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Young Professionals and Students

Young Professionals Education Sessions

Track Directors

Jennifer Lauria Clark, SE Mgr Technical Services, Commissioning Agents, Inc
Brody Stara, Validation Engineer, Commissioning Agents, Inc

This all-inclusive track is developed for young professionals or existing manufacturing professionals looking to enhance their education with the basics of good quality. The track contains dynamic sessions including round tables, case studies and proactive discussions on the quality aspects of critical utilities, GAMP®, facility design and many more!

Need a justification letter to attend? Find one in the Event Toolkit.


Project and Operating Challenge: Why are GCP Systems different (or not?)
Tuesday, 14 October: 08.15 - 09.30

In the GMP and the GLP world, principles on validation of computerized systems are well known and GAMP is established as an industry guideline for these processes. Over the years, the fundamental principles of the life cycle approach in GAMP have been expanded at a high level to be equally applicable across all GxP regulated industry areas. The proposed session addresses the specific GCP challenges and the following main questions: Why are GCP Systems different (or not)? How can GAMP principles be applied to address GCP System validation challenges?

  • Understand GCP Data & System challenges
  • Understand the project and operating phase during the conduct of clinical trials
  • Understand the importance of the project phase with regard to the operational phase
  • Describe and understand the GCP Process/Layer model - Understand the challenges on the different system layers
  • Analyze the GAMP principles (Project and Operating) with regard to the GCP requirements
  • Understand IT-Infrastructure as a layered system for GCP applications
Designing for Operational Excellence
Tuesday, 14 October: 10.15 - 11.30

An inefficient layout and design can increase operational wastes (i.e. non-value added activities), thereby negatively impacting the facility efficiency. Applying Lean Six Sigma techniques can be accomplished during the initial facility design to improve layout efficiency and minimize cost. Striving for Operational Excellence doesn't need to wait until a facility is operational. Op Ex and Lean procedures should be applied at the project concept. An inefficient layout and design can increase operational wastes (i.e. non-value added activities), thereby negatively impacting the facility efficiency. Lean wastes, particularly, excessive motion, transportation, waiting, and excessive inventory can be attributed to facility inefficiencies such as poor adjacencies, inadequately sized staging spaces and equipment. Applying lean six sigma techniques as part of the initial concept design phase can help reduce capital investment and operational expenses. Additionally, applying these techniques provide an opportunity to improve sizing and layout by optimizing travel paths, storage spaces, material handling equipment and processes.
In this presentation, the concept of incorporating lean six sigma tools and techniques during the design phase will be discussed. In addition, the following case studies will be presented to show the results that can be achieved.

  • Master Planning - Improving operations to meet forecasted demands, while minimizing capital investment and staffing expenditure.
  • Lean Facility Design - Understanding user requirements and operational issues during facility programming to optimize the layout with respect to travel paths and equipment sharing.
Competencies: A Strategy to Eliminate 483/Regulatory Observations
Tuesday, 14 October: 13.00 - 14.30
Develop a competency learning and training strategy to inspection-proof your organization while building a quality culture and employee engagement. For the last 5 years, training observations have ranked in the top 10 FD483 inspection observation for the pharmaceutical industry. Regulatory agencies, ISO, the Malcolm Baldrige Quality Award and other award and accreditation organizations have moved from asking if employees are trained, to documenting training, to documenting employee learning, to competencies.
The presenters show how their organization is moving from management of training to competencies. A well designed competency program demonstrates each employee's learning and their ability to complete and understand job tasks thus inspection proofing the organization to 483 and other agencies' training observations. It also provides employees with concrete training and job knowledge requirements and expectations which improves employee engagement.

This model also guides and supports organizational strategy to build and sustain a quality culture. Examples include competencies expected of employees throughout an organization such as quality, and customer service. Examples of competencies and lessons learned on how to design them will be provided. At the end of the session attendees will practice writing a competency.
  • Leader: Jan Hickey, M.S., CQE, RAC, Chief, CMS, VA Cooperative Studies Program, USA
  • Lincoln Mergard, Manufacturing Technician, VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, USA
Critical Utilities 101
Tuesday, 14 October: 15.30 - 17.00
Critical Utilities 102
Wednesday, 15 October: 08.00 - 09.15
This session will begin with an overview of critical utilities (water, clean steam, compressed air, and process gasses) and why the utilities are considered critical. The session will then review the critical design and installation requirements for water, clean steam, and process gas systems and how they relate to maintaining the critical quality attributes for the utility systems. This session is a continuation of Critical Utilities 101 and will cover an overview of quality monitoring and commissioning/qualification requirements for critical utility systems. Throughout the session, CU COP guides will be referenced to illustrate what information is available to Young Professionals from ISPE.

Call ISPE to register +1-813-960-2105.

Young Professionals Networking Events

Young Professionals/Student Luncheon

Who: A special luncheon and orientation for Young Professionals and Students
When: Sunday, 12 October 12.30 – 13.30

Enjoy lunch and fellowship with your young professional peers. You’ll meet other ISPE Members, learn about industry trends and make valuable connections to boost your career potential.

Realizing Your Career Potential - The Power of Planning

Are you struggling to get focused and find a challenging and successful pathway? This interactive discussion will help you understand the tools and assessments needed to guide you through your 1,3, and 5 year career plan. There will be discussions on mentoring, how to create opportunities for your career and professionals within the industry for you to share your ambitions and ask questions. During this discussion you will also glean more information on how to navigate through the pharmaceutical and biotech industries.

Featured Speakers

Jennifer Lauria Clark Photo

Jennifer Lauria Clark, SE Mgr Technical Services, Commissioning Agents, Inc.

LeAnna Pearson Photo

LeAnna Pearson,Sr. Validation Scientist, SpecLine Consulting

Young Professionals Morning Meet and Greet

Who: All are welcome to attend – Young Professionals, Students and veterans alike!

Monday, 13 October, 8.15 – 9.00
Tuesday, 14 October, 7.30 – 8.15
Wednesday, 15 October, 7.15 – 8.00

Join the Young Professionals Monday, Tuesday and Wednesday mornings for an opportunity to meet fellow attendees and learn about the educational sessions offered in the education track for young professionals. Brief introductions and overviews of the session topics will prepare you for each day’s education opportunities.

Young Professionals Networking Event at Margaritaville

Who: All are welcome to attend – Young Professionals, Students and veterans alike!
When: Monday, 13 October 19.30 – 22.00

Unwind from a busy day with an evening of food and fun with exciting island style entertainment hosted by ISPE’s Young Professionals. Share a glass of wine and heavy hors d’oeuvres while getting to know your industry peers (cash bar).

Margaritaville is located across the street from Caesars. Margaritaville is as much a state of mind as it is a place. From the moment you enter, you will be greeted with the sights and sounds of a festival-like atmosphere.

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