Key Workshop Subjects Offered by Rescop Academy

• Agile & Validation: Backlog Refinement
  This workshop guides your Agile/Scrum team in a Backlog Refinement meeting, with a focus on applying Agile methodologies in Pharma, Medical Device, or GxP environments. Ideally scheduled a week before an upcoming sprint.

  • Duration: 1-4 hours per session

• Agile & Validation: Sprint Planning
  This workshop assists the team during a Sprint Planning meeting, focusing on workload assessment and Agile/Scrum principles in a GxP environment. It includes theory, practical examples, and guidance on sprint execution.

  • Duration: 1-4 hours per session

• Agile & Validation: Sprint Review
  Tailored for the Agile/Scrum team, Quality Representatives, and Business Stakeholders, this workshop enhances your Sprint Review process in a Pharma, Medical Device, or GxP setting.

  • Duration: 1-4 hours per session

• CSV & GAMP: Project Management of Validation Projects
  Learn how to manage validation projects effectively. Topics include validation deliverables, timelines, risks, and the System Development Life Cycle (SDLC).

  • Duration: ½ day

• CSV & GAMP: Process Modeling
  Master process modeling for your System Validation, Process Validation, or Quality Management System (QMS), starting with Business Process Modeling Notation (BPMN) and practical application.

  • Duration: 2-3 half-day sessions

• CSV & GAMP: Risk Assessment
  Guided risk assessments for validation projects to identify and mitigate risks. Sessions cover theory, practical assessment, and mitigation strategies.

  • Duration: 3 half-day/full-day sessions

• CSV & GAMP: Test Execution & Reporting
  A practical workshop for test execution and reporting within a validation project. Emphasizes common errors and best practices, including hands-on test execution.

  • Duration: 3 half-day/full-day sessions

• CSV & GAMP: Writing Test Scripts
  Develop test cases and scripts using Rescop's 6-step method, using one of your own systems to create a usable deliverable.

  • Duration: 3 half-day/full-day sessions

• CSV & GAMP: Writing User Requirements
  Create clear and concise User Requirements for a validation project using the Rescop 3-step method.

  • Duration: 3 half-day/full-day sessions

• Data Integrity: Assessment of DI Compliance
  Conduct comprehensive Audit Trail reviews for your systems and document findings. Gain insight into Data Integrity (DI) compliance.

  • Duration: 3 half-day sessions

• GxP: CAPA Management
  Learn to conduct Corrective and Preventive Action (CAPA) assessments to manage and improve Data Integrity.

  • Duration: 3 full-day sessions

• GxP: Root Cause Analysis
  Identify the root cause of recurring problems and determine mitigation measures using various tools.

  • Duration: 2 half-day sessions

• Permanent Inspection Readiness: Audit Preparation
  Prepare for audits by understanding audit setup, expected behavior, and preparation activities. Includes a real audit simulation.

  • Duration: 2 full-day sessions

Rescop Academy provides industry-leading workshops that combine practical skills and regulatory compliance knowledge, enhancing your team's expertise in validation, GxP compliance, Agile methodologies, and more.