Environmental Monitoring for Pharmaceutical Facilities (ISO 14644 Compliance)

Engineering and Validation
Operations
Quality

Duration
3 days (2 days can be customized)
Course fee
-

Program Description

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

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

  • -

    Trainer Languages English/Arabic

Sign up

Interested in signing up a group of people for this course?

Please contact our Business Development team:
info@pharmatrixco.com
00962 798756232