Compressed Air system Qualification and testing

Engineering and Validation

Operations

Quality

Target Level

• Validation and Qualification scientists, Supervisor and Manager
• Engineering Department Staff (Maintenance, Project Management, Utilities Engineers)
• Professionals from service organizations and vendors who serve pharmaceutical clients
• Quality Department (QA, QC, and Compliance)
• Regulatory bodies involved in pharmaceutical industries
• Internal/External Auditors and consultant

Description

Objectives and Expected Results

• Participants will take Idea about a different type of clean gases used in Pharmaceutical and healthcare industry
• Participants will take an idea of ISO 8573-Part1 (Contaminants and purity classes)
• Participants will take Idea about the best approach for conducting Successful Qualification for the Compressed Air System according to updated Risk-Based Approach (ASTM 2500 and ISPE CQ 2019)
• Participants will take Idea about the requirement of compressed air quality that must be considered to not compromise the environmental requirements of the classified spaces
• Participants will take Idea about the regulatory guidelines for the sake of successful inspection

Others Training Materials

Workshop, Sheets and case studies paper will be conducted and implemented during training

Target group