5 courses with the subject BQC, each shown exactly as we captured it from the college's catalog, with every element we hold. Where the wording looks broken, that is our reading of the catalog, not the college's text.
This course presents the importance and underlying principles of QA/AC. Topics include bio-safety, potency, and impurity profile issues for biologic/biopharmaceutical products; setting appropriate and meaningful product specifications and expiration dates; managing manufacturing process changes; identif
This course presents standard for Environmental Health and Safety as it relates to Biotechnology Biopharmaceutical laboratory environments and safety consideration, including personal protective equipment (PPE) and facility safety equipment for typical safety hazard types that may exist or may develop in the laboratory environment.
This course presents the compliance standards needed to meet mandated regulations for good practice. Topics include practical applications for ensuring regulatory compliance under FDA guidelines, pharmaceutical and biotechnology company use of the graded approach for GMP regulations for
This course presents risk management solutions for Biopharmaceutical companies including those related to failure and Out of Specification investigations, approving validation protocols and reports, Deviations and CAPA, setting scientifically defensible specifications, GMP documentation requirements, establis
This course presents regulatory acts and requirements for industry compliance through readings, reference materials and laboratory work. Topics include the Food Drug and Cosmetics Act; the regulatory structure; GMP audits; drug GMP; quality Control testing requirements; stability testing and drug product exp
Source: North Shore Community College's catalog, linked per course · table learning_unit · CourseShelf publish 61
