2017 Summer Internship Presentation

Jin Park
Adam Barth
Danielle LeBleu
Radhika Sharma
Brandon Harris
Table of Contents

I. QA - Adam

II. Marketing - Danielle

III. MM - Brandon

IV. AD - Radhika

V. IT - Jin
QA Internship

Adam Barth
 About Me

Roswell, GA

Major: Finance and Management Information System (MIS) at UGA

Experience:

Flight Operations

Live-Video Production

Transportation Operations

No previous pharmaceutical experience/knowledge

 Areas of Focus

Raw materials and Excipient Risk Assessments

FDA Quality Metrics

Production Delay Diagnosis and Reduction

Process Improvement
Excipient Risk Assessment

Gauge risk on suppliers that we are unable to audit

Comply with new EU guidelines

Created new risk matrix with detectability

Assigned summary risk values to every supplier

 Excipient Risk Assessment
Consequences

Risk Matrix None - 0 Minor - 1 Moderate - 2 Major - 3 Severe - 4

Total Assumption of
Detectability Matrix Risk

Neutralconsequenceor
Noconsequence; minoreffectcorrectable Minorconsequence; Significantaffect; Major"Game Verydifficulttodetect
NotApplicable quickly/instantly.Lowrisk Lowriskofharm. Riskofmoderate Changing"affect; Very Difficult - 4 /Undetectable 4 VeryHigh-4 48 - 64
harm RiskofSevereHarm
ofharm
Highrisk;Strong
recommendationto
reevaluateactivityor
Probability relationship

Likely - 4 Giventime,failureis
likelytooccur 0 4 8 12 16 X Difficult - 3 DifficulttoDetect 3 = High-3 Moderaterisk;Evaluateriskof
activityorrelationship 32 - 47

Failurewillprobably Lowrisk/ComfortableRisk;
Moderate
High - 3 occurinmany 0 3 6 9 12 Moderate - 2 Detectability 2 Moderate-2 Monitoractivityor 16 - 31
circumstances relationshipasnormal

Failuremayoccur Verylowriskornoriskatall;
Obvious/Easyto
Moderate - 2 onlyinoutstanding 0 2 4 6 8 Easy- 1 Detect 1 Low-1 Comfortableinall 0 - 15
circumstances circumstances

Failuremayoccur
Low - 1 once,ifever 0 1 2 3 4

Failurewillnotoccur;
None - 0 notapplicable 0 0 0 0 0 14
 Excipient Risk Assessment
Percentageof
Probabilityof manufacturer's Presenceofcleaning Hasthissiteever
Purposeand CurrentManufacturing Component'ssafety Component'susein Supplier'sreputationin productline Possibilityofcomponents ProbabilitythatRecrowill productionofthis Accreditationof AuditHistory programsformajor Levelofadherenceto Availabilityandoutcome Historicalpassrate Timemanufacturer beeninan Formofthefinal Potentialfor Potentialfor Potentialfor Potentialforimpurities
Criticalityofmaterial Phase/possibilityof andeffectiveness pharmaceuticalorfood Compendialstatusof pharmaceuticalorfood Companysizeand continuingtobe beingsuppliedbymore benotifiedofachangein componentusedby supplierbyaquality withFDAor equipment;cleaning cGMPsbasedon ofaRecroauditreportfor ofbatchesreceived hasbeenproducing Unapproved productsmade Potentialforviral Micro/endotoxin/pyrogen impuritiesfrom impuritiesfrom fromcross- Sterilityassurance, Environmentalcontroland Supply-chain Document SummarizedRisk
inourprocess laterphase GRAS industries material industries financialstability made thanonesupplierlocation manufacturinglocation pharmaindustry system EMEA validation QualityQuestionnaire thefacility byRecro theproduct Status? withtheitem TSE/BSERisk contamination contamination rawmaterials processes contamination ifapplicable storage/shippingconditions complexity PackagingIntegrity Compliance Factor

