GMP - (EN) Aseptic Production in the Pharmaceutical Industry

Type de cours
Durée totale
Logo Pharmaceutical Consultancy Services (PCS)
Note du fournisseur: starstarstarstarstar_half 9,2 Pharmaceutical Consultancy Services (PCS) a une moyenne de 9,2 (basée sur 5 avis)

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Description

The Training

In this two-day GMP training you will become acquainted with the different aspects of aseptic production. The GMP training highlights various aspects, critical cases and elements of aseptic production. It not only explores the GMP regulatory requirements but the practical implications as well.

After following this course, participants will have an overview of the critical aspects of aseptic production, can ask the right questions regarding the procedure and know where in the legislation and regulations information can be found regarding the different parts of aseptic production in the pharma.

With opportunities for the participants to ask individual questions, collaborate wit…

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Foire aux questions (FAQ)

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The Training

In this two-day GMP training you will become acquainted with the different aspects of aseptic production. The GMP training highlights various aspects, critical cases and elements of aseptic production. It not only explores the GMP regulatory requirements but the practical implications as well.

After following this course, participants will have an overview of the critical aspects of aseptic production, can ask the right questions regarding the procedure and know where in the legislation and regulations information can be found regarding the different parts of aseptic production in the pharma.

With opportunities for the participants to ask individual questions, collaborate with colleagues from the industry on case studies and jointly reflect on issues from daily practice.

Target audience

This course is aimed at those who want to acquire basic knowledge in a short time with regard to the critical factors of aseptic production of who want to increase their knowledge of this, such as:

  • People who work in the aseptic department themselves and need "background information", for example (main) operators.
  • Managers in production departments, such as supervisors and managers.
  • People who work in production departments in supporting functions such as a Technical Service.
  • Auditors of facilities where aseptic production is performed.
  • QA and Registration employees who want to gain more knowledge about aseptic production in the GMPs and in practice.

Content

Regulations

  • Current regulations and expectations in the future
  • Media simulations
  • Elements that must be described in some important documents Document types important for the review process

Hygiene Zoning / Clean Room Concept

  • Requirements for clean rooms
  • What different classes are there and what are the criteria per class?
  • Which activities must be carried out in which class?
  • How should a clean room complex be validated?
  • What is a pressure cascade and how should a pressure cascade be set up?
  • What is an isolator and what are the different types of isolators?
  • What are the rules of conduct in a clean room?
  • How should operators / cleaners be trained?
  • Do's and Don's in a clean room

Cleaning and Disinfection

  • What is the difference?
  • Which rules must be followed for efficient cleaning and disinfecting
  • How can disinfection methods be validated?

Introduction to Microbiology

  • What are microorganisms?
  • What do micro-organisms need to survive?
  • How can microorganisms be killed?

Testing and Release

  • Explanation of the different microbiological methods, including the sterility test, endotoxin determination, bioburden and identification of micro-organisms
  • What should be considered when releasing sterile products?

Sterilization Techniques

  • Description, application, validation and controls of;
    • Autoclaving
    • Dry heat treatment
    • Gas sterilization
    • Irradiation
    • Sterile filtration

Environmental Monitoring

  • Explanation about the different techniques and when which technology should be used How can an efficient trend analysis be set up?
  • What actions must be taken in the event of exceedances?
  • How can action and alert limits be set?

In-House Training

You can request an in-house training via Springest. You can also do this via the website of PCS. In-house training is the most interesting in terms of cost from around six participants. Maximum group size is 25 for the most efficient possible interaction and knowledge transfer. Groups above 25 people can be coordinated in consultation. PCS will contact you after request to go through details. A suitable offer will follow.

Program

The above content is an example of the content of the in-house training. The program can be changed as required. Note that changes can lead to a shortening or extension of the training program. No rights can be derived from the above content.

Completion

At the end of the training, participants who have attended the training as a whole will receive a certificate of participation. Accreditation at the KNMP or NVZA must be requested at least six weeks before the start of the training at PCS and may result in an additional fee.

PCS - The Practical Compliance Specialists since 1990

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    Il n'y a pour le moment aucune question fréquente sur ce produit. Si vous avez besoin d'aide ou une question, contactez notre équipe support.