Read, Learn, Innovate: Top Blog Posts from January 2021
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from January 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
Member Spotlight – Lou Kennedy
Lou Kennedy, Nephron Pharmaceuticals’ President & CEO and active ISPE Member, was recently honored with a 2020 Business Leader and Public Servant of the Year Award. We spoke with Lou to learn more about her company, the many initiatives she and Nephron are undertaking on behalf of pharma, Nephron’s community, and how women are making a difference in the industry.
Ready to Change the Way You Think About Engineering, Construction, & Operation?
The 2021 ISPE Aseptic Conference is your key to unlocking success – success in personal technical growth, success in a robust project execution, and success for continuous operation and improvement. I have said for years that the ISPE Aseptic Conference is the best technical conference and has taught me more than any other event.
Conceptualizing a Streamlined Performance Assessment – The St.Gallen APQ Benchmarking Tool
The ISPE APQ Assess, Aspire, Act and Advance Framework will be complemented with an OPEX Benchmarking and ICH Q10 maturity assessment tool specifically developed for use with the APQ program by the University of St.Gallen, Switzerland. Used in conjunction with the APQ self-assessment tools for quality management maturity, the pre-and post- benchmarking activities offer objective evidence of performance improvement to support ongoing investment of time and resources along the APQ framework.
What Is Next in Manufacturing Injectable Sterile Products?
As we enter the new year, this is the perfect time to make the 2021 ISPE Aseptic Conference part of your personal professional development plans. The virtual conference will allow participation from across the globe with no risk to pandemic exposure. The three-day format with shorter sessions will minimize impact to workdays and will allow attendees to participate in the sessions that will be most impactful to their personal interests.
It’s a New Year - Make Accountability a Resolution!
What is accountability? By definition, “it is taking or being assigned responsibilities for something that you have done or something that you are supposed to do.” We can take this far beyond that. Accountability means doing what we say we will do, always, on time and to the best of our ability. It means setting goals and achieving them. It means consideration of others, saying yes to things we know we aspire to do and are capable of doing, and being able to say no when we are not confident that we can complete something successfully.
