|
|
|
| New FDA QMSR: Its Role in Part 4 Compliance for Combination Products | The FDA’s release of the new Quality Management System Regulation (QMSR) significantly revises 21 CFR Part 820 Quality System Regulation and, in turn, Part 4 CGMP for combination products. Join us on June 26th as experts discuss the history and intentions of the new QMSR and what it means for combination product manufacturers and areas of risk your organization may need to address. |
|
|
|
|
By Charles L. Mauro, CHFP, and Christopher Morley, MSc., Mauro Usability Science | Drug administration by lay users is becoming more common. Is current FDA guidance viable for demonstrating safe and effective use for critical devices and systems? No. |
|
|
|
|
|
|
|
|
|
|
|
.png){kind=logo}
