Read, Learn, Innovate: Top Blog Posts from January 2020
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from January 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
Aseptic filling of parenterals is one the most challenging tasks within pharmaceutical manufacturing. There is a wide range of topics that fall under this umbrella, from more engineer-driven topics like filling accuracy and machine performance to key production questions, like how to keep the process sterile and compliant with the law and the regulatory guidelines. All this is influenced by new methods and technology innovations, either process- or technology-based.
ICH Q12 is another quasi-management-based regulatory guideline.1 In a nutshell, the industry should expect additional confusion and more work from a vaguely defined, potentially duplicative system that will likely further inhibit the industry from achieving excellence. In order to achieve excellence, the lifecycle product management concepts described in ICH Q12’s title need to be a lot more than retrospective change control.
I have been going to the ISPE Aseptic Conference since 2008 and the overwhelming response is that this is the best technical conference that ISPE hosts. The amount of learning, networking, and understanding that you can get at this conference is unparalleled. There are some valuable lessons that can be had at the Aseptic Show.
Biopharmaceutical manufacturing faces many new opportunities as we enter this decade. ISPE is returning to Boston for the 2020 ISPE Biopharmaceutical Manufacturing Conference on 1-3 June 2020, bringing you once again an innovative conference, followed by the 2020 ISPE Continuous Manufacturing Workshop and relevant training classes 4-5 June 2020.
The GAMP® Global Leadership strongly supports a patient-centric and quality risk-based approach to the assurance of computerized systems. Explore the incorporation of innovative computerized technologies and approaches that advance pharmaceutical production to support product quality, patient safety, and data integrity.
If you work in the parenteral manufacturing space, it’s a foregone conclusion that you can pinpoint the emotion and anxiety that comes from receiving word that the FDA has arrived at your facility for an inspection. If Billy Joel were to pen the lyrics...
The theme of “Proactive Career Design” for the Women in Pharma® (WIP) Breakfast Session at the 2020 ISPE Facilities of the Future conference on 31 January in San Francisco was a fitting one: design and implementation apply equally well to careers as to...
“I’ve never received such useful advice about my career before. I came to the event last year but I still learned so many new ideas and tips this year,” says Megha Shah, a Chemical Engineering Student from UMass Amherst. Megha was one of the many...