Why Should You Attend:
Medicine quality requires meeting regulations and established specifications. Quality management in pharmaceutical industries is an important subject because the products are delivered directly into the consumers body, thus identity, purity safety and ultimately appropriate quality of product are critical. Ultimately the quality of pharma products is a legal issue and must be maintained in pharmaceutical products. In today’s highly regulated and competitive environment, with many existing drugs coming off patent and delivery to market slowing, companies often forget about quality processes.
In August of 2016 the Department of Health and Human Services (HHS) of the Food and Drug Administration (FDA) submitted a proposal amending 21 CFR 58, Good Laboratory Practice for Nonclinical Laboratory studies (The Proposed Rule) in an effort to focus on quality, combat the decline in new drugs to market and standardize international requirements. One of the critical changes required by this amendment requires nonclinical laboratories to follow a complete quality management system (QMS) approach when conducting safety and toxicity studies intended to support applications and submissions to the FDA.
While this proposed amendment has not been ratified, the benefits of a clear and effective GLP QMS are proven, documented and quantifiable. A GLP QMS can provide for the alignment of FDA regulations with other existing international (OECD) and domestic (EPA) GLP regulations, the reduction of duplicative efforts and development costs, more effective compliance and resource allocation while ensuring the uniformity, consistency, reliability, quality, reproducibility and integrity of GLP study data submitted to the FDA.
Areas Covered in the Webinar:
Who Will Benefit:
John C. Fetzer, has had over 30 year experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers on liquid chromatography, has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bio analytical Chemistry.
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