Overview

In today’s highly regulated life sciences industries, failing to properly validate processes or software can lead to costly recalls, regulatory scrutiny, and compromised product quality. Whether it’s a new medical device, pharmaceutical process, or automated system, organizations need robust validation programs to ensure safety, effectiveness, and compliance. The Software and Process Validation Training equips professionals with the practical knowledge and skills required to meet these critical requirements.

This three-day live online course provides a comprehensive understanding of process and software validation across the Pharmaceutical, Medical Device, Biotech, Biopharmaceutical, and Cosmetic industries. You will learn how to design, plan, and execute validation programs that align with regulatory expectations from the FDA, ISO 13485, ISO 14971, and GHTF guidance. Through expert instruction, real-world case studies, and interactive exercises, participants will gain hands-on experience developing validation protocols, implementing IQ, OQ, and PQ, and maintaining validated systems over time.

The course also covers software validation, including FDA guidance, the classic V Model, software requirements development, verification and validation testing, defect prevention, and validation of automated and COTS systems. Participants will complete exercises such as validation master planning, protocol development, process capability assessments, and software testing scenarios to reinforce learning.

This class is certified by Exemplar Global, and participants who complete all sessions and exercises will receive a registered certificate recognized worldwide. With this training, you will gain the confidence and practical expertise to lead or support a compliant validation program, ensuring your processes and software consistently deliver safe, effective, and regulatory-compliant results.

Topics Covered

• Process validation principles and regulatory requirements

• Validation protocols: IQ, OQ, PQ

• Master Validation Plan and planning elements

• Statistical methods and process capability

• Managing deviations and maintaining validation

• Software validation principles and lifecycle

• FDA guidance, V Model, and defect prevention

• IQ, OQ, PQ testing for software

• Validation of automated and COTS systems

• Documentation, traceability, and post-change validation

• Protocol development and case studies

• Installation, operational, and performance qualification exercises

• Software testing exercises and traceability matrix

Who Should Attend

• Those responsible for planning and operating a compliant process and software validation program
• Process Engineers
• Operations Personnel
• Quality Personnel
• Regulatory Personnel
• R&D
• Design Engineers
• Product Formulators

This Process & Software Validation training course is certified by Exemplar Global, and upon completion, participants will receive a certificate that says they have successfully completed a course certified by Exemplar Global.