Helen Jun Natasha Nguyen Ashley Lai

BTE-SV Internship ProgramSummer 2012

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About Us

Helen Natasha Ashley

• Incoming senior

• Lynbrook High School

• Extra Curricular: Band, Volunteer clubs, school publications

• AP Biology under Ms. Della Santina

• Incoming sophomore

• Piedmont Hills

• Enjoys writing and gaming

• Biology with Mr. Kregear

• Incoming senior

• Leland High School

• Extra Curricular: Speech, Piano, Journalism

• Enjoys drawing, graphic design, and painting

• AP Biology with Mrs. Anu Sarkar

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Expectations

• Application of skills – Project management, detail-oriented/ organizational

skills

• Experience in a professional environment– Intrapersonal relations– Ambience of medical company

• Independent Work– Limited interaction with other interns/ employees

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G.P.L.

• Medical Device Company: FDA regulations, high-risk

• Programs Used: daVinci, ENABLE• Manages packaging and labeling for

the entire LifeScan franchise– recently launched VerioIQ™ and VerioPro™ in EMEA, US, Canada, and APC

“Leading the accelerated delivery of packaging and labeling solutions that exceed

our global customers' needs”- GPL Mission Statement

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Teams Within GPL

• Project Managers

• Artwork Specialists

• Content Management

• Packaging Engineers

• Process Improvements

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• Orientation Ice Breaker• Communication/Collaboration

– Diabetic Youth Foundation Fundraiser– Credo Activity– Interaction between different GPL team functions

Teamwork

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Project ObjectivesHelen Natasha Ashley

Understand/ execute parts of packaging and labeling development process

Focus on the validations process

Aid in miscellaneous tasks/ responsibilities of packaging engineers, such as BOM reviews/ weights

Drive automation through workflow testing

Manage global relations and records

Develop efficient communication skills

Add clarity & update redundant WI

Develop artwork following the packaging and labeling process

Label verification of artwork to global content requirements

Create ENABLE routes to support AW approval

Provide assistance to global specialists on base business activities

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• Works closely with many different branches– Graphics Vendors,

Marketing, In-Country Reviewers, Regulatory, Quality, etc.

– Must communicate w/ all branches

• Responsible for creating, revising, reviewing, and routing AW

Artwork Specialists

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Overview of Artwork Process

AW Project Creation

Initiate New or Revised Artwork

Prepare AW Input Documentation

Develop Translation and

Artwork

In-Country Review and

Approval

Generate Final Files

Perform Verification of Final Artwork

Prepare, Approve and Submit

Change Documentation

P.E. provides

ADS---------------

Develop Core CPS if needed

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• Training for daVinci and Enable– Web-based project management tools– daVinci holds documents in progress,

while Enable holds released documents– Additional training to become Matrix Originator on Enable

• Shadowing LVAs– Spent first few weeks watching others perform LVAs before I

could do perform one myself

• Global Communication– Many other personnel involved in workflow are based in sites in

other countries– Must take the time differences in consideration when working to

meet a deadline

Preparation and Challenges Faced

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Main Job/Responsibility

• Managed Process of Updating 4 Labels for APC– Legend on artwork (AW)

was missing (zug) on title– Collaboration via daVinci

and Enable– Communicated with team

members to ensure workflow ran smoothly

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• General– Read out content w/ all punctuation and capitalization– Requires at least two people to review artwork

• Global Content (GC)– Acts as a template and input document– Displays required contents in black and localizable text in blue– Managed by Content Management team

• Type 1 LVAs– Requires adherence to Global Content– Ex. Cartons, Owner’s Booklets

• Type 2 LVAs– Does not require Global Content– Ex. Warranty Card or Promotional Materials

Label Verification of Artwork (LVAs)

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Miscellaneous Tasks• SKU Matrix

