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Revision of EU GMPs Annex 1: What Impacts Can We Expect as an Industry? | 2020 saw the commenting of the draft Annex 1, which included many changes to the 2017 version. In this session, we will cover the commenting process both from the ISPE and the PHSS perspective. Selected topics will be discussed in detail. Based on the outcome of the session with regulators from the 2020 ISPE Annual Meeting, we will give an outlook on the implementation of the final guidance issued by EMA.
Opening Plenary Session | In this opening session, representatives from FDA and from industry will give their high-level perspective on where the Pharmaceutical Industry is heading…
Single Use Technologies - Are they sustainable? | Over more than two decades, the pharmaceutical industry has increasingly adopted single-use technologies primarily to simplify manufacturing and seemingly to reduce cost; however, the need to reduce environmental burden has a huge impact on these fa…
Devices and Decontamination—Overcoming Challenges | Aseptic products are oftentimes a component part of a Combination Product. These aseptically filled present technical challenges that will be addressed in this session. Additionally, manufacturers are often tasked with utilizing legacy equipment…