Implementing an Effective GLP Compliant Quality Management System

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.

Why You Should 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 Session :

• 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

Who Should Attend:

• Senior quality managers
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Production supervisors
• Manufacturing engineers
• Production engineers
• Design engineers
• Process owners
• Quality engineers
• Quality auditors
• Document control specialists

Course Director: Dr. JOHN C. FETZER

Dr. John C. Fetzer has been doing liquid chromatographic method development for over 35 years. His PhD was in studies of various types of chromatography. He has authored or co-authored over 50 papers on LC separations, has served on the advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry. He supervised the Good Laboratory Practices accreditation of a large research chromatography laboratory and has taught numerous short courses on GLP and ISO 17025 compliance.