The ISPE 2016 Process Validation Statistics Conference is in its 3rd year, continuing with its successful tradition of bringing together pharmaceutical leaders within the industry and regulatory authorities to share their thoughts in the implementation of the lifecycle approach to process validation. The keynote talks are always inspiring – and this year is no exception:
The ISPE 2016 Process Validation Statistics Conference will feature:
As always, there will be a mixed group of statisticians and process validation practitioners, representing every category of pharmaceutical manufacturing (small molecule, large molecule, devices, and more). For those of you who are not statisticians but want to know more about the statistics used in process validation and be better prepared for the conference sessions? There will be two 90-minute session on the first day of the conference to make you become better acquainted with some of the key topics that will be discussed during the sessions:
Learn more and register for the ISPE 2016 Process Validation Statistics Conference to be held on 25 – 27 October in Bethesda, MD USA, and bring your colleagues with you!
In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical component that ensures the sterility of products. Regulators have a set of comprehensive requirements that minimize the risk of contamination. Regulators set the requirements; however, the industry has an obligation to the patients who rely on and expect a drug that is safe and free of contamination....
Like any investment in digital manufacturing systems, demonstrating business payback before and after investment is critical to getting MES projects approved and verifying profitability after investment. Whether it is introducing MES, expanding it to additional sites, switching software, upgrading existing software, or developing electronic production records (EPR) for new drug products,...
Sustainability is emerging as a pivotal force influencing the pharmaceutical industry’s dynamics and steering companies towards transformative change. The focus of this analysis is to delve into the sustainability key performance indicators (KPIs) of prominent pharmaceutical players, namely Pfizer, Sanofi, Glaxo Smith Kline (GSK), Becton Dickinson, Johnson & Johnson, Abbott, Eli Lilly, and...