Guides & tools

Validate any software and make sure it meets all your usage and regulatory requirements.

Manage all tasks related to equipment: qualification, verification, calibration, and overall maintenance.

Build your own skills matrix to define the required skills for a specific project or team.

Plan and manage your company training without skipping any important subject in the process.

Provide step-by-step instructions on how to perform tasks at your company.

Outline specific assignments and steps of broader processes and procedures.

Analyze and understand the cause of a problem using the 5 Whys technique.

Find the root cause of a problem and identify possible solutions by reviewing underlying issues.

Define the quality management system of your organization and how it should function.

Discover the main changes and updates you need to take into account regarding the manufacture of sterile medicinal products.

Learn the eight steps of how to successfully respond to an FDA warning letter.

Get a complete overview of what has changed in this second edition by ISPE.

Nail a non-conformance report, avoid recalls, and legal penalties, and, improve your product quality!

Perform an internal audit correctly and foster an organization-wide quality culture.

Start preparing all your documentation to launch your pharmaceutical product fully compliant on the market.

Learn the usage of both methodologies and how to get certified.

Achieve your goals and drive positive change in your organization.

Use the 8D approach to plan and build a compliant and efficient Corrective and Preventative Actions (CAPAs) report.

Do a free assessment of your QMS readiness under EU MDR and ISO 13485:2016.

Get insightful tips on how to improve your organization’s processes and quality culture, and identify areas for improvement.

Understand the basics of Smart Quality methodology and execute it in your organization.