3001721
AshllandSpecialtyIngredients Povidone 8 4 2 1 1 3 1 2 1 6 1 9 2 2 4 1 1 1 4 0 1 1 6 6 6 0 12 1 4 9 228

Detectability 2 2 2 1 1 1 2 3 2 3 2 3 3 2 1 1 2 1 2 1 2 2 2 2 4 1 3 2 1 2

3001728
ArroPackaging CitricAcid 2 9 1 4 6 6 2 4 1 70

Detectability 2 2 2 2 2 2 2 2 2

3001764
BartekIngredients,Inc. FumaricAcid 4 1 1 1 1 6 9 4 4 4 1 1 1 1 1 1 1 1 0 4 4 1 119

Detectability 2 2 2 2 2 2 3 3 3 2 2 1 1 1 1 1 1 2 1 2 3 2

AllEmptyShells
Capsugel AllEmptyShells 16 1 1 1 1 6 1 9 4 1 1 1 1 12 12 1 4 1 4 4 0 4 1 1 213

Detectability 3 2 2 2 2 2 2 2 2 2 1 1 1 3 3 2 2 2 2 2 1 2 2 2

3001741
ClariantGmbH PolyethyleneGlycol6000 3 1 1 1 2 2 6 4 1 1 4 4 4 1 6 3 3 3 3 4 4 4 123

Detectability 2 1 1 2 2 2 3 3 2 2 2 3 1 1 1 2 2 2 2 1 1 2

3001725

ColorconInc. SugarSpheres30/35mesh 9 2 4 1 1 4 2 4 2 12 8 3 3 6 1 2 144

Detectability 2 2 2 2 2 3 2 2 2 3 2 2 2 2 2 2

3001784
DowChemical EdetateDisodiumUSP 4 1 1 1 6 6 1 2 12 9 4 9 134

Detectability 2 2 2 2 2 2 2 2 2 3 3 3

3001831
DowChemical PolyoxWSR 1 1 6 1 9 1 6 8 9 4 101

Detectability 2 2 2 2 2 2 2 2 3 2

Eudragit
EvonikRohm Eudragit 6 6 3 1 2 3 6 4 3 9 80

Detectability 1 1 1 2 2 2 2 2 2 3

3001723
DenaturedDehydratedAlcohol
EquistarChemicals,LP (SDA3a) 3 3 3 1 1 1 1 1 6 8 1 2 2 4 1 1 1 1 8 0 3 3 3 3 3 0 3 1 2 2 134

