International Society for Pharmaceutical Engineering

About ISPE

The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland, USA, and an operations and training center in Tampa, Florida, USA.

Contents

• International society for pharmaceutical engineering sligo seminar
• About ISPE
• Structure
• Communities of Practice CoPs
• Education and Training
• Guidance Documents
• Affiliates and Chapters
• Product Quality Lifecycle Implementation
• Facility of the Year Awards Program
• References

Structure

Along with joining a global society, professionals join a local affiliate or chapter to network and collaborate with like-minded professionals in their native language. In addition to local and global networking opportunities, ISPE offers access to industry-standard technical documents, peer-reviewed publications, industry and regulatory resources, relevant continuing education and training, and the first competency-based international certification for pharmaceutical professionals.

The official ISPE web site (http://www.ispe.org) provides industry professionals with access to a body of knowledge, and includes information including regulatory updates, industry news, a glossary of applied terminology, a global calendar of education and training events, Communities of Practice (CoPs), discussions, technical documents, and publications, Pharmaceutical Engineering magazine.

Communities of Practice (CoPs)

Through interactive online CoPs, industry professionals can access bodies of knowledge, share best practices, as well as contact and engage in networking opportunities with other like-minded colleagues.

CoPs allow participants to:

Education and Training

ISPE’s conferences allow peers to share problems and develop solutions through educational programming, networking activities, and interaction with regulatory leaders. ISPE draws from the expertise of its members to develop courses that address industry needs. Training instructors provide technical knowledge and skill acquisition through small classes designed to enhance interaction. ISPE also offers onsite and technology-based learning opportunities.

Guidance Documents

ISPE’s Guidance Documents are written by industry experts and result from global collaboration — including participation and review by regulatory agencies. Produced by pharmaceutical science and manufacturing industry professionals, ISPE publications provide information to help companies build on best practices to meet regulatory standards.

Affiliates and Chapters

ISPE members can take advantage of ISPE resources on a local level through more than 40 ISPE Affiliates and Chapters that offer educational and networking opportunities. They can interact with colleagues and attend events.

Product Quality Lifecycle Implementation

ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative resulted from the need to help the pharmaceutical industry find global solutions to implementation challenges for International Conference on Harmonization (ICH) guidances. Through PQLI (www.ISPE.org/PQLI), ISPE spearheads efforts to work with industry and regulatory leaders worldwide to develop implementation of ICH guidances.

Facility of the Year Awards Program

The Facility of the Year Awards program (www.facilityoftheyear.org) recognizes pharmaceutical manufacturing projects that utilize innovative technologies to enhance the delivery of a quality project, as well as reduce the cost of producing medicines.