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Aseptic Processing, Cleaning Validation, Environmental Monitoring
Novel Applications, Tools and Technology to Optimize GMP Processes
June 16 - 18, 2010
San Diego , CA
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Aseptic Processing is IVT’s 5th Annual conference and exhibition dedicated to professionals who need to understand the technical and regulatory fundamentals of aseptic processing operations in a pharmaceutical manufacturing setting. Aseptic Processing 2010 offers strategies and solutions to protect the quality/safety of products that ensure the highest contamination control standards.

Cleaning Validation, in its 7th year, continues to bring together analytical, engineering and validation experts to network and learn the most current, efficient and compliant cleaning processes being used by industry.  Whether you are new to the field or an experienced professional, this conference is a must attend for those with validation and quality responsibilities. 

Environmental Monitoring is IVT’s 5th annual event focused on risk management strategies to develop a lean, effective program.  Participants learn how to design an environmental monitoring process in an aseptic processing facility while focusing on continual improvement.

With workshops, interactive discussions, case studies, high-level moderators and real-life examples, ACE provides valuable take home knowledge and networking opportunities for the aseptic processing and sterile environment professional.  

  • ICH Q9 – Risk management strategies for aseptic processing and sterile products

  • Validation of aseptic processing and sterilization

  • Filtration efficacy

  • Sterilization of equipment, containers and closures

  • Calculating and setting residue limits

  • Developing a risk-based approach to cleaning validation

  • Cleaning validation for medical devices – Determine acceptance criteria and validation methodology for device classes

  • Application of Quality-by-Design to cleaning validation                                                                                                                                      

  • Methods for handling cleaning agents

  • Tools for ensuring environmental monitoring compliance

  • Rapid microbial technologies in environmental monitoring

  • Microbial identification and strain characterization

  • EM data and trends for CAPA                                     

  • EM approaches in water systems


Sponsors/Exhibitors:

  STERIS Corporation is a leading provider of infection prevention and surgical products and services, focused primarily on critical healthcare, pharmaceutical and research markets. The Company's approximately 5,000 dedicated employees around the world work together to supply a broad array of equipment, consumables and services solutions that enhance Customer productivity and quality and help make the world a safer place. The Company is listed on the New York Stock Exchange under the symbol STE. For more information, visit www.steris.com.

Hear what some of our previous attendees had to say:

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“Being new to cGMP manufacturing, this conference was detailed, yet gave me a broad range of information to the cGMP world.”
– Daniel Forest, Manufacturing Associate, Aeras

“Lightened my outlook on aseptic techniques.”
– Tina Miller, Manufacturing Associate, Aeras

“Good, broad overview of relevant topics in our industry today.”
– Brian Cogan, Production Manager, CBL

“Sterility is not easy, but is achievable and the Institute of Validation Technology shows you how.”
Diana Ortiz, Manufacturing Engineer, Abbott




For more information or to register, please contact the Institute of Validation Technology toll free by phone at 1.888.736.8547 or via e-mail at ivtreg@ivthome.com.

 
 
 
 
 
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