Detectability 1 2 2 1 1 2 2 2 3 3 2 2 2 2 1 1 1 1 1 1 2 2 2 2 2 1 1 2 1 1

3001795
DenaturedDehydratedAlcohol
EquistarChemicals,LP (SDA3c) 6 9 9 2 3 1 1 1 4 4 2 2 2 1 4 4 1 3 0 1 1 2 4 1 0 132

Detectability 1 2 2 2 1 1 2 2 3 3 2 2 2 2 2 3 1 1 1 1 1 2 2 2 1

3001722
ExxonMobilChemical IPA 6 4 2 2 1 1 1 2 4 2 1 16 16 6 1 1 1 0 2 3 3 3 3 0 16 4 2 215

Detectability 1 2 2 2 2 2 2 3 2 2 2 3 2 2 2 2 1 1 1 2 2 2 2 1 2 2 2

3001765
GraceDavison(W.R.Grace) SiliconDioxide 1 1 1 1 1 1 1 6 2 1 8 2 2 1 1 0 4 4 3 3 0 3 6 1 6 109

Detectability 1 2 1 2 2 2 2 2 2 2 2 2 2 1 1 1 2 2 2 2 1 2 2 1 1

3001720
Imerys Talc 6 1 1 1 1 2 1 4 2 1 1 2 1 1 1 1 4 0 2 9 4 1 1 0 6 1 4 2 114

Detectability 1 1 2 1 2 2 3 3 3 2 2 2 2 1 1 1 1 1 2 2 2 2 2 1 2 2 2 2

3001840
IMIFabiLLC Talc 1 1 1 2 1 2 6 1 4 4 6 1 1 1 0 8 4 4 1 0 4 1 1 16 181

Detectability 1 2 1 3 2 2 3 2 3 3 2 1 1 1 1 3 3 2 2 1 2 2 2 3

3001727
INEOSPhenol Acetone 6 1 2 1 1 1 2 4 4 1 9 4 1 1 1 1 1 4 1 1 1 94

Detectability 2 2 2 2 2 2 3 2 2 2 2 2 2 1 1 3 1 1 2 2 2 2

3001733
Powdersize FumaricAcid 16 4 6 1 1 4 16 2 2 1 1 1 117

Detectability 1 3 2 2 2 3 3 2 2 1 2 2

3001843
PentaManufacturingCompany SucroseOctaacetate 1 4 2 2 2 2 1 2 6 1 9 4 4 4 4 9 1 1 1 0 3 3 3 0 4 170

Detectability 1 1 1 2 2 2 2 3 3 1 2 3 3 3 3 3 2 1 2 1 2 2 2 1 2

3001729
RMBio PurifiedWater 0

Detectability

3001795
DenaturedDehydratedAlcohol
Sasol (SDA3c) 1 4 6 3 4 4 4 1 4 6 6 9 1 6 0 1 1 4 4 1 0 1 9 180

Detectability 1 1 2 1 1 3 3 2 2 2 3 3 2 1 1 3 3 3 2 2 1 2 3

3001761
Shin-Etsu Hypermellose2910(6cPs) 1 1 2 1 1 1 1 9 9 1 1 1 1 1 1 1 6 1 0 6 16 2 1 154

Detectability 1 1 2 2 2 2 2 2 2 2 2 2 2 1 1 2 2 2 1 4 3 2 2

3001763
DewaxedOrangeShellac(Pharma
StroeverGmbH&Co.KG Grade) 9 8 1 4 1 1 1 1 4 6 1 9 4 1 1 1 12 1 6 1 4 4 0 9 9 4 4 216

Detectability 2 2 2 2 2 2 2 2 3 2 2 3 2 1 1 1 1 1 3 1 2 2 1 2 2 2 2

3001744
VertellusSpecialtiesInc. TriethylCitrate 2 4 1 9 1 2 1 6 1 9 1 1 1 1 4 1 4 9 6 0 2 1 12 186

Detectability 1 2 2 2 2 3 2 3 2 3 2 1 1 1 3 2 2 2 2 1 2 2 3
Excipient Risk Assessment:
Features
Easy to learn

Color-coded

Effortlessly implementable with existing processes

 FDA Quality Metrics

Controversial FDA program to better prioritize

audits and reduce drug shortages

Assesses quality based on manufacturing and

quality metrics

Lots Attempted, Lots Rejected, Lot Release Tests, OOS, etc.

Identifies risky manufacturers

 Delay Metrics Project

Data mined and compiled Deviations, Incidents, and Non-

conformances from June 2016 June 2017

Performed Pareto analysis on data

Drilled into data to find trends and recurring events

Performed Human Error analysis

Researched process improvement

Provided suggestions for improvement for the top 80% or Root Causes
 Accounting Visitation

Assisted in month-end activities

Learned about SAP accounting applications

Improved knowledge base of mid-sized accounting

operations
 What I Learned

Industry jargon, conventions, and processes

Assessing risk can be as simple or as complicated as you want it to be.

The complications of human error

How to organize and review large amounts of data

Delivery delays can occur due to cascading errors

The importance of accurate and consistent document management

Suggestions for Improvement

More structure to the intern program

Opportunities for independent study and research

Goal-setting at the beginning of the summer

Set due-dates
Thank You!
Marketing Internship

Danielle
LeBleu
 About me

Junior at Hillsdale College (Hillsdale, MI)

Major: Economics and Applied Mathematics

Prior Experience:

Swim Instructor at Dynamo Swim Club (Hillsdale)

College Swimmer

Nationally ranked in 1650,1000,500 freestyle

 Projects

SCORR/Recro Marketing

Delay Metrics

Department Shadowing
 SCORR Marketing
Work closely with SCORR on brand optimization

