Blood & Blood Products
The Center for Biologics Evaluation and Research (CBER) regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components, such as clotting factors, and establish standards for the products themselves. CBER also regulates related products such as cell separation devices, blood collection containers and HIV screening tests that are used to prepare blood products or to ensure the safety of the blood supply. CBER develops and enforces quality standards, inspects blood establishments and monitors reports of errors, accidents and adverse clinical events.
Featured Products
Best Practices in Quality and Compliance Management
Price: $70.00
Price: $70.00
Making Sense of FDA's (proposed) Rules for the Development and Approval of Biosimilars
Marketing and sale of biosimilars - FDA guidance documents - Reference Biological Product - Clinical Data - biosimilar approval
Marketing and sale of biosimilars - FDA guidance documents - Reference Biological Product - Clinical Data - biosimilar approval
Delivering Biopharmaceutical Facilities in a Risk Based World: The Role of GEP, QbD, and E2500
Applicable regulatory guidelines - manufacturing of Biopharmaceutical APIs - GMP requirements - cell culture/fermentation - cell bank maintenance and recordkeeping
Applicable regulatory guidelines - manufacturing of Biopharmaceutical APIs - GMP requirements - cell culture/fermentation - cell bank maintenance and recordkeeping
Cleaning Validation Regulations for Biopharmaceuticals: Strategies for Compliance
Biopharmaceuticals vs. drugs - Cleaning assessment and monitoring - Strategies for efficient cleaning validation - Risk assessment - ICH guidelines
Biopharmaceuticals vs. drugs - Cleaning assessment and monitoring - Strategies for efficient cleaning validation - Risk assessment - ICH guidelines
