A Quality Calibration Program (QCP)
for Biotech and Pharmaceutical Companies:
Meeting FDA Calibration Requirements v2.0
A complete tutorial on one CD

Topics covered on this CD include:
The criticality of calibration; A short history;
Requirements:
21 CFR Part 820.72 (FDA – QSR), 21 CFR Part 820.25, 21 CFR Parts:
58, 110, 121, 145, 211, and 606, ISO 9000, ISO 13485;
A Quality Calibration Program:
Calibration procedures, Formatting,
Document control, Updating and improving them, Training and
availability, Validation vs. qualification;
Calibration records:
Specific requirements, Formatting, Filing, Correcting your records,
Calibration labels, Calibration intervals, Calibration certificates,
Traceability, 4:1, Uncertainty budgets, Environmental requirements,
Out of tolerance procedures;
Managing a Quality Calibration Program:
Setting up a new metrology department, Calibration Standards;
Best Practices and Lessons Learned:
Scheduling and inventory control, Calibration
management software, Continuous process improvements, Short cycling,
Limited calibrations, PMIs, Calibration extension programs, The SI,
Getting the most out of your balances, Accuracy vs. precision,
In-house calibration vs. contract and external calibration labs,
Quality documents and procedures, Audit preparation, Ethics, Safety,
and Resources.
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