Introduzione

Quality Culture is paramount in pharmaceutical manufacturing. This concept is becoming increasingly important for regulatory authorities and companies are investing resources in systems and personnel to promote particular attention to quality processes and product quality.
During the root cause analysis typically the 6M are considered (Method, Material, Machine, Milieu, Measurement and Manpower). Notably for “Manpower” this is not the endpoint to really understand the root cause of a problem/deviation.
Each individual working in manufacturing is called upon to embrace a quality-centric mindset in daily tasks, not merely following procedures mechanically but being proactive—identifying weaknesses, flagging inconsistencies, acknowledging mistakes, and suggesting improvements. In this way, every individual is accountable for the quality of the output, irrespective of their position or experience level, and should be entrusted with maximum responsibility for this crucial aspect.

This training is an awareness session to provide some insights into Quality Culture in pharmaceutical manufacturing and to realize how “Manpower” or “Human Error” may be further considered in understanding the true root cause of a deviation in pharmaceutical production processes. This will result in the choice and implementation of efficacious CAPAs able to minimize the risk that the deviation will re-occur.

  • Position of Human error in Root Cause Analysis and Functioning of the Brain
  • Categories of Human Error
  • Possible CAPA in relation to Human Error
  • Implications

Quality Assurance, QP, Quality Control, Production, Process Development/Engineering/ Validation/ Maintenance Department

 

Participant’s experience

At least 1 year working experience in the pharmaceutical, biotechnology or medical devices manufacturing.

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

Docente/i
Delphine Malisse
Info

Delphine Malisse

Head of Clinical QA at QbD Clinical, part of the QbD Group

Delphine currently leads the Quality department QbD Clinical, part of the QbD group. Before joining the company in 2021, she gained more than 20 years of experience in clinical research as well as in quality, in various companies.


Online Training – 1 module

17 October 2024 from 2:00 pm to 6:00 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 26 September 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.

Registrati
Early bird
Acquistabile fino al 26/09/2024
480,00
Ordinaria
Acquistabile fino al 16/10/2024
610,00
Freelance - Privato - Accademia - Pubblica Amministrazione
Acquistabile fino al 16/10/2024
360,00
Svuota

Francesca Archetti
Francesca Archetti
Marketing & Sales Specialist
Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Understand how Human Error can be further analyzed to better understand the true root cause
Risultato atteso
Know which main factors all contribute to Human Error
Risultato atteso
Learn strategies to minimize the Human Error occurrence

<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>