We made it to Madrid for CPhI Worldwide on Sunday, less a couple of posters. We are kicking off the pharmaceutical industry’s largest trade show with two free educational seminars on Tuesday, October 13. Take a look:
Session 1: TPA-IT®, Trans-Pacific Aseptic Institute of Training, Tuesday, 1:00-1:25 pm, Hall 1, Stand 1D50.
This session is presented by Scott Wheelwright, PhD, Complya Asia
Aseptic fill-and-finish is the most demanding of pharmaceutical manufacturing processes. To ensure an exceptionally trained manufacturing workforce in China, PaizaBio is introducing TPA-IT, the Trans-Pacific Aseptic Institute of Training at this information-packed session at CPhI. The goal is to provide the highest quality training anywhere in the world to ensure students possess the knowledge and confidence required in the demanding environment of aseptic processing for the manufacture of sterile pharmaceutical products.
TPA-IT is located on the campus of Ausia BioTech in Hangzhou, China. The $8 million dollar sterile university is open to employees of Ausia BioTech, other pharmaceutical companies, contract manufacturing organizations, and government and regulatory entities from around the world.
TPA-IT training includes structured lecture and hands-on learning experiences in the principles of sterile manufacturing, quality management and regulatory compliance. Core Areas of Training include:
- Theory and principles of aseptic processing
- Pharmaceutical engineering
- Sterile manufacturing
- Quality management
- Regulatory compliance
Facilities that include qualified clean rooms with fully functional HVAC systems and commercial grade equipment, and a lecture hall that accommodates 50 students. The experience is designed to accelerate learning and maximize students’ retention of information and skills.
Session 2: BAO-Gong®, Bioanalytical Operations Global Observation Navigation Guide System, Tuesday, 1:30-1:55 pm, Hall 1, Stand 1D50.
This session is presented by PaizaBio founder Stuart Rose, PhD, and Hidehiro Akashi, PhD, Hitachi Consulting.
So what is BAO-Gong? It is a way for PaizaBio’s client around the world to put a virtual “person in the plant” in our plant in Hangzhou, China, to monitor production of their aseptic drugs from start to finish using the industry’s most comprehensive real-time, remote manufacturing system. BAO-Gong includes two primary components:
- Hitachi’s HITPHAMS® manufacturing execution software system for pharmaceutical manufacturing, which captures and reports on multiple technical and environmental metrics.
- Integrated live stream CCTV (closed circuit television system) in all PaizaBio/Ausia BioTech manufacturing suites.
These features give PaizaBio clients a virtual person in the plant who has strict control in reviewing, in real-time, the aseptic fill-and-finish of their drugs into final dosage forms and packaging via their laptop, PDA, or smart phone anywhere in the world.