BioStart Biomanufacturing Foundations

How a life sciences company forms and grows, from founding and funding through its core functions, cross-functional teams, and key external partners such as regulators, CROs, and CDMOs.

A practical orientation for new operators and technicians: upstream and downstream processing, process monitoring (CPPs and CQAs), equipment qualification, shift handoffs, materials traceability, maintenance, and production records.

Why the industry is regulated, the FDA's authority and key regulations (21 CFR Parts 210, 211, and 820), how GMP compares with GLP and GCP, what an FDA inspection involves, and each employee's role in quality.

How to read, navigate, and follow an SOP exactly, use controlled documents correctly, and respond when a situation doesn't match the procedure, including deviations and change control.

What makes GMP records trustworthy: ALCOA+ principles, correct entries and error corrections, second-person review, paper and electronic records, and the basics of 21 CFR Part 11.

Types and routes of contamination, how facility design controls them, cleanroom classifications (ISO 14644-1 and GMP Grades A to D), gowning, and cleaning, sanitization, and sterilization.

A primer on the biology and chemistry behind biomanufacturing, from chemistry and cell biology to molecular biology, microbiology, immunology, and analytical techniques, with workplace context throughout.

Applied math taught through workplace scenarios: metric conversions, scientific notation, significant figures, reading instruments against specifications, dilutions (C₁V₁ = C₂V₂), and basic QC statistics.

The reasoning behind SOPs and records: key quality standards (ISO and ICH Q9(R1)), risk-based thinking, sources of variation, preventive controls, the duty to report, CAPA, and the State of Control.

A plain-language introduction to Lean with life sciences examples: customer value, the eight wastes, process and value stream mapping, pull and kanban, 5S, mistake-proofing, and Kaizen events.

From the PDCA cycle to DMAIC: what Six Sigma means, Voice of the Customer, defining a problem, root cause analysis (Five Whys and fishbone diagrams), and control plans and charts.

Every Course Includes

• Clear learning objectives
• Interactive activities
• Assessments
• Progress tracking
• Learn at your own pace

Built with Industry

Learning objectives are shaped by employer feedback on what new team members need to know. Courses are developed with subject matter experts and professional instructional designers.