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ISPE San Francisco Member Reflects on His Career and How it Affects His Personal Life Source: ISPE San Francisco Chapter Volume 19.2, 2014 About a week before Christmas last year, I was playing with my kids in a school yard, where I fell and scraped...

ISPE Updates Guide to include Key Concepts of a Global Implementation Pharmaceutical water and clean (pure) steam are used as utilities and ingredients for Good ManufacturingPractice (GMP) processes, which produce drug products and drug substances...

"Pharma needs to ensure it pays attention to how patients feel about the way they are taking their medication. By listening to patients, pharma can help simplify adherence for the patient." This is just one of the messages Christine Milligan, as Team...

Knowledge of product development through manufacturing discontinuation has never been more significant in mitigating industry challenges. Learn to address the impact of risk-based approaches and supplier dependability to ensure your company’s...

In our previous blog we talked about the key components of a master plan. In this chapter we want to discuss how a master plan can help alleviate the issues associated with legacy facilities such as compromised flows, dangers of cross contamination,...

Over the past few years, CMO partnerships have grown by approximately 11% annually and are projected to continue increasing at a steady pace. According to Global Industry Analysts, Inc. (GIA) the global market for pharmaceutical contract manufacturing...

An investment in knowledge pays the best interest -- Benjamin Franklin

In our previous blog post, we concluded that although legacy pharmaceutical manufacturing facilities present many challenges, they are worth rehabilitating. In this discussion, we explain the components of a master plan. In our next blog post, we talk...

Following ISPE’s 2013 Drug Shortages Survey and the Society’s commitment to seek best-practice solutions to the problems identified, ISPE today announces a line-up of activities that will bring pharmaceutical industry stakeholders together at its first...

ISPE’s North and South American Affiliate Council (NASAAC) met with Board Members and Staff in Tampa, Florida, on 24-25 March 2014, to collaborate on strategies to strengthen ISPE and help enhance the success of ISPE’s Affiliates and Chapters in the...

Now more than ever, pharmaceutical professionals are being asked to do more in shorter time periods within tighter financial confinements. In addition, regulations for the industry continue to increase and change rapidly. To meet this every demanding...

With increasing complexity of supply chains and the need to rapidly respond to internal and external demands, we must remain committed to using sound science and risk based approaches to ensure control. The 3rd Annual ISPE-FDA CGMP Conference is the...

The 2014 Facility of the Year Awards program is shaping up to be one of the most noteworthy events of the year. A few weeks ago, we talked about what the pharmaceutical and biopharmaceutical industry can learn from the facilities recognized by FOYA....

Pharma EXPO is an exciting new event making its debut this November in Chicago. Brought to you by ISPE and PMMI, Pharma EXPO will bring together thousands of pharmaceutical, biopharmaceutical, medical device, personal care and nutraceutical manufacturers...

Around the world, countless patients with a high degree of unmet medical needs are in urgent need of new therapeutic alternatives. For many of these patients, access to new innovative medicines via the well-defined clinical trial process or through...

As a planning team member of the Statistician Forum, I am extremely excited to see that the conference discussion topics are attracting so many statisticians from around the world. Since the issuance of the FDA Guidance on Process Validation in January...

The pharmaceutical industry is facing a restructuring in quality management.  The manufacturing goal of producing consistent, high-quality products with minimal regulatory oversight is revealing a new path. The FDA and CDER are in the process of...

The submissions are in. The judges are preparing to meet.  That can only mean one thing: the 2014 Facility of the Year Awards (FOYA) Category Winners will soon be announced, kicking off our year-long celebration of industry’s dedication to excellence in...