Our Training Partnership with The QARP

Enhancing Clinical Compliance and Quality through Expert-Led Training Modules

We are excited to announce a partnership with The QARP (Quality Assurance Research Professionals) to create specialized training materials aimed at advancing quality assurance in the life sciences sector. Together, we will equip those new to the industry with the foundational knowledge and skills needed to navigate regulatory requirements and ensure compliance in computerized systems validation (CSV).

The QARP is a global network of independent auditors, QA consultants, and trainers dedicated to excellence in clinical trials. They provide expert auditing, consulting, and training services, including GCP, GCLP, GDP, GLP, and CSV. Their specialized teams ensure regulatory compliance and operational integrity through tailored quality management solutions.

Our First Course: Computerized Systems Validation (CSV)

As part of the expanding training arm at Achieve Intelligence, our first course in partnership with The QARP will focus on Computerized Systems Validation (CSV). Designed for those in life sciences but new to CSV, this course covers essential aspects of regulatory compliance, data integrity, and risk assessment.

Our team is contributing key modules that build foundational knowledge and offer practical guidance on achieving compliance and maintaining system integrity—drawing from their extensive, hands-on experience with computerized systems in the industry.

Register for the course here

Course Structure

This course is for those in life sciences but new to CSV and is structured as follows:

  • 3 Live Expert-Led Sessions: Engage in interactive, online sessions led by seasoned industry experts.
  • 6 Hours of Learning: Participate in 6 hours of structured learning, with opportunities for self-paced review to reinforce key concepts.
  • Focus on Global Standards: Dive deep into the essentials of GAMP® 5, GMP Annex 11, and CFR Title 21 Part 11.

Course Topics

Understand the fundamentals of computerized systems validation, from methodology to compliance best practices
 
Compliance and Regulatory Standards
Learn how to navigate complex regulatory environments and ensure your systems meet GAMP® 5, Annex 11, and CFR Title 21 Part 11 standards

Gain insight into effective vendor selection and audit processes to ensure systems meet both regulatory and operational expectations

Explore why implementing computerized systems is not just a task but a full project. Here will dive deep into project management strategies, explaining when to use Waterfall vs Agile approaches, and how to decide based on the product’s maturity

Key stages of CSV include developing URS, FS, TS and understanding how these documents support the system lifecycle and compliance efforts

Learn how to manage risks throughout the system's lifecycle, including vendor audits and ongoing system support, to maintain system performance and compliance
Real-world insights from industry experts on common challenges and best practices during the validation process