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Thank you to the program committee, speakers, attendees and all those involved for a successful 2023 ISPE Aseptic Conference! See you next year in Vienna, Austria!
503B Compounding Pharmacies: Principles, GMPs and Case Studies
Join us on 6 May 2021 for the FREE live webinar "503B Compounding Pharmacies: Principles, GMPs, and Case Studies" to take an in-depth look at how this field has developed since section 503B was created as part of the drug quality and security act in 2013.
Subject matter experts representing Nephron Pharmaceuticals, Vetter Pharma, Fresenius-Kabi, and Lachman Consultants Services will share critical information and first-hand insights you can't get anywhere else as you explore:
- FDA Compounding Laws and Policies
- Food and Drug Cosmetic Act 503A and 503B
- FDA policies on Compounding and other related activities
- FDA Compounding Documents and Actions
- Compounding Inspections Frequently Asked Questions
- Basic GMPs for Sterile Products
- Regulations for aseptic manufacturing for sterile products
- Compounding, filtration, filling, inspection, packaging
- Sterilization methods
- Personnel and training
- Premises, cleanrooms, barrier systems
- Nephron: An Engineering and Production Perspective
- Case Study: Fresenius-Kabi Compounding: A QA Perspective
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