This GLP quality system webinar provides a general overview of the Proposed Rule, a GLP QMS and its implementation, GAP analysis, Plan-Do-Check-Act cycle, process control and optimization theory and quality audits are utilized for the analysis of an existing QMS and the potential benefits, barriers steps to implementing an optimized GLP QMS.
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:
Vice President, Americas Quality Operations at Stallergenes Greer
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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