Environmental Monitoring for Pharmaceutical Facilities (ISO 14644 Compliance)

Engineering and Validation

Operations

Quality

Target Level

• Validation and Qualification scientists, Supervisor and Manager
• Quality Senior Management
• Production supervisors or Manager
• Quality Department (QA), QC (Micro), Regulatory Affairs and Compliance
• Professionals from service organizations, contractors, designers, and vendors who provide services for pharmaceutical Industries/clients.
• Regulatory bodies involved in pharmaceutical industries.
• Internal/External Auditors and consultants.

Description

Objectives and Expected Results

Topics to be covered with this training includes:

• Part1: Fundamentals for HVAC system
• Part2: Development of Performance Qualification for HVAC system include:
• PQ perquisites and training requirements
• The individual component test includes the followings:
• Air Flow Measurement
• HEPA Filter Integrity Test
• Air Volumetric flow test
• System Component Integration Test:
• Room Air Change Test
• Room Deferential Pressure Test
• Temperature Mapping Studies
• Humidity Mapping Studies
• Environmental Test:
• Air Flow pattern
• Particle contamination (Classification)
• Recovery Test
• Brief for Microbial Contamination Tests
• Part3: Environmental Monitoring Programs and Regulatory requirements:
• EM Prerequisites and Requalification Program
• Environmental Monitoring Trending and Statistical approaches

Others Training Materials

• Workshop, Sheets and case studies paper will be conducted and implemented during training
• Documentary Videos will be presented for OSD Equipment and systems, including Mixing, Blending, Drying, Sizing, Tableting, Encapsulating, and Coating that provides participants with a visual demonstration of current manufacturing and engineering practices.

Target group