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Application Of Lean Six Sigma To Reduce The Cost Of Regulatory Noncompliance., Reham Nour, Chad Laux Jun 2021

Application Of Lean Six Sigma To Reduce The Cost Of Regulatory Noncompliance., Reham Nour, Chad Laux

International Conference on Lean Six Sigma

1. Purpose

This research focused on the adoption of Six Sigma within FDA-regulated pharmaceutical companies to create an effective CAPA system for reducing the cost of noncompliance and supporting organizational performance.

2. Design/Methodology/Approach

This study utilized the DMAIC methodology, in a case study, to improve the CAPA process within a medical device company regulated by the FDA. All the critical requirements for compliance CAPA system was being defined from the FDA sources and the DMAIC model was be applied to improve and maintain CAPA performance.

3. Findings

Using the DMAIC approach supported identifying the bottlenecks and process variation. within CAPA. …


A Comparison Of Student Pharmacist Clinical Interventions During An Internal Medicine Advanced Pharmacy Practice Experience (Appe) In A High-Income Versus Low-Income Setting, Ellen Schellhase, Monica Miller, Shelby Wilkinson, Rakhi Karwa Dec 2018

A Comparison Of Student Pharmacist Clinical Interventions During An Internal Medicine Advanced Pharmacy Practice Experience (Appe) In A High-Income Versus Low-Income Setting, Ellen Schellhase, Monica Miller, Shelby Wilkinson, Rakhi Karwa

Engagement & Service-Learning Summit

Objectives: Compare and contrast the number and type of interventions made by student pharmacists who participated in an adult internal medicine APPE in the US to an internal medicine APPE in Kenya.

Methods: A US-based faculty-led, four-week internal medicine APPE with interprofessional team rounding that provides care for underserved patients in an urban setting and hosts 16 students annually was compared to a faculty-led, eight-week internal medicine APPE in Kenya that hosts on average 24 students annually. Starting May 2017 – January 2018 a standard clinical intervention collection form was used by all students on these two APPEs starting …


Targeting Neuropeptides To Bone Fractures For Accelerated Healing, Nicholas A. Young, Jeffery J. Nielsen, Philip S. Low Aug 2018

Targeting Neuropeptides To Bone Fractures For Accelerated Healing, Nicholas A. Young, Jeffery J. Nielsen, Philip S. Low

The Summer Undergraduate Research Fellowship (SURF) Symposium

In patients over the age of 65 especially, bone fractures represent a significant disease burden. Non-invasive drug therapies are not available for bone fractures which represents a problem for this population. Vasoactive intestinal peptide (VIP) and Pituitary Adenylate Cyclase-Activating Polypeptide (PACAP), two neuromodulator peptides in the glucagon superfamily, have demonstrated positive regulation of osteoblast proliferation and activity. Using acidic oligopeptides, we have developed ligands that target to and accumulate at fracture sites. These targeting ligands can be synthesized in sequence with bone anabolic peptides to minimize off target effects and increase potency at the fracture site to create safer and …


Pharmacy Practice And Research: The Development Of A University Collaboration In Colombia, Ellen Schellhase Jan 2018

Pharmacy Practice And Research: The Development Of A University Collaboration In Colombia, Ellen Schellhase

Engagement & Service-Learning Summit

No abstract provided.


Safety And Service-Learning: Engaging Pharmacy Students To Make Safer Communities, Patricia Darbishire, Chelsea Anderson Jan 2018

Safety And Service-Learning: Engaging Pharmacy Students To Make Safer Communities, Patricia Darbishire, Chelsea Anderson

Engagement & Service-Learning Summit

Poster Abstract

Objective:

To evaluate student perceptions of a service-learning experience for potential implementation in the curriculum.

Method:

A new 3-week intensive elective course was piloted in the Spring of 2017 at Purdue University College of Pharmacy. Seven third professional year students were included in the pilot and were divided into three groups. Each group of 2-3 students was assigned to one of 3 predetermined community partner sites. Students were taught how to perform a needs assessment and then designed a project targeted to improve safety at their site. Students completed a pre-post questionnaire that assessed their perceptions of the …


Expansion Of Pharmacy Students’ Involvement In Global Health And International Clinical Rotations, Alice C. Chang, Monica L. Miller, Ellen M. Schellhase Jan 2018

Expansion Of Pharmacy Students’ Involvement In Global Health And International Clinical Rotations, Alice C. Chang, Monica L. Miller, Ellen M. Schellhase

Engagement & Service-Learning Summit

No abstract provided.


