Workshops

Rescop Academy workshops are meant to train small groups on a specific detailed subject within an actual work setting. This means that actual practice is also brought into the training process, with real-life cases from the work situation being used as training material.

All Rescop Academy workshops are setup in the same way:

  • Introduction on the detailed subject
  • Execute your actual work while being guided by our trainer
  • Continuous feedback on the execution of the work

All our workshops are available to be delivered in-house and they can be tailored to suit the specific needs of your team. If needed the workshop can also be taught at an external location provided by Rescop.

What we offer

Rescop Academy delivers workshops in the following subjects:

Agile & Validation

Agile & Validation: Backlog Refinement

During this workshop the Agile/Scrum team will be guided in the execution of a Backlog Refinement meeting. The focus will be on the specifics of applying Agile/Scrum in a Pharma, Medical Device, or GxP environment. 
 
This workshop is ideally held during an actual Backlog Refinement meeting, the week before the upcoming sprint starts. 
 
Duration: 1-4 hours per workshop session, depending on the sprint length

Agile & Validation: Sprint Planning

During this workshop the team will be guided in the execution of a Sprint Planning meeting. The focus will be on the specifics of applying Agile/Scrum in a Pharma, Medical Device, or GxP environment. This workshop is ideally held during an actual Sprint Planning meeting at the beginning of a sprint. 
 
The session starts with an introduction of the theory and examples of assessing the workload of backlog items. This include the errors which are most regularly made while assessing the workload. The team will be guided during the actual Sprint Planning where our experienced Trainer and Scrum Master will help you bring the theory into practice. 
 
Duration: 1-4 hours per workshop session, depending on the sprint length 

Agile & Validation: Sprint Review

During the workshop the Agile/Scrum team, the Quality Representative, and Business Stakeholders will be guided in the execution of a Sprint Review meeting. The focus will be on the specifics of applying Agile/Scrum in a Pharma, Medical Device, or GxP environment. This workshop is ideally held during an actual Sprint Review meeting at the end of a sprint. 
 
After an introduction, the group will be guided during the actual Sprint Review where our experienced Trainer and Scrum Master will help you bring the theory into practice. 
 
Duration: 1-4 hours per workshop session, depending on the sprint length

Depending on the learning capabilities of the Agile/Scrum team, an Agile & Validation workshop can be repeated during one or multiple Agile events. Also, if it’s not the first sprint, the Sprint Planning workshop can be combined with a Backlog Refinement workshop at the same day. 

CSV & GAMP

CSV & GAMP: Project Management of Validation Projects

During the workshop project management of validation projects, you will be prepared how to manage validation projects. The impact of creation of validation deliverables on the project timelines will be discussed as well as specific risks one can encounter running a validation project. The System Development Life Cycle (SDLC) and relation to the validation project will also be discussed.

This workshop requires project management experience and experience in setup of a project schedule. This workshop is ideally held before a validation project starts.

Duration: ½ day

CSV & GAMP: Process Modeling

This workshop will guide you in the basics of process modeling needed for your System- or Process Validation or your QMS. The workshop is ideally held when at the beginning of a Validation project or when you are about to setup a QMS. 

We start with an introduction of the theory process modeling and BPMN (Business Process Modeling Notation). You will be guided in creating Process models following the BPMN method for your process(es). 

The second day focuses on discussing the created process models and improving the models according BPMN. An optional third day focuses on process improvement; identifying activities in the process that can be executed more lean. 
 
Duration: 2 times ½ day / 3 times ½ day 

CSV & GAMP: Risk Assessment

During the workshop Risk Assessment, the (validation) project team will be guided in the process of assessing risks. This workshop is ideally held at the beginning of a (validation) project. 
 
After an introduction of the theory, the team will be guided in preparation for a Risk Assessment meeting, with which the (validation) project team will continue to work outside the workshop. The second day focuses on the execution of the Risk Assessment meeting and the third day focuses on risk mitigation and reporting. 
 
Duration: 3 times ½ day / 3 times 1 day 

CSV & GAMP: Test Execution & Reporting

During the workshop test execution & reporting you will be prepared for test execution, how to review and how to report. This workshop is ideally held on the first day of test execution to be as effective as possible. 

