Young Professionals Committee

Committee ChairBlake DerrickKelly 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: Business Ethics (Nov 2010) Financial Seminar (Jun 2011)

• Social/Networking Events: Sparians Spring Social (April 2011) Lonerider Brewery Tour (July 2011)

Young Professionals Committee

• Partnering with other committees Students – CASA Leadership Symposium Membership – Therapeutic Thursday

• Planning Meetings Once a month at Panera (Crabtree Valley

Mall)

What have the YPs been up to?

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 DerrickCASA Young Professionals Chair919-467-1752 (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

Committee ChairAmy Lineberry

SpecLine

Programs Committee

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

members

CPIP Study Program

CPIP OrganizerMarianne Lorenc

Medicago

ISPE Professional Certification

The Certified Pharmaceutical Industry ProfessionalTM (CPIPTM) For new and seasoned industry professionals An international competency-based credential Assessed by education, experience and examination

Value for the professionals Professional development pathway Enhanced career mobility Worldwide industry recognition

Value for Employers Global competency standard Recruiting and assessment tool Competitive edge

Conferred by the ISPE Professional Certification Commission

Founded in 1980Not-for-profit, non-lobbying global

professional society20,000 individual Members from more

than 90 countriesISPE is a Society of

pharmaceutical professionals who use expert knowledge to create high-quality, cost-effective GMP

solutionsProvides technological knowledge,

education, and guidance documents for pharmaceutical industry

Provides forums for exchange among industry, suppliers, academia, and

regulators

What is the ISPE

ISPE Overview & Structure

Founded July 1980 with focus on pharmaceutical engineering Chapter Formations in 1984, first Chapter New Jersey Today, Society has more than 20,000 members

90 countries 16 Chapters in North America 14 International Affiliates 25 Student Chapters worldwide

Expanded into Europe in 1988, opened office in 1992 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

Community• Communities of Practice • Local Affiliates/Chapters• Member Directory online 24/7

Profession• Certified Pharmaceutical

Industry ProfessionalTM (CPIPTM) certification program

• Career Exchange resources

Knowledge• 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

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 C O P s

• 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)

• 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

• Global Supplier’s Directory

• Regulatory and Industry News

• Reference Documents

• Global Events Calendar

• Global Career Exchange

• Featured Resources and Upcoming Events

• Online Membership Directory

• Pharmaceutical Engineering magazine articles: search and download

• Journal of Pharmaceutical Innovation articles: search and download

• Technical Glossary of Pharmaceutical Terms

• Communities of Practice

• Knowledge Briefs

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…

CaSA Chapter

Carolinas and South Atlantic Chapter

How do we fit in as

Chapter Charter

• Chapter Charter Charter is the bond between the Society and the Chapter

Authorizes the Chapter to operate as an official branch of ISPE

Charter is issued by the Chairman of the Society

Retained by ISPE HQ and the Chapter Manager

Approved annually by BOD, Signed by Officers, submitted to HQ

N A S A A C

North American South American

Affiliates and

Chapters

N A S A A C

North American Chapters Canada

Central Canada Chapter 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

South American Affiliates • Argentina Affiliate • Brazil Affiliate

Where are CaSA’s Members?

• 1240 CaSA members 858 in North Carolina 117 in Florida 78 in South Carolina 76 in Georgia 36 in Tennessee 8 in Alabama

• Across all areas of our industry

North Carolina

SC

ALTN

FL

GA

CaSA Chapter

So What Does the Future Hold

Let’s Hear from the BWGOR!

Jane Brown2007 ISPE Board

Chair

Contact ISPE

ISPE CaSA1500 Sunday Drive, Suite 102Raleigh, NC 27607Tel: +1-919-573-5442Fax: +1-919-787-4916Email: pkralka@firstpointresources.com

ISPE Headquarters 3109 W. Dr. M L King Jr. Blvd., Suite 250Tampa, Florida 33607 USATel: +1-813-960-2105 Fax: +1-813-264-2816Email: memberservices@ispe.org

Asia Pacific Office 73 Bukit Timah Road, #04-01 Rex HouseSingapore 229832Tel: +65 6496 5502Fax: +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 21-5116-0265Fax: +86 21-5116-0260Email: china@ispe.org

European Office Avenue de Tervueren, 300B-1150, Brussels, BelgiumTel: +32-2-743-44-22 Fax: +32-2-743-15-50Email: 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