Pharma Conference 2022

May 10-11, 2022

#ECUpharma

The ECU Spring Pharma Conference offers two days of information sharing, topical discussions, and networking with fellow pharma professionals. Contributors include regional subject matter experts, vendors, and invited speakers.

In addition to the General Program, attendees can choose between 18 targeted presentations delivered in smaller breakout sessions covering:

Pharma Fundamentals

Designed to supplement the practical
knowledge early-career professionals use
daily with a broader understanding of
the pharmaceutical industry and address
the “why” behind common pharma
approaches.

Method Development &
Validation Sessions

Designed to address issues
in MD/MV with emphasis on
understanding the Analytical
Method Lifecycle Approach.

Quality Sessions

Designed for Quality and
Advanced Laboratory
Professionals to discuss current
trends and best practices in
pharma quality.

DAY 1

Event Locations: 1st Floor of the ECU Life Sciences and Biotechnology Building

Location	Time	Event	Description
Lobby	8:00am - 8:30am	Check-In	Coffee, Doughnuts
Room 1006	8:30am - 8:45am	Day 1 Welcome	Jack Pender, ECU ERPC
Room 1006	8:45am - 9:30am	The Lab Analyst's Role	Michael DeHart, CMP Pharma
Lobby	9:30am - 10:00am	Networking Break	Light snacks, Conversation
Room 1006	10:00am - 10:45am	Advancing Modeling from Highly Accelerated Stability Testing (ASAP) to Determine Drug Product Stability	Kenneth C. Waterman, FreeThink Technologies (virtual)
Room 1006	10:45am - 11:00am	Break

Breakout Session 1

Location	Time	Event	Presented/Sponsored by
Room 3002	11:00am - 11:45am	Pharma Fundamentals - The Drug Development Process	Wael Elmasri, Thermo Fisher Scientific
Room 1006	11:00am - 11:45am	Method Development & Validation - USP Analytical Procedure Lifecycle	Lucy Botros, Thermo Fisher Scientific
Room 1001	11:00am - 11:45am	Quality - Why is Electronic CDS Data a Major Data Concern for Regulators?	Emily Cluggish, Waters Corporation
Room 1006	11:45am - 1:00pm	Lunch	Sequence, Inc.

Breakout Session 2

Location	Time	Event	Presented/Sponsored by
Room 3002	1:00pm - 1:45pm	Pharma Fundamentals - What makes a Lab GMP?	Kimberely Lupo, Portrett Pharmaceuticals
Room 1006	1:00pm - 1:45pm	Method Development & Validation - Comments and Insights on Draft ICH Q2 (Rev2)	Pierre Lebrun, PharmaLex
Room 1001	1:00pm - 1:45pm	Quality - Quality During a Global Pandemic	Wendy Haines, PharmEng Technologies Inc.

Breakout Session 3

Location	Time	Event	Presented/Sponsored by
Room 3002	2:00pm - 2:45pm	Pharma Fundamentals - Stability Programs 101	John Glennon, Novo Nordisk
Room 1006	2:00pm - 2:45pm	Method Development & Validation - Understanding the Relationship between Total Error and Measurement Uncertainty	Pierre Labrun, PharmaLex
Room 1001	2:00pm - 2:45pm	Quality - What will change with the new Computer Software Assurance Guidance document?	Joseph Franchetti, JAF Consulting Inc
Lobby	2:45pm - 3:15pm	Networking Break
Room 1006	3:15pm - 4:00pm	Reflections on a Pharma Career	Tom Wilson, Retired
Room 4007	4:00pm - 6:00pm	Welcome Reception	CMP Pharma

Day 2

Event Locations: 1st Floor of the ECU Life Sciences and Biotechnology Building

Location	Time	Event	Description
Lobby	8:00am - 8:30am	Check-In	Coffee, Doughnuts
Room 1006	8:30am - 8:45am	Day 2 Welcome	Jack Pender, ECU ERPC
Room 1006	8:45am - 9:30am	Inside the USP: General Chapter Development and Revision Process	Lucy Botros, Thermo Fisher Scientific
Lobby	9:30am - 10:00am	Networking Break	Light snacks, Conversation
Room 1006	10:00am - 10:45am	Analytical Development within a CDMO - Focus Assay: Capillary Electrophoresis, Sodium Dodecyl Sulfate	Emily Bermes, Thermo Fisher Scientific
Lobby	10:45am - 11:00am	Break

Breakout Session 4

Location	Time	Event	Presented/Sponsored by
Room 3002	11:00am -11:45am	Pharma Fundamentals - Dissolution Fundamentals	Ken Boda, Agilent Technologies
Room 1006	11:00am - 11:45am	Method Development & Validation - Choosing an HPLC column. Phases explained	Ali Khorasani, Phenomenex
Room 1001	11:00am - 11:45am	Quality - Quality 4.0 Future of Quality Technologies and Innovation	Amy Taylor, Novo Nordisk
Room 1006	11:45am - 1:00pm	Lunch

Breakout Session 5

Location	Time	Event	Presented/Sponsored by
Room 3002	1:00pm - 1:45pm	Pharma Fundamentals - What is Data Integrity?	Ryan Edgerton, Thermo Fisher Scientific
Room 1006	1:00pm - 1:45pm	Method Development & Validation - Analytical QbD Practices with FUSION in Method Development	Zhimin Liu, Thermo Fisher Scientific
Room 1001	1:00pm -1:45pm	Quality - How Project Management and Project Planning Contribute to Quality in an Organization	Jason Baird, PharmEng Technology Inc

Breakout Session 6

Location	Time	Event	Presented/Sponsored by
Room 3002	2:00pm - 2:45pm	Pharma Fundamentals - Understanding HPLC System Suitability: Arts and Crafts Session	Jack Pender, ECU ERPC
Room 1006	2:00pm - 2:45pm	Method Development & Validation - Analytical QbD and Draft ICH Q14: Analytical Procedure Development	Pierre Lebrun, PharmaLex
Room 1001	2:00pm - 2:45pm	Quality - Regulatory Expectations for Laboratory Invesitgations	Amy Taylor, Novo Nordisk
Lobby	2:45pm - 3:15pm	Network Break & Vendor Raffle
Room 1006	3:15pm - 4:00pm	Survey of Recent Warning Letters	Joseph Franchetti, JAF Consulting Inc.
Room 1006	4:00pm - 4:30pm	Conference Wrap Up	Jack Pender, ECU ERPC