Tuesday, June 25 • 4:15pm - 5:30pm
#297: Integration of Manufacturing Quality Assessment and Pre-Approval Inspections

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-642-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss various case studies that illustrate the mechanism for risk-based holistic assessment of pharmaceutical manufacturing, and how such assessment leads to a thorough and timely assessment.

Learning Objectives

Describe the benefits of holistic pharmaceutical manufacturing assessment that involves closer alliance between drug product quality assessment and facility inspection; Recognize manufacturing risks that act as triggers for pre approval inspections.


Joanne Wang, PhD


Integrated CMC Review and Inspection for a Combination Product: A Case Study
Nikolas Burlew

Proposal to Improve Risk-Based Regulatory Application Assessment
Roger Nosal, PhD

Regulatory Considerations for Manufacturing Assessment and Pre-Approval Inspections
Derek Smith, PhD

avatar for Nikolas Burlew

Nikolas Burlew

Executive VP, RSD Global Consulting, Clinipace
Nik is a pharmaceutical professional with over twenty-seven years of experience in Drug Development, Manufacturing and Quality Assurance. He leads the Regulatory and Strategic Development Global Consulting group within Clinipace, Inc. which is focused on advancing drug and biologic... Read More →
avatar for Roger Nosal

Roger Nosal

Vice President, Global CMC, Pfizer Inc
Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several PhRMA, ICH, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees... Read More →
avatar for Derek Smith

Derek Smith

Director, Div of Inspectional Assessment, OPF, OPQ, CDER, FDA
Derek Smith is the Director of the Division of Inspectional Assessment and the Acting Associate Director for Regulatory Affairs in the Office of Process and Facilities where he oversees the assessment of the manufacturing process and facilities for biologics and small molecule drug... Read More →
avatar for Joanne Wang

Joanne Wang

Acting Quality Assessment Lead, OPF, OPQ, CDER, FDA
Dr. Joanne Wang joined FDA in 2015 as a chemical engineer with expertise in drug delivery from complex devices, systems modeling, and in vivo superresolution imaging. She is currently the Acting Quality Assessment Lead in Branch IV, Division II of Office of Process and Facilities... Read More →

Tuesday June 25, 2019 4:15pm - 5:30pm
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA