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Connecting Pharmaceutical Knowledge Great Lakes Chapter Fall 2017 Chapter Newsleer Deborah Geyman Quality Principal Auditor (Corp. Quality) Zimmer Biomet President’s Message Fellow ISPE Great Lakes Chapter Members, Thank you for your connued support of our Great Lakes Chapter through your membership and interest in our many acvies. As you may already know, your Chapter has produced several Webinars in 2017 with special subject Mater Experts speaking on topics that are of interest to you and your everyday working lives. We count on your connued support of the Great Lakes Chapter and are always interested in hearing from you on ideas to make the Chapter beer. Please contact me or any of the other Board Members for any suggesons or quesons about our Chapter acvies. Contact me at [email protected]

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Page 1: Great Lakes Chapter - Homepage | ISPE and...Results of our Chapter Election ommitment of each ISPE GL oard Member: As an elected ISPE oard of Director member, you take on responsibilities

Connecting Pharmaceutical Knowledge

Great Lakes Chapter

Fall 2017 Chapter Newsletter

Deborah Geyman

Quality Principal Auditor (Corp. Quality) Zimmer Biomet

President’s Message

Fellow ISPE Great Lakes Chapter Members,

Thank you for your continued support of our Great Lakes Chapter through your membership and interest in our many activities. As you may already know, your Chapter has produced several Webinars in 2017 with special subject Mater Experts speaking on topics that are of interest to you and your everyday working lives.

We count on your continued support of the Great Lakes Chapter and are always interested in hearing from you on ideas to make the Chapter better. Please contact me or any of the other Board Members for any suggestions or questions about our Chapter activities.

Contact me at [email protected]

Page 2: Great Lakes Chapter - Homepage | ISPE and...Results of our Chapter Election ommitment of each ISPE GL oard Member: As an elected ISPE oard of Director member, you take on responsibilities

Results of our Chapter Election

Commitment of each ISPE GLC Board Member:

As an elected ISPE Board of Director member, you take on responsibilities to represent the Great Lakes Chapter in the following ways:

You have volunteered and were elected by your Chapter peers to represent your Chapter to make a positive difference and to be a positive influence on you fellow Chapter members.

You will attend the monthly BOD meetings either in person or via conference call. If you cannot make the meetings, you will need to send out a response to let us know.

You will be asked to participate and support Chapter activities to the best of your ability. You will be required to attend at least one activity during your term (calendar year)

You will be asked to recruit, in you geographic area, new members for ISPE and for the Chapter.

Each of the Board Members are expected you to contribute to help build the Great Lakes Chapter by being a leader and an example for our pharma industry. Please help us make a difference.

President: Deborah Geyman

Vice President: Aaron Mertens

Treasurer: Tim Fry

Secretary: Andrea Frazer

Board Members:

David McAlonan

Larry Wessel

Allen Koester

Mike Carey

Sara Brothers

Bob Lennon

John Noble

Brian Grimes

Page 3: Great Lakes Chapter - Homepage | ISPE and...Results of our Chapter Election ommitment of each ISPE GL oard Member: As an elected ISPE oard of Director member, you take on responsibilities

Don’t Forget the ISPE Annual Meeting & Expo

We are hoping to have as many of the Great Lakes Chapter members attend and have a

time to have a ”Meet and Greet” of your chapter’s officers and Board of Directors. Our Chap-ter will be sending out more information on the time, date and place of this social hour just before the Annual Meeting.

More information on the ISPE please go to ISPE.org.

2017 ISPE Annual Meeting & Expo 29 October 2017 - 01 November 2017

San Diego, CA USA

Page 4: Great Lakes Chapter - Homepage | ISPE and...Results of our Chapter Election ommitment of each ISPE GL oard Member: As an elected ISPE oard of Director member, you take on responsibilities

Membership/ Become a member and grow with us! Discover the advantages of an ISPE Membership for every stage of your career. Whether you are new to the pharmaceutical industry or a seasoned professional, ISPE is your Society of Choice

Networking Opportunities

Whether networking at face-to-face events or collaborating online, the value of ISPE is in the links forged between industry professionals with common work challenges, connecting professionals and companies to practical guidance and dialogue between industry and global regulators. Membership Directory: Connect with 18,000+ other Members from nearly 90 countries around the world with the Membership Directory.

CoP Online Discussion Forums: Ask questions, find solutions to common problems and share your industry knowledge and expertise with colleagues from around the world. Learn more Affiliates and Chapters: Attend events, collaborate and share best practices in your local geographic region and language. Learn more Networking Events: Interact with fellow industry colleagues at a wide variety of face-to-face networking events at global ISPE conferences and the ISPE Annual Meeting.

