I recently had the honour to be invited to speak at the PDA India’s annual conference in Hyderabad. The event was well supported by the local India office of FDA in person and senior FDA personnel (including Carmela Rosa and Jose Melendez amongst others) virtually. It was great to see the FDA continue to support […]
From September 18 to 20, 2024, I was pleased to attend the PDA India Chapter conference on Quality Management Maturity and Supply Chain Resiliency, and I was impressed with the number of people who took three days out of (what must be) busy schedules and demanding jobs in the Indian pharmaceutical industry to attend. […]
The FDA Quality Management Maturity (QMM) program has generated an increased interest in quality culture in the pharmaceutical industry. The Center for Drug Evaluation and Research (CDER) has established a program to encourage manufacturers of drugs (including biologics), with the stated purpose of implementing QMM programs to: Foster a strong quality culture mindset; Recognize establishments […]
What do a cup of cappuccino and sterile water for injection have in common? At first glance, there is no apparent correlation, except when you become “data curious” and take the macro view of the current convergence of economics, compliance, and maturation of risk management. Sometimes utilizing existing data is the best way to understand […]
