The 2nd edition of the ISPE Good Practice Guide: Maintenance is currently under revision and the team leaders, Constantino Rodriguez (formerly Outlook Therapeutics) and George Wittman (JLL Chicago), are looking for additional volunteers to assist with specific chapters for the update. They are looking for subject matter experts to draft and/or edit content for the following topics as they relate to maintenance:
As part of the authoring team, you would work closely with the team leaders to create technical content for a chapter/section of the document. You may also be involved with the review of other portions of the document. Team members are expected to work collaboratively with other authors while producing content. You must agree to be accountable for your aspect of the work by ensuring that comments are adequately resolved during the multiple review processes (including industry review).
If you are interested in participating in this Guide, please email your contact details, a brief description of your experience, and the specific topic(s) you would like to work on. Upon acceptance to the authoring team, you will be required to sign the ISPE Contributing Author Agreement form.
As with all aspects of our life sciences industry, understanding how we can best meet the needs of patients with the timely delivery of life saving and sustaining products is of paramount concern. During the years since the global pandemic, the expectations and pressures on the pharmaceutical industry with respect to development, speed to market, quality and sustainability have increased...
At the 2024 ISPE Europe Annual Conference, held in Lisbon, Portugal, 16-18 April, Richard L. Friedman, MS, Deputy Director of the US Food and Drug Administration’s (US FDA) Office of Manufacturing Quality, in...
Insight from Austria’s Regulatory Authority Representative
At the 2024 ISPE Aseptic Conference, held March 12-13 in Vienna, Austria, Christina Meissner, a European Union Good Manufacturing Practice (GMP) inspector at the Austrian Agency for Health and Food Safety since 2013, and Chair of the PIC/S Drafting Group on Annex 2A and 2B, published in May 2021, offered a presentation titled...