Make the Most of Your Membership!
Welcome to your free monthly gift from ISPE! Don't let a single ISPE membership benefit go to waste - enjoy these knowledge, community, and professional resources, available only to ISPE Members!
Questions about quality and risk management dominated the recent ISPE/FDA CGMP Conference. Now's your chance to learn more about the fundamentals of risk management and quality management systems with this month's free webinar.
The Quality Systems: Risk management and quality management systems webinar, part of the CPIP online learning series, reviews the purpose, elements, and implementation of quality management systems, and risk management strategies. Highlights include a review of change control, CAPA, and internal assessment programs.
Learn more about:
Don't miss your chance to receive this information, normally valued at $149, for free—view the webinar now!
Offer is available to Members through 31 July 2012.
Companies are trying to better understand the cost/benefit equation for investing in Quality by Design (QbD) as the importance of product and process understanding is being highlighted by global regulatory authorities. During the recent ISPE/FDA Conference in Baltimore, Maryland, it was revealed that approximately 60 QbD submissions have been received by the FDA since the first QbD submission in 2006. The adoption of QbD is a timely industry issue that was at the forefront during the sessions in Baltimore and a topic that the ISPE PAT Community of Practice (COP) felt needed more clarification.
With that objective in mind, the PAT COP set out to answer some thought provoking questions in a recent survey on the business benefits of QbD, resulting in global companies of varying sizes providing their candid, independent opinions on the following:
The article provides information that balances business and regulatory drivers in relation to QbD. Even though some regulatory bodies have provided guidances for QbD, the industry has been unsure of how to interpret these guidances to assess what business investments or change in practices are required to apply QbD. The survey results attempt to clarify this important area so that companies can make informed decisions about adopting QbD.
Learn the business benefits of QbD—download ( 352 KB) your copy of the article today!
Process Analytical Technology activities are related to obtaining process understanding and the development and implementation of real time monitoring and control strategies for manufacturing processes. ISPE’s Process Analytical Technology Community of Practice (PAT COP) is a global community that provides a common industry thread by linking the relevant people, content, and resources of Affiliates, Chapters, academia, and other special interest groups.The local Ireland/UK PAT COP conducted the survey that was based on the article titled “The Business of QbD: Results of an International Survey."
The PAT COP provides both informal and formal technical meetings and networking opportunities on a local and global basis. Recent projects include the development of the "Implementing Knowledge Management in Bioprocesses ( 1 MB) " Concept Paper; and the delivery of a new training course being offered during ISPE’s Annual Meeting titled “Turning QbD into Practical Reality.”
Visit the PAT COP website to participate in technical discussions and learn more about the PAT COP.
Volunteers are vital to the success of ISPE. Partnering with staff, Volunteers help to implement the global mission and programs of the Society. You can take part in helping drive innovation in pharmaceutical manufacturing by volunteering your time for ISPE programs, activities, and committees.
What Are the Benefits to You?
There are many ways to Volunteer your time and expertise to ISPE, including:
Get started now by accessing open Volunteer positions and completing a Volunteer Profile. Visit www.ISPE.org/Volunteers.
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Thursday, 19 May 2016 13.05
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Wednesday, 18 May 2016 13.05