Training, Academy for GxP, Validation, Audit readiness

Rescop Academy
Rescop Academy can help you improve human behavior in environments subject to medical regulations. Rescop Academy has experienced trainers, who still work in practice, to help you increase the right knowledge at the right time.
Continuous Validation in Agile Training
Although Agile and Validation feel like a contradiction, Agile development can help you to efficiently validate your systems. Imagine a system can already be used partly after the first month of development in a validated state.
Rescop Academy Compliance Bootcamp
Within 3 days you will get an intensive training in GxP, Quality and Process Management, and GAMP 5. This training is meant to bring the trainee up-to-date with the latest guidelines and regulations in a short period of time. Multiple examples from practice and multiple cases will be used to relate the theory to practice. This training is meant for people who need to be brought up-to-date with current regulations and guidelines in a short period of time.
Quality and Process Management Workshop
To comply with regulations it is very important to have a solid Quality Management System. And maybe even more important: to have controls and measures in place to continuously improve the efficiency and effectiveness of this Quality Management System. It is not bad to make mistakes when lessons are learned from these mistakes and measures are implemented to prevent the same mistake occur again.

Rescop upcoming trainings

10 April 2018

Loes Kalkman - Rescop Principal Consultant is speaking at the GMP & GDP in three days

Description: Loes Kalkman - Determination of risks within Computerized System Validation.
The management of risks is an essential part of Computerized System Validation. This seems to be easy, but it turns out that a lot of risks are not considered which can jeopardize patient safety, product quality and quality of data. The following topics will be discussed:
· Organizational structure (QMS);
· Validation procedures (initial risk assessment with different types (technical/compliance);
· Methodology for applying risk assessment (FRA, FMEA);
· Project Management;
· 3 P's (risks): Process risks, Product risks, Project risks;
· Experience and validation knowledge of employees involved in validation activities.
For more information on the ‘GMP & GDP Driedaagse 2018’ visit www.gmp-driedaagse.nl/. Please note that the language used during this event is Dutch.
Golden Tulip hotel het Ampt van Nijkerk, Berencamperweg 4, 3861 MC Nijkerk

10 April 2018

Jos Nieuweboer - Rescop Principal Consultant is speaking at the GMP & GDP in three days

Description: Jos Nieuweboer - Criticality Analysis as QRM-tool.
A criticality analysis has the purpose to understand and control all product risks and can be summarized as the critical management of a drug product and its production process.
A critical analysis is:
· The combined knowledge of the ingredients, production process and of the final drug product;
· A risk based approach to determine which attributes are critical to the quality of the drug product and to the safety of the patient;
· The outcome of the analysis summarized in a single document (the criticality analysis report).
During the lecture the steps for the execution of a criticality analysis – and the attention points – will be explained.
For more information on the ‘GMP & GDP Driedaagse 2018’ visit www.gmp-driedaagse.nl/. Please note that the language used during this event is Dutch.
Golden Tulip hotel het Ampt van Nijkerk, Berencamperweg 4, 3861 MC Nijkerk

12 April 2018

Hans Lucas - Rescop Principal Consultant is speaking at the GMP & GDP in three days

Description: Hans Lucas - Practical guidance on the formulation of responses to Health Authority Inspection observations.
The formulation of responses to Health Authority Inspection observations is key to the outcome of an inspection. But often, the outcome of the inspection is already celebrated as the inspectors/investigators have left the premises and the focus of the organization has returned to the daily practice. The manner of wording of responses to the reported observations, often do not get the attention they should, leading to suboptimal results. In this workshop we will go into detail in the process of responding to observations from Health Authority Inspections by addressing;
· Roles and Responsibilities;
· Timing of activities both during the inspection as well as during the close-out;
· What are the elements of a good written response;
· Which means / sources do we have to our disposal.

For more information on the ‘GMP & GDP Driedaagse 2018’ visit www.gmp-driedaagse.nl/. Please note that the language used during this event is Dutch.

Golden Tulip hotel het Ampt van Nijkerk, Berencamperweg 4, 3861 MC Nijkerk

Rescop Academy can help you improve human behavior in environments subject to medical regulations through trainings and workshops

Rescop Academy has experienced trainers, who still work in practice, to help you increase the right knowledge at the right time.

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We believe that a single all-in-one platform should provide all aspects that a GxP Compliant company needs. With our product you can be compliant without any paper.

 

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Philips IT Testimonial

January 6th, 2016

The expectations were high, but these were all met during the training session. The audience was very different in levels of experience, but the trainer was very effective in switching from high level...

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DSM Testimonial

January 6th, 2016

We’ve done the Rescop Requirements Specification workshop and extended this with 1,5 day on-the-job training. This resulted in a clear and smart requirements specification, which was received as the-b...

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