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  4. A Pharmaceutical Quality Webinar for Global Stakeholders - 07/23/2020 - 07/23/2020
  1. News & Events for Human Drugs


Event Title
A Pharmaceutical Quality Webinar for Global Stakeholders
July 23, 2020

July 23, 2020
9:00 AM - 5:00 PM ET

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Title Presenter
Pharmaceutical Quality: A Global Priority Patrizia Cavazzoni, MD
Deputy Center Director for Operations
An International Commitment to Pharmaceutical Quality Michael Kopcha, PhD, RPh
Office of Pharmaceutical Quality (OPQ) | CDER | FDA
Manufacturing Assessment and Application Action Rakhi Shah
Office of Pharmaceutical Manufacturing Assessment (OPMA) | OPQ | CDER | FDA
Pre-Approval Inspections and Use of Alternative Approaches to Facility Assessment Derek Smith & Mahesh Ramanadham
Office of Pharmaceutical Manufacturing Assessment (OPMA) | OPQ | CDER | FDA
Pre-License Inspections and Aseptic Processing Zhihao Peter Qiu
Office of Pharmaceutical Manufacturing Assessment (OPMA) | OPQ | CDER | FDA
Panel Discussion

Rakhi Shah

Mahesh Ramanadham

Derek Smith

Zhihao Peter Qiu

FDA’s International Mission and the Global Manufacturing Landscape

Lane Christensen

Assistant Country Director

US FDA China Office

Quality Management Maturity: FDA Vision & Expectations

Alex Viehmann

Office of Quality Surveillance (OQS) | OPQ | CDER | FDA

Major Issues and Facilities in Drug Master Files

Wei Liu

Office of New Drug Products (ONDP) | OPQ | CDER | FDA

Pharmaceutical Quality Policies: What You Need to Know Ashley Boam
Office of Policy for Pharmaceutical Quality (OPPQ) | OPQ | CDER | FDA
Panel Questions and Discussion

Lane Christensen

Alex Viehmann

Wei Liu

Ashley Boam

FDA’s International Office and the Pharmaceutical Quality Mission

Christopher Middendorf

US FDA India Office

The State of Pharmaceutical Quality: Surveillance Findings

Raphael Brykman


Successfully Implementing Advanced Manufacturing

Sau (Larry) Lee


Office of Testing and Research (OTR) | OPQ | CDER | FDA

Panel Questions and Discussion

Christopher Middendorf

Raphael Brykman

Sau (Larry) Lee


In this era of globalization, engaging international stakeholders is essential to furthering the overall commitment to pharmaceutical quality. Events that address developments in pharmaceutical quality exclude many international stakeholders as these events fall well outside their working day due to international time differences. To address this, OPQ and SBIA and the FDA’s India and China offices are hosting a first-of-its-kind, nighttime, online, interactive event to fall within the working day for international stakeholders in India and China. Please join us in furthering the global commitment to pharmaceutical quality.


  • Foreign manufacturing professionals (drug product and API)
  • Foreign regulators
  • Regulatory affairs professionals (innovator and generic or biosimilar)


  1. Regulatory Education for Industry (REdI): 2019 Pharmaceutical Quality Symposium
  2. FDA’s Office of Pharmaceutical Quality
  3. OPQ Annual Report, 2019
  4. Report on the State of Pharmaceutical Quality, 2018
  5. Pharmaceutical Quality Resources
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