Current Good Manufacturing Practice (cGMP)

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Getting the Most Out of TOC: How to Improve Data Quality and Increase Productivity

Complimentary Learning Level: Beginner/Intermediate Session Length: 1 hour Total organic carbon (TOC) and conductivity are important quality attributes in cGMP manufacturing for water monitoring and cleaning validation...
Creating Effective Standard Operating Procedures
Features
Creating Effective Standard Operating Procedures
Personnel management is the most challenging variable in maintaining current Good Manufacturing Practice (cGMP) across the life cycle of drug manufacture, safety, and supply. A standard operating procedure (SOP) outlines agreed-upon instructions for personnel training and instructions for maintaining systems, machines, documents, and records in a qualified state to produce safe products. This...
Video

Defining and Achieving Operational Readiness Webinar

Learning Level: Intermediate - Preparing for full GMP operations requires effective development and deployment of production equipment, procedures, and processes. However, as many experienced leaders can attest, full...
A Prescription for Success
iSpeak Blog
A Prescription for Success
How CMOs keep conditions controlled and reduce costs with temporary power, climate control, 100% oil-free air