Finding Human Proteins That Bind To A Lassa Virus Protein, Maria Alejandra Pardo Ruge, Veronica J. Heintz, Douglas J. Lacount Aug 2017

Finding Human Proteins That Bind To A Lassa Virus Protein, Maria Alejandra Pardo Ruge, Veronica J. Heintz, Douglas J. Lacount

The Summer Undergraduate Research Fellowship (SURF) Symposium

Viral hemorrhagic fevers are severe illnesses caused by many different viruses. Lassa Virus is one of these important pathogens in Western Africa, causing hemorrhagic fever and eventually death without early medical treatment. There is no vaccine and there is little information on host-pathogen interactions. Therefore, the interaction between viral proteins and host targets is useful to understand Lassa virus’s lifecycle and pathology, and to develop ways to prevent infection. In this project, we study the nucleoprotein of Lassa virus (NP), which has been reported to have anti-interferon (IFN) activity through elimination of double stranded RNA (dsRNA). These features could be …


Pharmacy Research On Medication Disposal Practices Using Service-Learning, Patricia L. Darbishire, Anne Packard, Maryam Noureldin, Sumaya Bahrami Mar 2016

Pharmacy Research On Medication Disposal Practices Using Service-Learning, Patricia L. Darbishire, Anne Packard, Maryam Noureldin, Sumaya Bahrami

Engagement & Service-Learning Summit

Abstract

The purpose was to engage students in local communities to determine what types of medications commonly go unused, discover common medication disposal practices, gauge the public’s opinion on medication disposal, and collect unwanted medications.

Student pharmacists and a faculty mentor hosted 15 medication take-back events in conjunction with community partners, and administered a survey to participants exploring disposal practices, opinions and returned medication(s). Educational brochures on safe disposal methods were distributed to participants.

Four hundred and seventy-eight surveys were collected and 4,993 medications were identified and analyzed. The top three reasons for bringing medications to collection events included: medication …


Student And Community Perceptions On Reasons For Medication Non-Adherence, Patricia L. Darbishire, Daraoun Mashrah Mar 2016

Student And Community Perceptions On Reasons For Medication Non-Adherence, Patricia L. Darbishire, Daraoun Mashrah

Engagement & Service-Learning Summit

Abstract

The purpose of this research was to improve medication adherence by exploring and reflecting on differences in the perceptions of pharmacy students and the public regarding factors contributing to medication non-adherence.

Two hundred eighty six pharmacy students and 310 patients participated in this study. Patients were recruited by pharmacy students from Midwest community pharmacies, while the students completed an experiential rotation. Students identified their patients based on evidence of non-adherence from medication profiles and asked patients to participate in the assignment. Data was collected over a four-year period, resulting in two years of information on patient perceptions and two …


Development Of A Pharmacy Service-Learning Course About Vulnerable And Underserved Patient Care, Josephine P. Aranda, Jeffrey D. Luke, Kimberly S. Plake Mar 2016

Development Of A Pharmacy Service-Learning Course About Vulnerable And Underserved Patient Care, Josephine P. Aranda, Jeffrey D. Luke, Kimberly S. Plake

Engagement & Service-Learning Summit

No abstract provided.


Drug Abuse/Addiction Education (Phrm 316): A Service-Learning Course, Elizabeth J. Dowell, Ashley M. Schinker, Jane E. Krause, Richard M. Van Rijn, Val J. Watts Mar 2016

Drug Abuse/Addiction Education (Phrm 316): A Service-Learning Course, Elizabeth J. Dowell, Ashley M. Schinker, Jane E. Krause, Richard M. Van Rijn, Val J. Watts

Engagement & Service-Learning Summit

No abstract provided.


Fluorescein Dye For Exploring Anti-Cancer Drug Dissolution Kinetics, Connor Davis, Tonglei Li, Wei Gao Aug 2015

Fluorescein Dye For Exploring Anti-Cancer Drug Dissolution Kinetics, Connor Davis, Tonglei Li, Wei Gao

The Summer Undergraduate Research Fellowship (SURF) Symposium

Nanocrystalline formulations of anti-tumor drugs have been shown to improve desirable characteristics as well as increase the efficacy of delivery. However, the improvements seen are not strong enough to eradicate tumors and there exists a need to better understand how the drug particles move about and release in the body. The use of fluorophores incorporated into substrates allows for highly sensitive and resolute imaging in the body without the need for radioisotopes. This research aims to utilize quenching characteristics of fluorescein in order to provide pharmacokinetic information to aid in the improvement of nanoparticulate delivery formulations. Nanocrystal formulations of paclitaxel …


