Quality and Compliance Presentations

In addition to working in the field of adhesives, Dr. Steiner has also advised companies about quality and compliance. The two attached presentations presentations provide an example of Dr. Steiner’s passion in these areas.

Available for adhesive consulting &
adhesive expert witness services.

The first, entitled “A Graded or Risk Based Approach to cGMP Compliance for API Manufacturing” covers such topics as: Regulatory Status of APIs in the US, Q7A, ICH, API Production Designation, and the spectrun of cGMP Controls.

The second, entitled “Project Elements of Design Control, Design of Experiment (DOE) and Risk Analysis (FMECA)” covers such topics as: History of “Quality” and roots of Design Control and Risk analysis, Failure Mode and Effects Analysis (FMEA), DFMEA, PFMEA, Failure Mode, Effects, and Criticality Analysis (FMECA ), Product Development Process, MIL STDS, International Organization for Standardization (ISO) 13485, 14971, FDA QSR 820.30(c) and (g), Medical Device Directives, Design Control and Design of Experiments (DOE), and Risk Analysis among other topics.Project Elements Design Control and Risk Analysis.

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