Webcast | Virtual
Event Title
A Pharmaceutical Quality Webinar for Global Stakeholders
July 23, 2020
- Date:
- July 23, 2020
| Title | Presenter |
|---|---|
| Pharmaceutical Quality: A Global Priority | Patrizia Cavazzoni, MD Deputy Center Director for Operations CDER | FDA |
| An International Commitment to Pharmaceutical Quality | Michael Kopcha, PhD, RPh Director 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 Director 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 OQS | OPQ | CDER | FDA |
| Successfully Implementing Advanced Manufacturing |
Sau (Larry) Lee Director Office of Testing and Research (OTR) | OPQ | CDER | FDA |
| Panel Questions and Discussion |
Christopher Middendorf Raphael Brykman Sau (Larry) Lee |
ABOUT
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.
INTENDED AUDIENCE
- Foreign manufacturing professionals (drug product and API)
- Foreign regulators
- Regulatory affairs professionals (innovator and generic or biosimilar)
FDA RESOURCES
- Regulatory Education for Industry (REdI): 2019 Pharmaceutical Quality Symposium
- FDA’s Office of Pharmaceutical Quality
- OPQ Annual Report, 2019
- Report on the State of Pharmaceutical Quality, 2018
- Pharmaceutical Quality Resources