Put yourself and your team on the path to success. Developed through research and industry demand, the IEST Education program allows novice-through-expert learners to achieve targeted knowledge to avoid training failures and thrive professionally. Many companies claim to provide expert training, but IEST's accredited expertise as an international standards developer assures confidence in the effectiveness of the training. You and your team will learn from the recognized experts who help write the technical standards used every day within your industry.

TRAINING SPECIAL - Attend all training courses by registering for the Education Passport and receive a discount.

Buy 3 Get 1 Free! Register 3 people from the same company for the same class and receive a 4th registration free. All four registrants must be from the same company to participate in this offer.

Program subject to change.
 

Monday, November 14, 2022
9:00 a.m. - 4:30 p.m. Central Time
Available in-person or virtual

Introduction to Cleanroom Microbiology
Instructor: Ziva Abraham

A Microbial Contamination Control program in any medical product manufacturing company needs to be based in knowledge and science in order to prevent product contamination and patient risk. Managing microbes in cleanrooms and subsequently in product starts with facility design and ends in product testing. This full day training will address the importance of understanding types of microbes present in cleanrooms, their ingress, transport and proliferation paths, cleaning and disinfection challenges, environmental monitoring strategies and testing requirements.
 

Tuesday, November 15, 2022
9:00 a.m. - 4:30 p.m. Central Time
Available in-person or virtual

GMP Cleanroom Qualification and Re-qualification Testing
Instructor: Morgan Polen

Cleanroom Qualification is the overall process of assessing the level of compliance of a classified cleanroom or barrier system (RABS, BSC, Isolator, Pass-box mobile HEPA cart) with its intended use. Different approaches are taken in different parts of the world as well as different testing methodologies. This course will highlight the different testing requirements as well as provide case-histories related to US FDA and International inspectors comments regarding cleanroom qualification testing as well as re-qualification. Attendees will gain a greater understanding of the required testing, and learn from mistakes others have made in the qualification testing of cleanrooms for GMP operations. Various FDA 483 observations and warning letters regarding qualification and testing will be covered. 
 

Wednesday, November 16, 2022
9:00 a.m. - 4:30 p.m. Central Time
Available in-person (full day) or virtual (full-day or half-day morning)

HEPA Filter Testing and Workshop

Morning Session (9:00 a.m. - 12:15 p.m.)

  • HEPA Filter Testing Real-World Problems (Morgan Polen, Microrite and Kyle Mulder, TSS)
  • Roundtable Discussion Panel - HEPA and ULPA Filter Testing and Problems
    • Kyle Mulder, TSS
    • Morgan Polen, Microrite
    • Hasim Solmaz, Lighthouse Worldwide Solutions
    • R. Vijayakumar, AERFIL

Afternoon Session (1 - 4:45 p.m.) note: virtual participants will observe hands-on workshop testing via live web-stream

  • Introduction to the Science of Filters and Particle Measurement (R. Vijayakumar, AERFIL)
  • Introduction to Testing Filters with Photometers and Particle Counters (Tim Triggs, ATI and Hasim Solmaz, Lighthouse Worldwide Solutions)
  • Hands-on Workshop Testing Filters with Photometers (Tim Triggs, ATI) - note: virtual participants will observe testing via live web-stream
  • Hands-on Workshop Testing Filters with Particle Counters (Hasim Solmaz, Lighthouse Worldwide Solutions) - note: virtual participants will observe testing via live web-stream
  • Wrap-up Q/A Roundtable Discussion

 

Thursday, November 17, 2022
9:00 a.m. - 4:30 p.m. Central Time
Available in-person or virtual

Aseptic and Sterile Processing Fundamentals
Instructor: Paul Andrea

Aseptic or sterile manufacturing is one of the most important parts of biopharmaceutical manufacturing. Due to the nature of the biopharmaceutical industry, sterility and contamination control are of the utmost importance in the manufacturing process. Many factors such as facility design, cleanroom design, equipment integration, ergonomics, operator training, and behavior must be considered when building and operating an aseptic processing facility.