ispe: a catalyst for change
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Founded in 1980
Not-for-profit, non-lobbyingglobal professional society
25,000 individual Members from 90 countries
Provides technological knowledge, education, and guidance documents for pharmaceutical industry
Provides forums for exchange among industry, suppliers, academia, and regulators
Strong ties with regulatory authorities worldwide
Who Are ISPE’s Members?ISPE connects pharmaceutical professionals globally from development through delivery.ISPE Members represent the full circle of knowledge required for innovation: • Industry professionals from companies that manufacture
Pharmaceuticals, Biopharmaceuticals, APIs, Veterinary Medicine, Generics, Medical Devices and Diagnostics
• Service Providers and Suppliers of Equipment
• Regulatory Authority Leaders
• Academics and Students
ISPE Membership Expertise• Architect / Engineer /
Construction• Clinical / Investigational
Materials• Health / Safety / Environmental• Information Technology• Logistics/Supply Chain
Management• Maintenance• Operations / Manufacturing• Process Control/Automation• Process Development /
Technology Transfer
• Project Management• Quality Assurance/Control• Regulatory/Compliance• Research and Development• Sales / Marketing /
Business Development• Technical Services /
Product Support• Training• Validation / Qualification /
Commissioning
How does ISPE Assist its Members?
• Provides access to regulatory and industry news, information, and resources
• Provides practical application education and training needed to “get the job done” today, while equipping you with the skills and knowledge needed for tomorrow’s challenges
• Provides global and local networking opportunities through Communities of Practice and Affiliates and Chapters that foster collaboration and sharing
What Does ISPE Provide to Members?Networking Opportunities• Communities of Practice • Local Affiliates/Chapters• Member Directory on-line 24/7• Global On-line Career
Exchange
Professional Growth• Education and Training• Certified Pharmaceutical
Industry Professional (CPIP™) credential
• On-line learning
Critical Information• ISPE’s Body of Knowledge• Global Resources through the
Society’s Web site at www.ISPE.org
• Pharmaceutical Engineering magazine
• Peer-reviewed Journal of Pharmaceutical Innovation
• Technical Documents
Communities of Practice (COPs)Purpose• Provides forum for community
members to help each other solve everyday work problems
• Develops and disseminates best practices, guidelines, and procedures, and creates breakthrough ideas, knowledge, and practices
• Organizes, manages, and researches a Body of Knowledge from which community members can draw
•Connecting members person-to-person•Collecting relevant information to share
Communities of Practice (COPs)Current COPs:• Active Pharmaceutical Ingredients (API)• Biotechnology • Commissioning and Qualification • Containment • Critical Utilities• Disposables • Good Automated Manufacturing Practice (GAMP®)• Heating, Ventilation, and Air Conditioning (HVAC)• Investigational Products • Packaging• Process Analytical Technology• Process/Product Development• Project Management • Sterile Products Processing
Emerging Economy Members
• Industry professionals from countries the World Bank classifies as “Emerging Economies”
• Membership Dues: $30/ €30 year
• Full Society benefits with electronic access to publications
Student Members
• Special resources and events to help develop your career
• Networking opportunities with top professionals in your field tofine-tune skills and develop interviewing practices
• More than 40 Student Chapters supported by local ISPE Affiliates and Chapters at colleges and universities worldwide
• Membership Dues: $15/ €15 per year ($5/ €5 per year for Emerging Economy countries)
International Student Members
AustraliaAustriaBelgiumCanadaChinaCzech RepublicDominican RepublicFinlandFranceGermanyIndiaIndonesiaIreland
ItalyJordanKoreaMalaysiaMexicoPolandSingaporeSwedenSwitzerlandTaiwanTurkeyUnited KingdomUnited States
Student Members represent the following countries:
How is ISPE Global and Local?