– Cross-check project components on Excel

• Updating Records– Ensure that Work

Instruction (WI) records are still accurate

• Testing Preparation– Pack and check cases

to catch any prior damage before testing

• SGS Procedures– Prepare for audit by

updating SGS binder• Parts Disposition

Notifications (PDNs)– Determine what to do

with existing batch after revision

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Packaging Engineering

• Ranges from design conceptualization to product placement

• Interacts w/ Research & Development, Manufacturing, Marketing, Graphic Design, Regulatory, Purchasing, Planning

• Package must sell/ protect product; be environmentally friendly, cost-effective

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Validation

• Purpose: to ensure the customer receives a safe, usable product and to prevent possible injuries

• FDA as well as company regulations must be followed

• Steps for Validation– Pre-test, samples (GDM, LifeScan employees)– Testing (Westpak, LifeScan employees)– Post-test (GDM, LifeScan employees, Westpak)

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Pre-test inspection

• Pre-test inspection: prepare 200 carry cases (2x100) and their components based on acceptance criteria

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Testing• Drop, Compression, and Bounce testing at Westpak, Inc. • Followed by post-test inspection• 99% pass rate required• Result: failure; tested new configuration, which passed

change in report

Bounce machine: stimulates running

Drop machine Compression machine

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Westpak, Inc.Vehicle Vibration Test

ChamberBounceDrop

Compression

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• BOM review• SKU matrix cross check• LVA (check- GC, deviations)• Validations Database• BOM Weights

Other Tasks

Validations Database

BOM

SKU matrix

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• Learning how to navigate ENABLE• Understanding the different steps to tasks like BOM

reviews, validations, etc.

Challenges Faced

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Process Improvement

s

Drives automation

Develops and improves processes to add company value

Reduces resource use by designing solutions

Manages global relations and trains partners

Maintains processes/systems/procedures implemented

Resolves process gaps and troubleshoots issues

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Process Challenges

Increasing demands with less resources

Resistance to change

Balancing preferences vs. requirements

Tailoring/compromising program use to meet everyone’s needs 

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My Projects

Emboss Workflow

PLA Workflow

BOM Workflow

Created separate workflow because main workflow was disturbed by sub-

workflows.

New automated process for project

planning and design control packaging

labeling assessments.

Updated BOM workflow to support

PLA workflow.

Through daVinci, went through the workflows as test users for each of the task owners. I then made sure the specified task was activated and completed as expected. Each time, the stages were either locked or not, depending on how queries were answered. Every path had to be taken to ensure that there were no discrepancies.

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LVA Work Instruction Update

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Audit Binder

• Communicated with global ICR approvers to ensure we had the latest training records.

• Answered their questions and followed up with every person – over 120 people.

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Highlights

Improving Excel andPowerPoint Skills

Helping the CommunityOn Credo Day

Testing ActualLifeScan Products

CommunicatingGlobally

Meeting/Interacting w/ So Many People

The Best Food!

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What We Learned

• Intricacy of GPL work flows, processes, regulations, and tasks

• ENABLE/ daVinci

• Project/time management; organizational skills

• Experience in various work settings

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• GPL Credo event: LifeScan mission statement• “We are responsible to the communities in which we

live…” –Johnson & Johnson credo

Giving Back to the Community

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• Learned about new careers in revolutionizing minimally invasive surgery

• Had the opportunity to test out the robots• New technology helps both patients and doctors

– Significantly shorter patient recovery time– Doctors don’t get fatigued as easily, so they can concentrate and

perform better

Company Tour: Intuitive Surgical

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• Learned about how to use Linked-In to find job opportunities• Importance of professionalism on Internet with lack of

privacy settings• Networking Activity

– Met with members of LifeScan’s Sales Leadership Association to learn networking and ask about college and career advice

Linked-In Workshop

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Mary Lou Stuart

Dr. Katy Korsmeyer

Elizabeth Judd-Cummings

Yvonne Chen

Sheryll Dacon

Jabela Kundalia

Stephanie Little

Joe Tungol

GPL Department

Special Thanks to

“Creating a world without limits for people with diabetes.” – LifeScan Mission Statement

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