Pharma Conference 2020

March 10-11, 2020

The 2020 Pharma Conference offers two days of information sharing, topical discussions, and networking with pharma professionals. In addition to the general program, attendees can choose between 18 advanced talks delivered in smaller breakout sessions.

Quality | Stability | Method Development/Validation

Contributors include regional subject matter experts, Eastern Carolina ASQ chapter members, and special invited speakers.

Guest Speakers

Geoff Carr

Director, Analytical Development, Ontario

Patheon, by Thermo Fisher Scientific

Forced Degradation and Stability
Workshop Instructor: Setting Up Effective
Stability Programs

Michael Dong

MWD Consulting, Norwalk, CT

HPLC Method Development & Validation
Author: HPLC and UHPLC for Practicing
Scientists, 2nd Ed., Wiley 2019

Jane Weitzel

Independent Consultant

Analytical QbD

Author: HPLC and UHPLC for Practicing
Scientists, 2nd Ed., Wiley 2019

DAY 1

Event Locations: 3rd Floor of the ECU Science and Technology Building

LocationTimeEventDescription
Atrium8:30am - 8:50amCheck-InCoffee, Doughnuts
Room C3098:50am - 9:05amWelcome, Opening RemarksJack Pender, ECU Chemistry Pharm Ctr
Room C3099:05am - 9:50amDrug Development Process from Discovery to MarketWael Elmasri, Thermo Fisher Scientific
Room C30910:00am - 10:45amIt's Not Working! What Will Work? The Lifecycle Approach for MethodsJane Weitzel, Independent Consultant
Atrium10:45am - 11:15amMorning BreakLight snacks, Conversation

Breakout Session 1

LocationTimeEventPresented/Sponsored by
Room 43011:15am - 12:00pmStability - Stability Programs 101Boyce Johnson, Mayne Pharma
Room C30911:15am - 12:00pmMethod Development/Validation - HPLC Method Development Part 1: Overview, Traditional Approaches and ToolsMichael Dong, MWD Consulting
Room 44011:15am - 12:00pmQuality - Quality Management System ReviewJohn Suedback, Merck
Atrium12:00pm - 12:50pmLunchCatered, Olive Garden

Breakout Session 2

LocationTimeEventPresented/Sponsored by
Room 4301:00pm - 1:45pmStability - Stability Study Design of Clinical DevelopmentGeoff Carr, Patheon by Thermo Fisher Scientific (Ontario)
Room C3091:00pm - 1:45pmMethod Development/Validation - HPLC Method Development Part 2: Easier Approaches for Early-Phase MethodsMichael Dong, MWD Consulting
Room 4401:00pm - 1:45pmQuality - "Know Thy Data" Statistical Techniques for Analyzing DataTammy Triplett, Mayne Pharma

Breakout Session 3

LocationTimeEventPresented/Sponsored by
Room 4302:00pm - 2:45pmStability - Adulterated to Misbranded - When Stability gets a Warning LabelJennifer Alligood, CMP Pharma
Room C3092:00pm - 2:45pmMethod Development/Validation - Analytical Quality by Design: aQbD for Analytical MethodsJane Weitzel, Independent Consultant
Room 4402:00pm - 2:45pmQuality - ASQ Programs, Certifications, and Your Local ChapterJohn Suedbeck, ASQ Chapter 1126
Atrium2:45pm - 3:45pmSpecial Afternoon Break - Social HourDistek
Room C3093:45pm - 4:30pmTest Methods in Common: An "Analytical Formulator's" ProspectiveMichael DeHart, CMP Pharma
4:30pm - UntilOptional Gathering Uptown Greenville

Day 2

Event Locations: 3rd Floor of the ECU Science and Technology Building

LocationTimeEventDescription
Atrium8:30am - 9:00amMorning WelcomeCoffee, Bagels
Room C3099:00am - 9:45amQuality Standard Setting Process - A Perspective of USP's RoleAlan Potts, Thermo Fisher Scientific
Room C30910:00am - 10:45amBiopharmaceuticals - An Overview of Process Manufacturing and Analytical TestingJanet Davis, Thermo Fisher Scientific
Atrium10:45am - 11:15amMorning BreakLight snacks, Conversation

Breakout Session 4

LocationTimeEventPresented/Sponsored by
Room 43011:15am - 12:00pmStability - Stability Data Evaluation and
Shelf-life Projection		Craig Hamilton, H&A Scientific
Room C30911:15am - 12:00pmMethod Development/Validation - Forced Degradation StudiesGeoff Carr, Patheon by Thermo Fisher Scientific (Ontario)
Room 44011:15am - 12:00pmQuality - Effective Root Cause AnalysisTammy Triplett, Mayne Pharma
Atrium12:00pm - 12:50pmLunchCatered, GK Café

Breakout Session 5

LocationTimeEventPresented/Sponsored by
Room 4301:00pm - 1:45pmStability - Special Purpose StudiesVonda Sheppard, Mayne Pharma
Room C3091:00pm - 1:45pmMethod Development/Validation - HPLC Method Validation: Overview, Methodologies, and Case StudiesMichael Dong, MWD Consulting
Room 4401:00pm - 1:45pmQuality - Corrective and Preventable ActionsJerry Zemble, Purdue Pharma

Breakout Session 6

LocationTimeEventPresented/Sponsored by
Room 4302:00pm - 2:45pmStability - Packaging Configuration and
Product Type Impact on Stability Testing Requirements		Kristi Pittman, Fresenius Kabi
Room C3092:00pm - 2:45pmMethod Development/Validation - Uncertainty and Statistics for Method ValidationJane Weitzel, Independent Consultant
Room 4402:00pm - 2:45pmQuality - Sampling Types and Plans Used in the Pharmaceutical IndustryDan Carlson, ASQ Chapter 1126
Atrium2:45pm - 3:15pmAfternoon Break & Raffle
Room C3093:15pm - 4:00pmWhat's Hot? A Survey of Recent Warning LettersAngela Corbin, Thermo Fisher Scientific
Room C3094:00pm - 4:30pmDiscussion and Conference Wrap UpJack Pender, ECU Chemistry Pharm Ctr

Thank you to our Program Sponsors!

Gold Sponsor

North Carolina Biotechnology Center

General Sponsor

ThermoFisher Scientific
H&A Scientific
Waters: The Science of What's Possible
ASQ Eastern Carolina 1126
Distek
Investigator

Vendors

  • Agilent Technologies
  • ASQ Eastern Carolina 1126
  • Distek
  • H & A Scientific
  • Instigator, Inc.
  • Mettler Toledo
  • Phenomenex
  • Precision Stability Storage
  • North Carolina Pharmaceutical Services Network
  • TA Instruments
  • Teledyne Hanson
  • Thermo Fisher Scientific
  • Waters

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