Implementing a Quality Management System 2021
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 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.
Areas Covered in the Webinar:
- 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
Free Materials:
- Proposed Rule Summary
- Cost of QMS
- GLP QMS GAP Analysis Checklist
- Sample GLP QMS Table of Contents
- Example of Process Flow & Criteria
- Required GLP SOPs
- SOP Template
- Seven Tools of Quality Management
- Terms: Define & Differentiate
Who Will Benefit:
- 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
