Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing – D2 – Part 2

This symposium, held every two years, explored topics related to pharmaceutical quality regulation, supply chains, and advanced manufacturing technologies.

Timestamps

00:08 – Quality Management Maturity

23:14 – Drug Quality Sampling and Testing

37:23 – CDER Site Selection Model

46:40 – Q&A Discussion Panel

Speakers:

Nandini Rakala, PhD, MS
Visiting Associate & Data Scientist
Office of Quality Surveillance (OQS)
Office of Pharmaceutical Quality (OPQ) | CDER

Stephen Cahill, MBA
Operations Research Analyst
OQS | OPQ | CDER

John Wan, MBA
Supervisory Operations Research
OQS | OPQ | CDER

Panelists:

Nandini Rakala, Stephen Cahill, John Wan,

and

Wendy Wilson, PhD
Deputy Office Director
OQS | OPQ | CDER

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Phone - [phone] I [phone]