A1: Managing Investigations in a Global Network

Monday, September 27, 2021

13:30 – 15:00 EDT

Moderator(s)

Rick Friedman, MS

Deputy Director, OMQ, OC, CDER
U.S. FDA
Silver Spring, Maryland, United States

Panelist(s)

Lisa Newcombe-Dierl

Vice President Corporate Quality
Amgen Inc.
Thousand Oaks, California, United States
Emabelle Ramnarine, PhD

Executive Director, Product Management & Development Operations
Boehringer Ingelheim
Fremont, California, United States

Presenter(s)

Lisa Newcombe-Dierl

Vice President Corporate Quality
Amgen Inc.
Thousand Oaks, California, United States

Presentation Handout
Emabelle Ramnarine, PhD

Executive Director, Product Management & Development Operations
Boehringer Ingelheim
Fremont, California, United States

Regulatory Panelist(s)

VG

Victor (Ray) Gaines

Branch Chief, OMQ, OC, CDER
U.S. FDA
silver spring, Maryland, United States

Today’s global pharmaceutical supply chain typically includes many contributors to production of a drug. Strong quality system provisions and actions are needed when deviations, OOS results, or failures occur to ensure communications and close collaboration on investigations and resolutions. This session will address the attributes of quality systems that successfully manage cross-organizational investigations, with an emphasis on lessons learned and practical case studies.

Presentations:

13:30 – 13:55 EDT

Managing Investigations with Supply Chain Partners Using a QRM Mindset
Presenter: Emabelle Ramnarine, PhD (she/her/hers) – Boehringer Ingelheim
13:55 – 14:21 EDT

Effective CAPA Practices As A Competitive Advantage
Presenter: Lisa Newcombe-Dierl – Amgen Inc.
14:21 – 15:00 EDT

Live Q&A (A1)
Moderator: Rick L. Friedman, MS – U.S. FDA
Panelist: Lisa Newcombe-Dierl – Amgen Inc.
Panelist: Emabelle Ramnarine, PhD (she/her/hers) – Boehringer Ingelheim
Regulatory Panelist: Victor (Ray) Gaines – U.S. FDA