VIEWS: 91 PAGES: 2 CATEGORY: Healthcare & Medicine POSTED ON: 7/6/2012
Overview: Ensuring GCP quality has often been approached from the perspective of reviewing as many documents as possible, looking for errors and following up on corrections or making "notes to file." In order to design, implement, and maintain GCP compliance in an effective manner, a Quality Systems Approach should be adopted.
RAPS Approved Webinar on Implementing a Quality Systems-Based Approach to GCP Compliance Date & Time: Course "Implementing a Quality Systems-Based Approach to GCP Compliance" has been pre-approved by RAPS as eligible Register Now for up to 1.00 credits towards a participant's RAC recertification upon full completion. Instructor Profile: Tuesday, August 7, 2012 10:00 AM PDT | 01:00 PM EDT Amnon Eylath Duration: 60 Minutes Instructor: Amnon Eylath Director Global Quality, Ariad Pharmaceuticals Location: Online Price : $245.00 (for one participant) Amnon Eylath is Director of Quality at Ariad in Cambridge, Overview: Massachusetts. He is responsible for Ensuring GCP quality has often been approached from the global oversight of the QA/QC perspective of reviewing as many documents as possible, looking for aspects of Drug Substance and Drug errors and following up on corrections or making "notes to file." In Product Manufacturing, Testing, Stability, Packaging and Distribution, order to design, implement, and maintain GCP compliance in an as well as oversight of compliance effective manner, a Quality Systems Approach should be adopted. In for Pre-Clinical (GLP) and Clinical the GMP and GLP domains, this approach has led to more effective (GCP) Studies. Amnon has over 20 and efficient maintenance of compliance, since only by implementing years of experience in medical effective systems can quality and compliance be established, research, process & method monitored, and then maintained. Your speaker will describe the GMP development, device development, Quality System, and how, in a similar manner, a GCP Quality System facility/process design and can be utilized by ensuring the proper establishment of investigator validation, GxP audits and regulatory compliance, CMC support, oversight and documentation; IRB oversight; sponsor monitoring; development and deployment of corrective and preventive action (CAPA) execution; IP controls; quality systems, as well as Clinical Staff and lab qualification. Your speaker will discuss each sub disposition of Biotech and Small system in detail, why it exists, and how working together, they Molecule clinical materials for US and protect patient safety, rights, and welfare. Your speaker will present international use. proposals for adopting this approach at clinical sites, as well as the role of the sponsor in establishing internal GCP quality systems, and Amnon is currently is leading the ensuring compliance at the sites and CROs. The topic of auditing from development of a technical report on the application of cGMP and Quality a Quality Systems-Based Approach will also be discussed. Your Systems for the complete speaker will also address why it is difficult to get clinical sites to use development life-cycle of Biotech a "systems" approach and will give real-life examples of failures to Drug Substance, in collaboration with deploy and implement these systems properly based on recent industry and regulatory agency warning letters from FDA. representatives. He is also a core member of industry Task Forces developing technical reports for Areas Covered in the Session: application of GMPs to Investigational Medicinal Product, l Background for Clinical Trials and GCP (Good Clinical Practice) Development of Specifications for Early Phase drug development and l The benefits of a Quality System approach Risk-Based auditing. He has recently l GCP Quality System commented to changes in Eudralex l The Importance of the sub-systems: PI Oversight and Record regulations covering drug Keeping; IRB Oversight; Monitoring; Clinical Staff and 3rd Party development. He has also lectured at Qualification; IP Handling; Pharmacovigilance/Patient Safety Moorpark College, UC Davis and l GCP Compliance Audits Indiana University on Quality and l Ranking the Severity of Observations Pharmaceutical Technology subjects, l Resolutions of Deviations and was instrumental in the establishment of the Biotechnology l References certification and degree programs (respectively) at Moorpark College Click here to register for this webinar and Indiana University....more Who Will Benefit: Suggest a Topic More Webinars l Auditors Your Necessity is our Priority l Study Coordinators l Managers l Directors l Principle Investigators It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. 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