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Aseptic Processing Training Course

: 28 Jan 2019 - 1 Mar 2019

: Bethesda, United States

Sector: Pharmaceutical

Type: Training


This 2 week course takes place as follows:

 

Week 1 (Jan 28 to Feb 1, 2019) will include..

 

  • Definition and scope of aseptic processing
  • Facility design
  • Velocity and airflow studies
  • Basic microbiology
  • Filtration and liquid filter integrity testing
  • Aseptic process simulations (media fills)
  • Environmental monitoring and control systems
  • Sanitization techniques and sterilization qualification
  • Gowning, personnel and aseptic technique qualification
  • Lyophilization
  • EU/US Regulations

 

Week 2 (Feb 25 to Mar 1, 2019) will include...

 

  • Reading and evaluating media fills
  • Good documentation practices
  • New process and facility technology
  • Environmental data trending and excursion analysis
  • Moist heat sterilization
  • Rapid microbial identifications
  • Industry hot topics
  • Isolators/Bio-decontamination
  • Endotoxins and LAL testing
  • Sterility Testing
  • Liquid Particle Testing

 

This course is intended for professionals who are involved in sterile manufacturing. Typical areas and roles include the following:

 

  • Manufacturing - Director/Manager/Supervisor/Operator/Technician
  • Quality Assurance - Director/Manager/Supervisor/Specialist
  • Quality Control - Director/Manager/Supervisor/Analyst
  • Engineering - Manager/Supervisor/Technician/Engineer
Venue

Bethesda
United States


Organizer

PDA USA
Phone: +1 (301) 656-5900
Email: registration@pda.org
Visit: http://www.pda.org/


<< Previous article
SMi's 8th Annual...
Next article > >
Controlling Listeria...