iSpeak

iSpeak Blog
You are sitting with a group of people around a table in a conference room. On the wall, a monitor displays a spreadsheet showing the inputs and outputs of a complex manufacturing process in a vast matrix. The purpose of the meeting is to assign risk...
iSpeak Blog
Followers of FDA warning letters and Form 483s will have noticed that over the last 12 – 18 months, there have been increasing mention of data integrity issues around manufacturing data, often as a result of outdated equipment and practices, such as: No...
iSpeak Blog
What is coming next in biopharmaceutical manufacturing? That question was addressed in plenary sessions at the 2019 ISPE Biopharmaceutical Manufacturing Conference 18-20 June in Boston on the second and third days of the conference. View more about the...
iSpeak Blog
As our industry continues to evolve with new and innovative technologies, new product launches, the approval of biosimilars and the continued pressures to drive cost down and quality up, the question remains how to design infrastructure, including both...
iSpeak Blog
The concept of the digital twin sounds like science fiction: a complete digital representation of your process or system, along with all the flexibility to play with simulations, creating feedback, and targeting optimizations. However, the foundation for...
iSpeak Blog
Featured in this edition of ISpeak iSpeak Reading Roundup are the top blog posts from June 2019. Explore critical- industry initiatives, membership Membership highlights, and more for what the pharmaceutical industry was reading last month. The...
iSpeak Blog
What is coming next in biopharmaceutical manufacturing? That question was addressed in plenary sessions at the 2019 ISPE Biopharmaceutical Manufacturing Conference 18-20 June in Boston on the second and third days of the conference. View more about the...
iSpeak Blog
Bart Van Acker Managing Partner Quality By Design NV You’ve been with ISPE for quite some time now. Can you please give me a little information on some...
iSpeak Blog
ISPE's professional pharma training allows for industry members to study challenges, develop solutions, and gain a better understanding of best practices and advancements in pharmaceutical science. The interactive discussions are led by subject matter...
iSpeak Blog
What is coming next in biopharmaceutical manufacturing? That question was addressed in plenary sessions at the 2019 ISPE Biopharmaceutical Manufacturing Conference 18-20 June in Boston on the second and third days of the conference. View more about the...
iSpeak Blog
Manufacturing biopharmaceuticals has many challenges requiring a clear understanding of every product’s goals and priorities. These challenges will only increase as more sophisticated products and therapies are developed.1 One of the recent advances in...
iSpeak Blog
Solano Community College Hosts Advisory Panel to Honor First Graduating Class On 22 April 2019, more than 40 professionals and students attended the ISPE- Solano Community Advisory Panel at Solano Community College. This event was held in honor of the...