Pharma Conference 2019
March 5-6, 2019
Back to Basics: The Pharmaceutical Industry
During this 2-day course, attendees will participate in lectures and discussions led by regional experts covering an array of topics fundamental to working in the pharmaceutical industry. The presentations are intended to supplement the practical knowledge working professionals use daily with a broader understanding of the pharmaceutical industry and the regulations that govern it. In addition to the formal program, attendees will have substantial time for discussions with experts and peers during breaks, meals, and social times.
Beverages, lunch, snacks, lecture slides, and supplemental materials will be provided.
DAY 1
Event Locations: 3rd floor of the ECU Science and Technology Building, Room 346.
| Time | Topic | Presenter |
|---|---|---|
| 8:30am - 8:50am | Check in; coffee, doughnuts, conversation | |
| 8:50am - 9:05am | Welcome, Opening Remarks | Jack Pender, ECU Chemistry, Pharma Center |
| 9:05am - 9:50am | Introduction to the Pharmaceutical Industry; History and Law | Keith Holmes, ECU Chemistry, Pharma Center |
| 10:00am - 10:45am | Drug Development Process | Wael Elmasri, Thermo Fisher Scientific |
| 10:45am - 11:15am | Morning Break; light snacks, conversation | |
| 11:15am - 12:00pm | Quality Systems | Angela Swain, Thermo Fisher Scientific |
| 12:00pm - 12:50pm | Lunch; Catered, conversation | |
| 1:00pm - 1:50pm | Electronic Records, Part 11, and Data Integrity | Stacy Southerland, Thermo Fisher Scientific |
| 2:00pm - 2:50pm | Stability Programs | Boyce Johnson, Mayne Pharma |
| 2:50pm - 3:15pm | Afternoon Break; light snacks, conversation | |
| 3:15pm - 4:15pm | The USP Organization and Compendia Testing | Alan Potts and Martina Jones, Thermo Fisher Scientific |
| 4:15pm - 5:00pm | Social Hour, End of Day 1 |
DAY 2
Event Locations: 3rd floor of the ECU Science and Technology Building, Room 346.
| Time | Topic | Presenter |
|---|---|---|
| 8:30am - 8:50am | Coffee, doughnuts, conversation | |
| 9:00am - 9:50am | Introduction to Validation | Jennifer Popovich, Mayne Pharma |
| 10:00am - 10:45am | The Purpose of Common Pharma Test Methods | Michael Dehart, CMP Pharma |
| 10:45am - 11:15am | Morning break; light snacks, conversation | |
| 11:15am - 12:00pm | Analytical Method Validation, Transfer, System Suitability | Richard Vinson, Mayne Pharma |
| 12:00pm - 12:50pm | Lunch; Catered, conversation | |
| 1:00pm - 1:50pm | Introduction to Regulatory Filings | Kimberly Lupo, Mayne Pharma |
| 2:00pm - 2:50pm | Survey of Recent Warning Letters | Angela Swain, Thermo Fisher Scientific |
| 2:50pm - 3:15pm | Afternoon Break; light snacks, conversation | |
| 3:15pm - 3:45pm | Finding Guidance... CFR, FDA, USP, PF, Conferences, and Other Resources | Jack Pender, ECU Chemistry, Pharma Center |
| 3:45pm - 4:00pm | Conference Wrap-up, Feedback, and Future Events |
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