ASEPTIC PROCESS SIMULATION

(APS)

YOU WILL LEARN

This course will provide a deep understanding about how challenging the aseptic manufacturing process is.

IF YOU ARE

You are a professional or a manager who needs to understand the technical fundamentals of aseptic processing or you are responsible for aseptic operations in a lab, pilot, or commercial setting

You are a Quality Systems/Assurance professional responsible for maintaining the integrity of aseptic systems

You design facilities/buildings and or commission or validate them.

You are a professional performing audits and assessments of aseptic processing

You are a Validation professional responsible for state-of-the-art validation of aseptic processes

You are a professional new to the aseptic world

YOU WILL LEARN

This course will provide a deep understanding about how challenging the aseptic manufacturing process is.

IF YOU ARE

You are a professional or a manager who needs to understand the technical fundamentals of aseptic processing or you are responsible for aseptic operations in a lab, pilot, or commercial setting

You are a Quality Systems/Assurance professional responsible for maintaining the integrity of aseptic systems

You design facilities/buildings and or commission or validate them.

You are a professional performing audits and assessments of aseptic processing

You are a Validation professional responsible for state-of-the-art validation of aseptic processes

You are a professional new to the aseptic world

DATE

22-23th Nov. 2022

Schedule

22th from 9:00 to 14:00
23th from 9:00 to 14:00

 

FORMAT

ON-Line

Hybrid model

Possibility of attending to our facilitires in Terrassa (Barcelona).
Where

Trainers

Claudia Sigg
Principal Consultant and founder of "Claudia Sigg GMP Consultancy"

Know our team

Want to know more about us?
OUR TEAM

DATE

22-23th Nov. 2022

Schedule

22th from 9:00 to 14:00
23th from 9:00 to 14:00

 

FORMAT

ON-Line

Hybrid model

Possibility of attending to our facilitires in Terrassa (Barcelona).
Where

Trainers

Claudia Sigg
Principal Consultant and founder of "Claudia Sigg GMP Consultancy"

Know our team

Want to know more about us?
OUR TEAM

Why we need to simulate the process before manufacturing.

What is an APS and how to design it.

First steps designing the protocol. How to decide the number of runs and the size of the batches.

Elements that need to be in the protocol.

Which are the interventions I need to simulate in the APS?

Importance of the personnel. How to achieve a correct qualification and training.

How to monitor the are correctly during the APS.

How to document the defective units in a run test during APS.

What to do with rejected units in the documentation.

Different medias: aerobic, anaerobic, generals, specific…etc

How to stablish the acceptance criteria.

Media fill failure – how to find the root cause

After the first validation, how to maintain a good control of the process, detect possible risks and evaluate continuously the performance of the process and the personnel.

Knowledge

Aquire new and useful concepts of aseptic facilities.

Global vision

Help in understanding the complexity of the aseptic manufacturing process. 

Why this course?

Critical thinking

Learn “how” and “why” things are done different.

Expertise

Teachers with experience in aseptical processing. 

NORMAL FEE

650
  •  

EARLY

BIRDS
600
  •  
DISCOUNT

STUDENTS

& EMERGING COUNTRIES
250
  •  

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