration**: € 360,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee

The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Understand basic statistics
Risultato atteso
Produce reliable data
Risultato atteso
Draw reasonable conclusions regarding process parameters and variables
Risultato atteso
Understand what is expected from regulations regarding process control

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>