• 90% of ISPE Members belong to an Affiliate or Chapter
• ISPE Members take global issues and determine local solutions…in the local language
• Affiliate/Chapter events provide a forum for transfer of industry/regulatory information and technology on a local basis and access to:• Educational seminar/training programs• Industry/regulatory/academia/professional networking• Facility tours
• Affiliate/Chapter Web sites deal with regional topics in local language
Affiliates/Chapters: Asia Pacific
Asia Pacific Affiliates• Australasia
• Brisbane Chapter• Melbourne Chapter• New Zealand Chapter• Sydney Chapter
• India• Japan• Singapore• Thailand
In Development• China• Indonesia
Affiliates/Chapters: EuropeEuropean Affiliates
• Belgium• Czech Republic/
Slovakia• France• Germany/Austria/
Switzerland• Ireland• Italy• Nordic• Poland
• Spain • The Netherlands• Turkey• United Kingdom
• Central Region• Northeast Region• Northwest Region• Scotland Region• Southern Region
Affiliates/Chapters: North/South America
North American Affiliates• Canada Affiliate
• Central Canada Chapter• United States Affiliate
• Boston Area• Carolina-South Atlantic• Chesapeake Bay Area• Delaware Valley• Great Lakes• Greater Los Angeles Area• Midwest
• New England• New Jersey • Pacific Northwest• Puerto Rico• Rocky Mountain• San Diego • San Francisco/Bay Area• South Central
South American Affiliates • Argentina Affiliate • Brazil Affiliate
ISPE Web siteYour 24/7 Access Point to Knowledge
www.ISPE.org
• On-line Membership Directory
• Pharmaceutical Engineeringmagazine articles: search and download
• Journal of Pharmaceutical Innovation articles: search and download
• Technical Glossary of Pharmaceutical Terms
• Communities of Practice
• Global Supplier’s Directory
• Regulatory News
• Reference Documents
• Global Events Calendar
• Global Career Exchange
ISPE Professional CertificationThe Certified Pharmaceutical Industry Professional (CPIPSM)
• An international competency-based credential• Eligibility requirements (Bachelor's degree + demonstrated
industry experience)• Written examination
Value for the professional:• Enhanced career mobility• Competitive edge
Value for the employer:• Global competency standard• Recruiting tool
Conferred by the ISPE Professional Certification Commission
ISPE’s Technical Contribution to the Industry
• Baseline® Pharmaceutical Engineering Guides• Good Automated Manufacturing Practice (GAMP®) • ISPE Good Practice Guides • Providing technical input to regulatory authorities
such as US FDA, EMEA, JMHLW, WHO, and PIC/S
The ISPE logo, tagline, GAMP, and Baseline are registered trademarks of ISPE.
Baseline® Pharmaceutical Engineering Guides
Currently Available• Active Pharmaceutical
Ingredients, a revision of Bulk Pharmaceutical Chemicals
• Oral Solid Dosage Forms• Sterile Manufacturing
Facilities• Water and Steam Systems• Commissioning and
Qualification• Biopharmaceutical
Manufacturing Facilities
Upcoming Guides• Packaging, Labeling, and
Warehousing Operations(2007)
• Maintenance (2008)• Laboratories (2008)
ISPE Industry Guidance• GAMP® 4, Good Automated Manufacturing Practice Guide for
Validation of Automated Systems• GAMP® 5, Good Automated Manufacturing Practice Guide for
Validation of Automated Systems - 1st quarter 2008
• Currently Available GAMP® Good Practice Guides• Calibration Management• Validation of Process Control Systems• A Risk-Based Approach to Compliant Electronic Records and
Signatures• Validation of Laboratory Computerized Systems• IT Infrastructure Control and Compliance• Global Information Systems Control and Compliance• Testing of GxP Systems• Electronic Data Archiving
ISPE Industry GuidanceISPE Good Practice Guides Currently Available
• Comprehensive Guide to Clinical Materials• ISPE Good Practice Guide: Technology Transfer• ISPE Good Practice Guide: Assessing the Particulate Containment
Performance of Pharmaceutical Equipment• Commissioning and Qualification of Pharmaceutical Water and Steam
Systems• Biologics for Clinical Materials Professionals
Technical Documents Under Development• Baseline Guide: Risk Based Manufacture of Active Pharmaceutical Products
(Risk–MaPP) • Baseline Guide: Biopharmaceutical Process Development and Manufacturing • ISPE Good Practice Guide: Good Engineering Practice• ISPE Good Practice Guide: HVAC• ISPE Good Practice Guide: Pharmaceutical Testing Laboratories• ISPE Good Practice Guide: Science and Risk-Based Cleaning Process
Development and Validation
Facility of the Year Awards (FOYA)• Competition recognizing state-of-the-art
pharmaceutical manufacturing projects that utilize new / innovative technologies to improve quality and reduce costs
• Program provides a platform to showcase new products and accomplishments, and share of development of new applications in the areas of:
• Process Innovation• Project Execution• Equipment/Innovation• Facility/Integration• Energy Efficiency• Operational Excellence
Contact ISPEISPE Headquarters3109 W. Dr. M L King Jr. Blvd., St 250, Tampa, Florida 33607 USATel: +1-813-960-2105 Fax: +1-813-264-2816E-mail: [email protected]
European OfficeAvenue de Tervueren, 300, B-1150, Brussels, BelgiumTel: +32-2-743-44-22 Fax: +32-2-743-15-50E-mail: [email protected]
Asia Pacific Office73 Bukit Timah Road, #03-01 Rex House, Singapore 229832Tel: +65 6496 5502 Fax: +65 6336 2263E-mail: [email protected]
Visit www.ISPE.org for more information