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Site language : English - Français
Ref : 29377
Event :Implementing a Quality Management System

Date :Wednesday April 24th, 2019

Location :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

Editorial

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.

Objectives

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.

Program

  • GLP Regulations
  • Quality Management System (QMS)
    • Definition
    • Principles
    • Purpose
    • Function
    • Elements
  • Quality Policy
  • Quality Objectives
  • Quality Manual
  • GLP SOPs
  • Plan, Do, Check, Act Cycle
  • GAP Analysis
  • QMS Implementation Steps
  • Process Control and Optimization Theory
  • Process Criteria
  • Quality Audit
  •  

Speakers

William D Fox

William D Fox
Quality Management Professional, Texas Biomedical Research Institute

William D Fox is a quality management professional with a background in clinical research and quality assurance. William’s experience includes scientific, administrative, and quality aspects of regulated (ISO, GCP, GLP, GMP) pharmaceutical development and manufacturing and spans the translational interface (T1; late preclinical, early clinical) with a focus on oncology drug development and emerging disease vaccine development in BSL 2, 3 & 4 environments. William also has experience developing quality management systems, documents and change control systems in GLP, GCP and GMP settings.

 
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Location

Map and directions
Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions

Further information

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Details

Implementing a Quality Management System Management
glp quality system, glp quality management system, glp requirements, glp qms, glp regulations, proposed rule for glp quality system, 21 cfr 58, pdca cycle
Professionals, Senior Managers, Managers & Supervisors Process Owners Departmental Heads Quality System, QA, QC and Continuous Improvement Managers and Personnel Quality Consultants Regulatory and Compliance Managers Change Control/Documentation Staff
10 -- --
English

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