Simplifying Global Compliance
Process expert, Jerry Dalfors — has trained FDA field investigators, written & supported FDA’s work on Process Validation guidances — leads you through the intricacies of developing & improving BPRs and DHRs.
If you're like many manufacturers, you understand the essence of the 21 CFR 820.30 requirement: you must run enough test samples of a product so its test results can be successfully applied to full-scale production runs.
Is your informed consent process effective and compliant with FDA and OHRP? If you hesitated for even a moment, kindly accept this invitation to preview — at no risk — the 2015 edition of … Informed Consent for Clinical Trials: A Regulatory Reference Guide.
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