Communication between Business Development and SCORR

Website development

Trade show preparation

Brochure development

Digital Ad development

Cost-tracking and budgeting

Recommendations and guidelines for digital media

Content Calendar
 Delay Metrics
Looked at over 900 deviations, non-conformances and

incidents from June 2016-2017 to determine most common

root causes

Top 3 were out-of-trend no investigation, employee error and supplier

error/material issue

Top 3 made up 46% of all reports

Written report detailing findings and recommendations

 Root Cause Pareto Chart
180 120

160
100
140

120 80
Root Cause Counts

Cumulative %
100
60
80 Root Cause Counts
Cumulative %

60 40

40
20
20

0 0
Out-of-trend no investigation; no root cause identified; result confirmed; result not confirmed

Root Causes
 Department Shadowing
Spent a day with numerous different departments to get

understanding of the way everything functions and cooperates

QA

PD

QC

Regulatory

Manufacturing
 Takeaway
Deeper understanding of brand development & marketing

within a heavily regulated industry.

Importance of individual departments and how they contribute

to the effectiveness of the company.

Generalized view and understanding of the industry at large,

from development to regulation to market.

View of the problems that can occur throughout the production

of product and potential solutions.

 Thoughts and Suggestions
Liked: freedom and ability to work with numerous different

departments and third parties to gain both industry and

business development experience

What could be improved: disorganized and unstructured at

times, leading to inefficiency

Suggestion: Weekly meeting with supervisor to touch base on

ongoing projects, occasional performance review

Thank You!

pareto
Materials Management
Internship

Brandon
Harris
 Introduction
25 years old
Duluth, GA
Kennesaw State University
B.S Systems and Industrial Engineering (May 2018)

Hobbies:
Music

Soccer

Laughing
 Projects
Use a Sourcing Methodology to ensure
savings by bidding new/current janitorial
services.
EXCEL Capacity Analysis Model Transfer to
SAP
Custom Plaque Design
Delay Metrics Project
 Janitorial Service Project
Worked with members of Purchasing and
Facilities on bidding new janitorial services for
annual savings.
Supplier Screening of Qualified Janitorial Services
Compiled data from finance to see how much we
have spent with current services
Prepared RFPs/RFIs and sent to prospective
companies.
Capacity Analysis Model to SAP
Worked with Greg, QC, and QA on transferring EXCEL
Capacity Model to SAP
SAP Focused Project
Accomplishments
We can now look at demand on each resource/analyst in the QC

lab based on planned orders

Devised method to view stability and raw material demand in SAP

Ritalin and Focalin recipes and resources have been updated and

tested

Hoping to have Verapamil and Zohydro resources and recipes input

by the end of next week

Production Planning
 Custom Plaque Design
Designed a drawing in Microsoft Paint and sent to
about 15 award companies.
Used sourcing strategies to determine which companies to choose
and proceed with design process

Design idea changed a few times, but was able to

work to an approved final design within budget
Completed Purchase Requisition for Plaques
 Delay Metrics Project
Root Cause Analysis on Production Delays
Data Mining and compiling all reports from
Veeva starting June 2016-June 2017 (~900
reports)
Pareto Analysis on Data
Human Error Analysis
Steps in Production Process
Provided Recommendations for the Top 80% of
Root Causes
 Delay Metrics Project: Root
Causes
Root Causes Root Cause Counts
Out-of-trend no investigation; no root cause
identified; result confirmed; result not
confirmed 160
Employee error 150
Supplier / Vendor / Manufacturer error;
Material Issue; Shipping and Handling 111
Procedure / protocol / specification needs
revision 53
Release 48
Equipment Failure: Non Calibration 47
Combination of factors 41
Equipment failure: Calibration Issue 39
Protocol generation error 33
No issue - tracking for informational purposes 27
 What I Learned
SAP

INCREDIBLE SOFTWARE
Sourcing Methods
Pharmaceutical Production Planning

Ensure manufacturing runs effectively and efficiently and produces

products as required by customers
Pharmaceutical Quality Management

Master Data (Materials, Vendors, Pricing & Conditions, Batch

Management)

cGMP Procedures

Purchase Orders (PO)

Checking, Completing and Verifying invoices in SAP

Materials Management

Use SAP for procurement handling and inventory management

What I Learned about RECRO
Growing and Successful
Team Oriented
Plans are Always Changing
Quality Standards
A company I would love to be a part of!
Benefits of RECRO Internship
Treated with the respect of a regular
employee
Exposure to a new business environment
Able to learn about multiple facets of RECRO
Projects with other interns was great
learning and collaborative experience
More collaboration with interns and other
employees
 Thank You
Questions?

