Call for Volunteers - ISPE Good Practice Guide: Maintenance 2nd Edition
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:
Environment, health, and safety in a maintenance environment
Maintenance templates and examples
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.
Members of the paperless validation subcommittee created this blog post to discuss and recommend “true copy verification practices” for the use of Paperless validation systems to satisfy the current guidance for data integrity, and to discuss how to fully eliminate paper from various validation processes without impacting compliance to these current regulations.
The Biopharmaceutical industry continues to grow and deliver life-changing medicines to patients as evidenced by the number of drug approvals by the FDA year after year. In 2022 alone CDER approved 37 novel drugs, either as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biological products under Biologics License Applications (BLAs). This has all been...