iSpeak Blog

Developments in Aseptic Technology: From Submissions to Approval to Sustainable Global Supply

Antonio C. Crincoli, PE
Developments in Aseptic Technology - ISPE Pharmaceutical Engineering

Aseptic processing of parenterals is one of the most challenging tasks within pharmaceutical manufacturing. Join us along with federal and state regulators at the 2019 ISPE South Asia Pharmaceutical Manufacturing Conference on 25 – 27 September, at the ITC Gardenia Hotel in Bengaluru, to discover the latest developments and regulatory expectations in aseptic manufacturing. The agenda is packed with content centered around the conference theme, The Quality Advantage – from Submission to Approval to Sustainable Global Supply. Here are some Aseptic sessions you can’t afford to miss and a few other top highlights of mine.

On Wednesday, 25 September, we will kick-off with an Executive Forum. Executives participating in the Executive Forum will hear from and enjoy in-depth discussions with pharmaceutical industry leaders on transitioning a new acquisition into a unified quality culture.

The 2019 ISPE South Asia Pharmaceutical Manufacturing Conference officially begins on Thursday, 26 September with federal and state regulators sharing recent trends in quality and compliance and case-studies by manufacturing companies. The entire conference emphasizes open dialogue to give you and your company an opportunity for actionable takeaways to take-back to your organization.

We will take a deep-dive into opportunities to modernize approaches in commissioning and validation using the latest technologies and risk-based methods available to the industry that remain rather under-utilized. A very timely topic following the recent release of the newly updated ISPE Baseline Guide Volume 5: Commissioning and Qualification.

On Friday, 27 September, we review Regulatory Expectations in Aseptic Processing: Review of Recent Findings, along with federal and state regulators sharing recent trends in quality and compliance and case-studies by manufacturing companies. There are a wide range of human and equipment factors to keeping the process sterile and compliant. In addition, we will dive into recent findings both globally and regionally and how they impact current manufacturing and quality assumptions.

With aseptic technology rapidly evolving with new process methods and innovations, Single-Use Technologies: Advantages and Disadvantages demonstrates how to remain cost effective and make the right decisions quickly. The use of disposable equipment and how it is finding its way into the whole production chain from de-bottlenecking operations to reducing contamination. You will get the opportunity to understand:

  • Risks and opportunities
  • How to integrate new technology
  • Ensure appropriate alignment of quality processes

You will also learn firsthand from industry leaders who understand these challenges and deal with them and have a unique opportunity to discuss the challenges you’re currently facing and gain some actionable ideas and solutions to improve your own processes.

On the final day of the conference, we are excited to host a Women in Pharma (WIP) breakfast. Women in Pharma® at ISPE provides women in the pharmaceutical industry a forum for connecting and collaborating on technical and career advancement topics

We wrap up with a Closing Regulatory and Industry Panel on Submission Do’s and Don’ts, featuring experts from the USFDA, MHRA, Roche-Genentech, Cipla, and AbbVie. Get your questions addressed and engage with these insightful pharmaceutical leaders.

Every session at 2019 ISPE South Asia Pharmaceutical Manufacturing Conference includes the opportunity to interact with federal and state regulators and industry leaders.

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