ITIL

Information Technology Infrastructure Library structure, philosophy and terminology will give you awareness of the importance of value creation when offering and delivering IT services to the customer.

CSV

CSX

Gain Foundational knowledge of cyber security with CSX. Get to know cyber security's key concepts and roles. Created by the industry's leading minds, ISACA 's® Cybersecurity NexusTM (CSX) is the only one-stop global resource for everything cyber security.

CSV

Aseptic Production

Aseptic production is of utmost importance in the manufacturing of sterile medication. This course provides a clear and applicable image of the current techniques and regulations in this field. Several different topics including general terms, regulations, techniques, qualification and validation, risks, cleaning and disinfection, people training, etc. will be explored in this training.

Production

Qualification of clean rooms

Clean rooms are crucial in the development of pharmaceutical products and are therefore strictly regulated. Qualification of these rooms involves the measurement of particles, microbiological quality, development and execution of an environmental monitoring program, etc. Additionally, interpretation, analysis and documentation of the results are part of the qualification process. All these topics will be treated in a 2-day training, followed by a workshop which will be focused on the management and processing of the collected data.

Production

CRISC

The Certified in Risk and Information Systems Control (CRISC) qualification is awarded to IT professionals who identify and manage risks through the development, implementation and maintenance of information systems (IS) controls. The candidates of this training should have three years of relevant work experience at least and pass a rigorous written exam.

CSV

QMS/ICH Q10

ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) quality concepts, includes applicable good manufacturing practice (GMP) regulations, and complements ICH "Q8 Pharmaceutical Development" and ICH "Q9 Quality Risk Management." This course focuses on the content of a pharmaceutical QMS and its consequences. Concepts such as CAPA's, deviations and complaints are discussed.

General

Audits & Assessments

During this interactive 3-day course the trainee will learn about the principles of auditing and the international standards that are used as references for auditing in quality assurance and quality management systems (ISO 9000-9004). The trainee will gain knowledge about practical audit aspects such as preparation for audit. Additionally, communicative aspects related to audits are also addressed like effective listening, interview types and reporting to management. Knowledge of ISO9001 is a prerequisite.

General

Method Validation

What are the key points for method validation? This course will introduce you to the ICH - guidelines on how to start validations of ISO 17025, ISO 15189 or GLP/GMP. You will get a clear overview of the validation of analytical - and test methods. Furthermore you will learn how to create and carry out a validation plan in your own laboratory.

Production

Lean Six Sigma Green Belt

Nowadays many companies want to improve and optimize their processes. That is why it is important to be acquainted with Lean Six Sigma to deliver added value.

Production

Q8 Pharmaceutical developments

The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. The ICH Q8 guideline provides guidance on how to use the knowledge gained through the application of scientific approaches and quality risk management to the development of a product and its manufacturing process. Topics such as Design Space, Quality by Design and Critical Quality Attributes are discussed.

Production

Sterilisation

Sterilisation is one of the key processes in most of the pharmaceutical industry. That is why it is of the utmost importance for QA and QC to understand the applicable legislations, the concepts (e.g. D-value, F0-value, SAL, etc.), and different methods of sterilisation (e.g. steam, dry heat, radiation,etc.).

Production

Prince2

As a (future) project manager it is important to have a solid 'academic' background in project management. Prince2 is the most used method in project management and many clients have their own project methodology which is a derivate of Prince2.

General

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Veerle Heyvaert — Resource Manager