An intensive one-day training course on how to establish and improve compliance with the GMP requirements for process validation.

Both the FDA Quality System Regulation, 21 CFR Part 820, and ISO 13485 include requirements for process validation. In many cases manufacturers have not satisfactorily established compliance with the requirements in relation to process validation and have received adverse FDA inspections, including issuance of Warning Letters and Import Alerts.
The course is designed to ensure delegates fully understand the essential business and regulatory requirements for process validation.

Learning Objectives
The course provides an excellent opportunity to understand:

  • The regulatory requirements relating to process validation, and business benefits.
  • The key steps in performing adequate process validation, including preparation of validation protocols
  • How to perform process review and develop a validation master plan.
  • Delegates should on completion of the course be able to identify, plan and execute process validation activities in a structured and efficient manner, to satisfactorily meet both business and regulatory responsibilities.
  • Apply principles of the GHTF Guidance on process validation
  • How FDA examine process validation during inspections.

Course Format
The course presents the requirements for process validation comprehensively, and uses case studies, interactive sessions as well as formal presentations. Each delegate is provided with a course manual containing comprehensive notes on topics presented, and copies of relevant regulations and guidance documents are provided for the use of delegates during the course.

Delegates receive a "Certificate of Attendance".

Contact us for detailed training agenda and prices