Linkedin.com/in/bkyleharris
bkharris716@gmail.com
AD Internship

Radhika
Sharma
 About Me

Born: Birmingham, Alabama

Raised: Lawrenceville, GA

Alma Mater:

Georgia Institute of Technology

B.S. Biochemistry w/ Concentration in Business

 Background and Overview
API Finished Dosage
Developed a universal Forms

Pharma Industry
analytical skillset
Dissolution Theory
- Chromatography
- Analytical Tests Formulations
- Method - N1540 Lipid-Polymer Hybrid
Development/Transfers Nanoparticles

Innovative process - Characterization using Malvern

chemistry: biocatalysis Zetasizer
experiments
5S Organization of the PD and AD
Yellow-Belt certification labs (previous yellow-belt training)

2 years
2.5 months
 Overview of Meloxicam
Nonsteroidal Anti-Inflammatory Drug (NSAID)

Current Formulation: Intravenous (IV) utilizing Alkermes

NanoCrystal Technology

24 hr pain relief

Process Development Objective:

48 hrs extended release IV formulation of Meloxicam

Onset of 15 min

Help with products lifecycle management

 Lipid Polymer Hybrid
Nanoparticles
Lipid-Polymer Hybrid Nanoparticles (LPNs) have been

scientifically proven as robust drug delivery mechanisms.

High entrapment efficiency Source: Shutterstock

Allows modification of the drug release profile

Source: Daily Mail

High specificity and stability of the LPNs

 Basic Structure of LPNs

Biodegradable
polymer that helps
entrap and release
drug

Envelopes the
PLGA-Drug
Matrix

Source: Gao, et. al.- Royal Society of Chemistry

Surfactant helps
the LPN to
traverse aqueous
mediums
Basic Approach: N1540 LPNs
 Feasibility Studies/DoE
Execution/Demo Batches

Source:
123RF.com

Source: Wired
Main Experimental Parameters
 Challenges
Project itself still consistently demonstrates challenges

Not reproducible

Inconsistent Particle Size

Ranges between 150nm 260nm

Aim: <200 nm

Agglomeration during addition of Meloxicam

Low Entrapment Efficiency

Ranges: 1 20%

Aim: 60% or higher

Occasional crashing out of Meloxicam during concentration (TFF)

 Next Steps
Modify Experimental parameters even further

If unsuccessful

Other routes:

Liposomal formulations

Emulsification
Source: Arctic University of Norway

Agent that will help absorption of Meloxicam in aqueous

environments
 Takeaways
Learning how to cope with set backs

Increased knowledge of pharmaceuticals

Acquired new skillsets to help improve scientific capabilities

 Whats Next

Fall 2017: PhD program in Biomolecular Chemistry

 Acknowledgements
Thank you, Recro Gainesville for this fabulous opportunity!

Love the environment

Would definitely recommend this internship program

Thank you Prabhakar, Jigna, and David

Provided the guidance, knowledge/expertise, and experience to

help my future career and graduate school endeavors.

IT Internship

Jin Park
About Me
Junior at University of Georgia
Major: Management Information
Systems (MIS)

Prior Experiences:
Apple

MetroPCS

Leadership Conferences
 IT Help Desk

Different cases everyday

Main task and focus
Over 150 tickets
resolved
 FAQ

Did IT teach you how to fix all these?

Most common?
The hardest?
The easiest?
Projects
Software License Inventory Audit
Active Directory Info Uniformity
Decommissioned Desktop
Inventory
Windows OS Patch
Outlook Security Patch
Active Directory SOP evaluation
Outlook Security Patch
Unable to open attachments

Multiple complaints

Research

Solution
What I Learned
What I Liked

No Intern treatment
Not a Live in my cubicle job
Non-repetitive work
Continuance learning
Interaction with technology
Meeting, and helping different
departments
Suggestions

Mentorship Program
Map
Laptops
Projects with other
employees or interns
Thank you for the great
experience.