Read, Learn, Innovate: Top Blog Posts from June 2020
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from June 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
The User Requirements Specification document contains requirements from multidisciplinary sources and supports design, commissioning and qualification activities, operations, and maintenance. Brief highlights of answers to FAQs from prior workshops.
The guide describes Good Engineering Practice as a quality system, governed by SOPs that Quality approve; Quality approve the user requirements specifications, System Risk Assessment (SRA) and the Qualification acceptance and release report; Engineering, the suitably trained and experienced experts, are responsible for completing installation and operational verification. But note that the guide also allows the testing that will be used to support qualification to be extracted and put into a separate document that Quality pre-and post-approve as seen in Guide
ISPE’s first virtual conference, the 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference, is a new format for delivering education, information, and networking—a fitting first virtual meeting for ISPE given the cutting edge nature of the subject matter of biopharma, cell and gene therapies, and ATMPs. Like these technologies, ISPE and the conference attendees are adapting to new modalities—driven by the impacts of the COVID-19 pandemic—to embrace a new way of meeting and exchanging information.
We have all been given a lot of options lately. Google “things to do in quarantine” and you will have your pick from a slew of categories. With all these workout videos -- where to start? Which book to read? Make the trending Degong coffee or join my friends for an online Zumba class? Which conference platform is the best anyway, and why not try them all?
Making clinical trials more patient centric is among the many challenges facing the pharmaceutical industry. One method of improving the patient experience is by delivering study medication directly to patient homes, also known as Direct-to-Patient or DtP. However, the implementation of Direct-to-Patient may seem insurmountable in a highly regulated industry where specific regulations or guidance is lacking or vague. Additionally, Direct-to-Patient experiences can be inconsistent by country, trial, or therapeutic area.
ISPE’s Advancing Pharmaceutical Quality (APQ) team and the University of St.Gallen Operational Excellence (OPEX) team have partnered to develop a comprehensive program for assessing and improving an organization’s Quality Management Maturity. ISPE is...
Although travel continues to be reduced or restricted across the world, there is an upside: The 2020 ISPE Asia Pacific Pharmaceutical Manufacturing Virtual Conference & Executive Forum has now pivoted into a fully virtual conference and virtual executive...