The first session starts with an introduction of the theory and some examples of test executions. These examples include the errors which are most regularly made during test execution. 

After the introduction, you will be guided during the actual test execution of one of your systems. Our experienced trainer will help you bring the theory into practice. The second day is focusing on the review part and the last day on the reporting part. 

Duration: 3 times ½ day / 3 times 1 day 

CSV & GAMP: Writing Test Scripts

Rescop has developed a 6-step method for defining test cases and creating the actual test scripts. This workshop will guide you through this 6-step method using one of your own systems. Therefore, it is not only training, but will also lead to a usable deliverable. 

The ½ day starts with an introduction of the theory and some examples of Verification testing, and the introduction of the Rescop 6-step method for defining tests. After the theoretical introduction, a workshop approach is taken to define a real test case and script for an actual system. 

Duration: 3 times ½ day 

CSV &GAMP: Writing User Requirements

During this workshop the (validation) project team will be guided in the process of creating clear and unambiguous requirements and is ideally held at the beginning of a (validation) project. 
 
The session starts with an introduction of the theory of requirement writing and with the introduction of the Rescop 3-step method for defining requirements. The team will be guided in creating User Requirements following the learned 3-step method, with which the project team will continue to work outside the workshop. 
 
The second day focuses on discussing the created requirements since the last workshop and the third day focuses on completing the full set of requirements. 
 
Duration: 3 times ½ day / 3 times 1 day

Data Integrity

Data Integrity: Assessment of DI Compliance

During this workshop you will be guided in the assessment of a system for Data Integrity according a standard set of assessment documents and is ideally held when you need more insight on the DI Compliance status of applications. 
 
The first session starts with an introduction of the theory and examples of executed DI assessments. This includes examples of the most found data integrity gaps. After you will be guided during an actual assessment of one of your systems. You can continue executing assessments for other systems based on the theory. The second day is focusing on improvement possibilities found during the review of the executed assessments and the last day focuses on the mitigation of the identified gaps. 
 
Duration: 3 times 1 day

Data Integrity: Audit trail Review

During this workshop you will be guided in executing Audit Trail reviews for one of your systems. This workshop is ideally held when you need more insight on what to look for in Audit Trails and how to document any findings from the review.  
 
The first session starts with an introduction of the theory and examples of when audit trails need to be reviewed. After the introduction, you will be guided in an assessment on one of your systems to determine the need for Audit Trail review. 
 
The second day focuses on executing different types of Audit Trail review for your system(s) and the last day focuses on the reporting of executed Audit Trail reviews. 
 
Duration: 3 times ½ day

GxP

GxP: CAPA Management

During the workshop CAPA Management you will be guided in the process of managing your CAPAs in an effective way and is ideally held when you have a lot of CAPAs or when you experience recurring CAPAs. 
 
The session starts with an introduction of the theory of CAPA ManagementAfter the introduction, you will be guided in defining clear CAPAs and categorizing the CAPAs, based on risk. The second day focuses on determining mitigation measures to resolve the CAPAs and measuring the effectiveness of the implemented mitigation measures.  
 
Duration: 2 times ½ day 

GxP: Root Cause Analysis

During this workshop you will be guided in the process of determining the Root Cause of everyday problems and is ideally held when you experience recurring incidents, problems, or CAPAs 
 
The session starts with an introduction of the theory and with the introduction of a set of basic tools which can help you in identifying the Root Cause of any problem. After the introduction, you will be guided in executing a Root Cause Analysis for one of your problems, using the diverse tools. 
 
The second day focuses on determining mitigation measures to resolve root causes and measuring the effectiveness of the implemented mitigation measures.  
 
Duration: 2 times ½ day

Permanent Inspection Readiness

Permanent Inspection Readiness: Audit Preparation

During the workshop you will be guided in the process of preparing for an Audit
 
The session starts with an introduction of the setup of an Audit and the expected behavior, and an introduction to the preparation activities. After the introduction, you will be guided in preparing for an Audit by our experienced trainerwith which you will continue to work outside the workshop.  
 
The second day one of our Auditors will execute parts of an actual Audit for the prepared scope.  
 
Duration: 2 times 1 day