ECU Spring Break 2019 Pharma Conference

Attendees will participate in lectures and discussions led by regional experts covering an array of topics fundamental to working in the pharmaceutical industry at this two-day conference. 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.

This event is suitable for pharmaceutical professionals with up to 5 years experience and those who have a desire to know more about the pharmaceutical industry and regulations.

Topics and Speakers

Introduction to the Pharmaceutical Industry; History and Laws
Keith Holmes, ECU Chemistry, Pharma Center

Drug Development Process
Wael Elmasri, Thermo Fisher

Quality Systems
Angela Swain, Thermo Fisher

Electronic Records, Part 11, and Data Integrity
Stacy Southerland, Thermo Fisher

Stability Programs
Boyce Johnson, Mayne Pharma

The USP Organization and Compendia Testing
Alan Potts and Martina Jones, Thermo Fisher

Introduction to Validation
Jennifer Popovich, Mayne Pharma

The Purpose of Common Pharma Test Methods
Michael Dehart, CMP Pharma

Analytical Methods Validation, Transfer, System Suitability
Richard Vinson, Mayne Pharma

Introduction to Regulatory Filings
Kimberly Lupo, Mayne Pharma

Survey of Recent Warning Letters
Angela Swain, Thermo Fisher

Finding Guidance….CFR, FDA, ICH, USP, PF, and Other Resources
Jack Pender, ECU Che mistry, Pharma Center