Young Professionals Committee Chair Blake Derrick Kelly Scientific

Young Professionals Committee Chair Blake Derrick Kelly Scientific

Young Professionals Committee Mission Statement: A forum that would provide unique opportunities for young professionals to network, socialize, foster mentorship and share ideas with their peers to promote career development in the pharmaceutical, biotech and medical device industries.

Young Professionals Committee What have the YPs been up to? • Educational Events: w Business Ethics (Nov 2010) w Financial Seminar (Jun 2011) • Social/Networking Events: w Sparians Spring Social (April 2011) w Lonerider Brewery Tour (July 2011)

Young Professionals Committee What have the YPs been up to? • Partnering with other committees w Students – CASA Leadership Symposium w Membership – Therapeutic Thursday • Planning Meetings w Once a month at Panera (Crabtree Valley Mall)

Young Professionals Committee How do I get started? Sign up by having your email on our contact list and you can begin receiving communications about events Blake Derrick CASA Young Professionals Chair 919 -467 -1752 (office) casayoungprofessionals@gmail. com Email or call me if you’re interested in joining the Planning Meetings at Panera! We have a spot for you!

Programs Committee Chair Amy Lineberry Spec. Line

Programs Committee Providing innovative and one-of-a-kind training opportunities for our members

CPIP Study Program CPIP Organizer Marianne Lorenc Medicago

ISPE Professional Certification The Certified Pharmaceutical Industry Professional. TM (CPIPTM) w For new and seasoned industry professionals w An international competency-based credential w Assessed by education, experience and examination Value for the professionals w w w Professional development pathway Enhanced career mobility Worldwide industry recognition Value for Employers w w w Global competency standard Recruiting and assessment tool Competitive edge Conferred by the ISPE Professional Certification Commission

What is the ISPE Founded in 1980 Not-for-profit, non-lobbying global professional society 20, 000 individual Members from more than 90 countries ISPE is a Society of pharmaceutical professionals who use expert knowledge to create high-quality, costeffective GMP solutions Provides technological knowledge, education, and guidance documents for pharmaceutical industry Provides forums for exchange among industry, suppliers, academia, and regulators

ISPE Overview & Structure Founded July 1980 with focus on pharmaceutical engineering w Chapter Formations in 1984, first Chapter New Jersey w Today, Society has more than 20, 000 members § 90 countries § 16 Chapters in North America § 14 International Affiliates § 25 Student Chapters worldwide w Expanded into Europe in 1988, opened office in 1992 w ISPE operates out of 4 offices: § HQ in Tampa, Florida • Brussels, Belgium • Asia Pacific Office • China Office

ISPE Membership is Global

ISPE Assists its Members? ISPE provides: • access to regulatory and industry news, information, and resources • practical application education and training • skills and knowledge for the future • global and local networking opportunities

Membership Has Its Benefits Knowledge Community • ISPE’s Body of Knowledge • Global resources through the Society’s Web site at www. ispe. org • Pharmaceutical Engineering magazine • Technical Documents • Education and Training • Online Learning • Communities of Practice • Local Affiliates/Chapters • Member Directory online 24/7 Profession • Certified Pharmaceutical Industry Professional. TM (CPIPTM) certification program • Career Exchange resources

ISPE Communities of Practice Purpose • Provide a forum for community members to help each other solve everyday work problems • Develop and disseminate best practices, guidelines, and procedures while creating breakthrough ideas, knowledge, and practices • Organize, manage, and research a Body of Knowledge from which community members can draw Connecting members person-to-person Collecting relevant information to share

Current • Active Pharmaceutical Ingredients (API) • Biotechnology (Bio) • Commissioning and Qualification (C&Q) • Containment • Critical Utilities (CU) • Disposables • Engineering Standards Benchmarking (ESB) • Good Automated Manufacturing Practice (GAMP®) • Good Control Laboratory Practices (GCLP) COPs • Heating, Ventilation, and Air Conditioning (HVAC) • Investigational Products (IP) • Operations Management • Oral Solid Dosage (OSD) • Packaging • Process Analytical Technology (PAT) • Process/Product Development (PPD) • Project Management (PM) • Sterile Products Processing (SPP) • Sustainable Facilities

Your 24/7 Access Point • Online Membership Directory • Global Supplier’s Directory • Pharmaceutical Engineering magazine articles: search and download • Regulatory and Industry News • Journal of Pharmaceutical Innovation articles: search and download • Technical Glossary of Pharmaceutical Terms • Communities of Practice • Knowledge Briefs • Reference Documents • Global Events Calendar • Global Career Exchange • Featured Resources and Upcoming Events

ISPE Technical Contributions • 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.

Who Are ISPE’s Members? Global pharmaceutical professionals who work in every aspect of the pharmaceutical industry

ISPE Members Work in…

Ca. SA Chapter How do we fit in as Carolinas and South Atlantic Chapter

Chapter Charter • Chapter Charter w Charter is the bond between the Society and the Chapter w Authorizes the Chapter to operate as an official branch of ISPE w Charter is issued by the Chairman of the Society w Retained by ISPE HQ and the Chapter Manager w Approved annually by BOD, Signed by Officers, submitted to HQ

NASAAC North American South American Affiliates and Chapters

NASAAC South American Affiliates • Argentina Affiliate North American Chapters w Canada • Brazil Affiliate § Central Canada Chapter w United States § § § § Boston Area Carolinas-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

Where are Ca. SA’s Members? • 1240 Ca. SA members w 858 in North Carolina w 117 in Florida w 78 in South Carolina w 76 in Georgia w 36 in Tennessee w 8 in Alabama • Across all areas of our industry

Ca. SA Chapter SC TN North Carolina FL GA AL

So What Does the Future Hold

Let’s Hear from the BWGOR! Jane Brown 2007 ISPE Board Chair

Contact ISPE Ca. SA 1500 Sunday Drive, Suite 102 Raleigh, NC 27607 Tel: +1 -919 -573 -5442 Fax: +1 -919 -787 -4916 Email: pkralka@firstpointresources. com ISPE Headquarters 3109 W. Dr. M L King Jr. Blvd. , Suite 250 Tampa, Florida 33607 USA Tel: +1 -813 -960 -2105 Fax: +1 -813 -264 -2816 Email: memberservices@ispe. org Asia Pacific Office 73 Bukit Timah Road, #04 -01 Rex House Singapore 229832 Tel: +65 6496 5502 Fax: +65 6336 6449 Email: asiapacific@ispe. org China Office Suite 2302, Wise Logic International Centre 66 North Shan Xi Road, Shanghai, China 200041 Tel: +86 21 -5116 -0265 Fax: +86 21 -5116 -0260 Email: china@ispe. org European Office Avenue de Tervueren, 300 B-1150, Brussels, Belgium Tel: +32 -2 -743 -44 -22 Fax: +32 -2 -743 -15 -50 Email: ispe@associationhq. com Visit www. ISPE. org for more information.

There is so much to cover – and so little time Thank you for your participation and support of our Board