Process validation can be classified as the validation of controlled interaction of components, equipment, environment, software and personnel to produce a product or achieve an acceptable outcome. Process validation is one of the most critical elements in the pharmaceutical industry today. The concept of process validation recognizes that quality cannot be tested into the product and must be designed into the process/product to reduce the risk of non-conformances during/after manufacturing.

This two-day comprehensive training workshop covers all aspects of process validation and is presented as a combination of lectures and workshop sessions. The course reviews the latest FDA’s new draft guidance and other regulatory requirements, including: ISO, E.U., Japan and ICH Q8, Q9, Q10.

This course provides practical guidance on compliance with the requirements of process validation that lead to risk-based, reasonable and supportable informed decisions. Compliance with the requirement for process validation must go hand in hand with sound science for the proper evolution of critical processes.

Attendees will gain a strong grasp of total process validation - from initiation through maintenance and Change Control, from both theoretical and practical aspects including major concepts and terminology of process validation, and major qualification stages of process validation and “what” and “how” to validate, with emphasis on written documentation and standard operating procedures.

By the end of this 2-day course and interactive workshop Sessions the following topics will be covered:

Purpose, Benefits and Objectives of Process Validation
FDA’s November 2008 New Draft Guidance on Process Validation Global Regulatory Requirements for Process Validation
ICH Q8, Q9 and Q10, and ISO requirements for Process Validation
Validation as Part of the Quality Management System
Process Validation Life-Cycle
Planning and Resource Requirements
Differentiating between equipment, process, and product
Compliance Requirements for IQ, OQ, PQ
Process Monitoring, Control and Documentation
Validation techniques: Process Characterization and Process Flowcharts
Ensuring Completion of Pre-Validation Activities
Revalidation and Post-Validation Activities
Failure Mode and Effects Analysis (FMEA)
Integrating Quality Risk Management to Process Validation
Developing & Implementing Validation Protocols
Establishing records documentation requirements
Preparing a Validation Summary Report
Designing and Utilizing the PV Master Plan
Preparing a Validation Assessment Checklist

CAD $675.00 + GST