Effect Of Twin Screw Granulator Process Parameters On Granule Attributes, Haosheng Xu, Ridade Sayin, James Litster Aug 2014

Effect Of Twin Screw Granulator Process Parameters On Granule Attributes, Haosheng Xu, Ridade Sayin, James Litster

The Summer Undergraduate Research Fellowship (SURF) Symposium

Twin screw wet granulation has been considered as an efficient and effective technique of manufacturing granules (agglomerates made up of small particles) and has been widely applied in pharmaceutical industry. However, narrow granule size distributions are difficult to achieve. This study aims to elucidate the effect of process parameters such as liquid feed rate and screw configuration on the granule attributes through granule characterization. The methods used are sieve analysis (for size distribution), liquid distribution (determining the dye concentration in the granules) and density and porosity (percentage gas volume in the granule) analyses. A sieve shaker is used to divide …


Exploring The Effect Of Solution Speciation On Crystallization Outcome, David M. Harvey, Arjun Kalra, Tonglei Li Aug 2014

Exploring The Effect Of Solution Speciation On Crystallization Outcome, David M. Harvey, Arjun Kalra, Tonglei Li

The Summer Undergraduate Research Fellowship (SURF) Symposium

In the field of pharmaceuticals, the crystallization process significantly impacts the purity, morphology and polymorphism of active pharmaceutical ingredients (API), all of which are important in drug development. Polymorphism is the existence of more than one solid-state form of the same chemical entity. Tolfenamic acid (TFA), a Non-Steroid Anti-inflammatory drug (NSAID), has been shown to exhibit a unique physical phenomenon called concomitant polymorphism, whereby two polymorphs crystallize from the solution simultaneously. From previous work, it has been established that solution speciation i.e. the presence of monomers or dimers of TFA in solution is concentration and temperature dependent. This study correlates …


A Service Learning Experience For Pharmacy Students Involving Unwanted Medication Collection, Patricia L. Darbishire Jan 2014

A Service Learning Experience For Pharmacy Students Involving Unwanted Medication Collection, Patricia L. Darbishire

IMPACT Symposium

This poster outlining a serve learning experience of students in Purdue’s pharmacy program was presented at the IMPACT Symposium 2014.


Investigating Intermolecular Interactions In Crystalline Aspirin Using Cdft, Nicholas Turner, Tonglei Li, Mingtao Zhang Oct 2013

Investigating Intermolecular Interactions In Crystalline Aspirin Using Cdft, Nicholas Turner, Tonglei Li, Mingtao Zhang

The Summer Undergraduate Research Fellowship (SURF) Symposium

Drugs today are widely administered in their crystalline form, namely via tablets and capsules. The crystal structure of a drug molecule affects important drug qualities such as solubility, bioavailability, shelf life, and compaction properties. In order to form a basis for crystal structure prediction, it is necessary to first understand how intermolecular interactions cause molecules to pack in certain ways. Being able to predict and perhaps even control a drug molecule’s crystal structure will lead to the development of higher quality drugs that perform more consistently. Scientists and engineers do not fully understand the reasons for a molecule assuming a …


Investigation Of Major Intermolecular Interactions In 7,8-Dihydrobenzo(K)Phenanthridin-6(5h)-One Crystal Using Quantum Calculations And Crystallographic Visualization Programs, Zhiwei Liao, Tonglei Li, Mingtao Zhang Oct 2013

Investigation Of Major Intermolecular Interactions In 7,8-Dihydrobenzo(K)Phenanthridin-6(5h)-One Crystal Using Quantum Calculations And Crystallographic Visualization Programs, Zhiwei Liao, Tonglei Li, Mingtao Zhang

The Summer Undergraduate Research Fellowship (SURF) Symposium

Currently, tablets and capsules are the most common ways of delivering drugs. The active pharmaceutical ingredients and excipients used to make those tablets and capsules are in their crystalline form generally. However, a single molecule can form multiple different crystal structures because of different packing arrangements of the molecules. These different crystal structures have identical chemical composition but different properties such as solubility, density, stability, etc. This phenomenon is called polymorphism. Occurrence of polymorphism could be a disaster for both patients and pharmaceutical companies, as the drug could lose its efficacy due to changes in properties. Studying intermolecular interactions in …


Bigpic: Bridging Income Generation With Provision Of Incentives For Care, Sonak Pastakia Apr 2012

Bigpic: Bridging Income Generation With Provision Of Incentives For Care, Sonak Pastakia

Changing World Conference

No abstract provided.