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| 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. |
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By Marcelo Trevino, independent expert | The U.K.’s MHRA has updated its transition arrangement dates for CE marked devices with regard to EU MDR compliance. |
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| KinetiSol Technology: Scale Up Approach | Webinar | AustinPx | Process parameter and quality attribute relationships, including those for typical pre and post KinetiSol unit operations, will be explored in the context of real-world examples. |
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