Featured in this edition of iSpeak Reading Roundup, are the top blog posts from July 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
There is sometimes a perception that computer systems validation requires a V-Model approach using a waterfall methodology. This means all requirements must be agreed before design can progress and in turn all design must be signed off before the system can be built, and so on until system release into operation.
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 forum providing attendees located anywhere in the world with real-time engagement with Regulatory and Industry leaders.
Our story started in October 2018 when I met a colleague at a conference and we had no time even to share our news: we were always in a hurry, only able to discuss business. The pharmaceutical industry is unique in its stability: many people who come here stay for a long time, and eventually colleagues become close friends. This is what happened to me: close professional engagement enabled me to develop relationships with amazing people, especially women.
Ensuring delivery of effective medicines requires an agile business strategy effectively utilizing technology to:
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.
In an increasingly complex world, where the reliable delivery of power from point A to point B often depends on substantial construction and upgrade activities, the need for efficient project delivery has never been more critical. For manufacturers, completing pharma facility and process optimization projects quickly and cost-effectively can be challenging. As a result, many are exploring new...
The 2024 ISPE International Honor Awards were presented at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida, in October. These awards provide the opportunity for the ISPE community to recognize and celebrate the dedicated professionals who volunteer countless hours to support ISPE and its mission.
This year’s 2024 ISPE Annual Meeting & Expo at Gaylord Palms in Orlando, Florida, USA was an inspiring experience, combining the energy of high-level industry discussions, networking opportunities, and moments of genuine connection. Despite the uncertainty brought on by Hurricane Milton, the conference went forward with an impressive spirit of resilience and adaptability. From insightful...