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The Exhibit Hall, in Holiday Ballroom 4-6, opens today at noon with lunch.  Take full advantage of the exhibit time to build your industry contacts, discover new sources, and learn about the latest advances in equipment, supplies, and services....
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Welcome to the 3rd Annual ISPE-FDA CGMP Conference. The FDA and Industry experts will provide you with the insights you need to ensure quality both day-to-day and strategically, over the product lifecycle. No other event drives critical conversations...
iSpeak Blog
If you are going to the ISPE-FDA CGMP Conference, be sure to follow the events on Twitter with hashtag #ISPECGMP. If you are not attending, you can read the session recaps on ISPEAK, which is a great way to stay engaged at your leisure. Now, on to the...
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What makes the list of must eats in Baltimore? What else but Crabs, crabs, crabs! You haven’t eaten like a local unless you sit down, strap on a bib and get your hammer ready to crack open a dozen hot, steamed crabs, covered in old bay.  To blend in...
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Currently there are no standards or guidelines for system functionality that manage Investigational Medicinal Products (IMPs). Lack of standards for data and functionality has resulted in varying terminology, data formats, and controls, which can often...
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On 13 May 2014, ISPE Young Professionals in the Nordic Affiliate (headed by Honglu Yang from NNE Pharmaplan) held an ISPE Young Professional workshop at Novo Nordisk Headquarters in Bagsværd. Around 110 professionals from large pharmaceutical companies,...
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Many of us have adapted to new technology and found ways to make social media a part of our lives. Others have resisted and will only use it while they are kicking and screaming in protest. Let’s face it, social media is a permanent part of our lives...
iSpeak Blog
If you’re reading this post, you already know that ISPE is the go-to organization for pharmaceutical industry knowledge and information, and we thank you for adding our blog to your roster of trusted resources. As a dedicated professional in your...
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Whether you are looking for education on compliance strategies, quality, product development, manufacturing, or regulatory affairs, this conference was planned from an industry point of view. Next month’s conference was planned by Conference Chairs, Joe...
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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...
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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...
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"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...
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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...
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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,...
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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...
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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...