Technical Resources

Guidance Documents, industry-leading publications, and on-demand training courses and webinars pro-vide practical information and solutions to real-world problems. Guidance Documents: Get special savings as an ISPE Member on industry Guides that provide the collective knowledge of leading thinkers on manufacturing best practices, regulatory compliance and international trends and best practices. Learn more Pharmaceutical Engineering Magazine: Your complimentary subscription to Pharmaceutical Engineering maga-zine gives you access to valuable information on the latest scientific and technical developments, regulatory initia-tives and innovative solutions to real-life problems and challenges. Learn more Review and Comment on Regulatory Guidance: Pharmaceutical professionals at all stages of their careers turn to ISPE for the latest regulatory information. Help shape your industry by providing input into ISPE’s official indus-try response to draft guidance from regulatory agencies around the world. Learn more

Professional Development

Industry-leading education and training, global volunteer opportunities and industry-focused career solu-tions allow ISPE Members to grow their professional knowledge and skills. Education and Training: Save on a variety of education and training programs, including ISPE global confer-ences, onsite training delivered at your company, online webinars and courses, and professional development and networking events conducted through your local Affiliate or Chapter. Volunteer Opportunities: Volunteer with ISPE to gain professional experience and recognition in the industry. ISPE Volunteers experience the personal benefits of volunteering while having the opportunity to make a differ-ence and influence the industry we serve. Learn more Career Solutions: Get noticed by the right people in our industry. Post your resume or job opportunity today to be seen by employers and job seekers specializing in the pharmaceutical and biotechnology industries.

Page 5: Great Lakes Chapter - Homepage | ISPE and...Results of our Chapter Election ommitment of each ISPE GL oard Member: As an elected ISPE oard of Director member, you take on responsibilities

The Facility of the Year Awards

Has your firm recently designed, built, or renovated a state-of-the-art pharmaceutical or biotechnology facility?

ISPE is seeking to recognize projects that demonstrate global leadership by showcasing cutting-

edge engineering, innovative new technology, or advanced applications of existing technology.

SUBMIT YOUR FACILITY TODAY

The Facility of the Year Awards are an annual program that recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, to reduce the cost of pro-ducing high-quality medicines, and demonstrate advances in project delivery.

The FOYA program is unique because it provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and opera-tion while sharing the development of new applications of technology and cutting-edge approaches that it is adopting.

Page 6: Great Lakes Chapter - Homepage | ISPE and...Results of our Chapter Election ommitment of each ISPE GL oard Member: As an elected ISPE oard of Director member, you take on responsibilities

2017 Facility of the Year Award Winners

Equipment Innovation, Cook Pharmica Facility Integration, Bristol Myers Squibb

Facility of the Future, Eli Lilly and Company Operational Excellence, Abbott

Process Innovation, Eli Lilly and Company Project Execution, Jazz Pharmaceuticals

Page 7: Great Lakes Chapter - Homepage | ISPE and...Results of our Chapter Election ommitment of each ISPE GL oard Member: As an elected ISPE oard of Director member, you take on responsibilities

Honorable Mentions

Nephron SC, Nephron Pharmaceuticals Corporation

Novartis-Penn Center for Advanced Cellular Therapies (CACT),

Biotech Facility, PT. Kalbio Global Medika

The program is about much more than just the science and technology of the facilities. More im-portantly, it's about recognizing the shared commitment and dedication of individuals working for different companies worldwide to innovate and advance pharmaceutical manufacturing technol-ogy for the benefit of all global consumers.

ISPE has developed the Facility of the Year Awards program to recognize the best newer reno-vated Pharmaceutical and Biotechnology manufacturing facilities that combine all aspects of the building into a superior working environment. The Judges Team consisting of prominent industry leaders with extensive global experience choose category winners and the overall Facility of the Year Award winner. The members of the FOYA committee represent a global cross-section of the pharmaceutical industry, as well as staff members from program co-sponsors ISPE.

Page 8: Great Lakes Chapter - Homepage | ISPE and...Results of our Chapter Election ommitment of each ISPE GL oard Member: As an elected ISPE oard of Director member, you take on responsibilities

Upcoming Conferences

2017 Asia Pacific GAMP Data Integrity

Conference 13 November 2017 - 14 November 2017 Singapore

2017 Europe Pharma 4.0 Conference 23 November 2017 - 24 November 2017 Pescantina Verona, Italy

2017 Biopharmaceutical Leadership Forum 03 December 2017 San Francisco, CA USA

2017 Biopharmaceutical Manufacturing

Conference 04 December 2017 - 06 December 2017 San Francisco, CA USA

2018 Facilities of the Future Conference 20 February 2018 - 22 February 2018 Bethesda, MA USA

2018 Aseptic Conference 06 March 2018 - 07 March 2018 Reston, VA USA

2018 Europe Annual Conference 19 March 2018 - 21 March 2018 Rome, Italy

2018 Quality Manufacturing Conference 04 June 2018 - 06 June 2018 Arlington, VA USA

Page 9: Great Lakes Chapter - Homepage | ISPE and...Results of our Chapter Election ommitment of each ISPE GL oard Member: As an elected ISPE oard of Director member, you take on responsibilities

Career Opportunities

For additional articles or what our Great Lakes Chapter can do for you, please contact

any of the Board of Directors or your Chapter President, Deborah Geyman at:

[email protected]