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cGMP Application for Design & Operation - Webinar

  • ID: 4061792
  • Webinar
  • 90 Minutes
  • NetZealous LLC
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This presentation is intended to help manufacturers implement cGMP quality systems and risk management approaches during commercial development and operations after the initial preclinical studies, to meet the requirements of the FDA's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211).The FDA requires comprehensive quality systems highlighting the company's consistency with the CGMP regulatory requirements for manufacturing human and veterinary drugs as well as medical devices, including biological drug products. This program also explains how manufacturers implementing good manufacturing practices managed by quality systems can be in the best compliance with parts 210 and 211.

Why should you Attend?: All individuals within a company manufacturing materials that are regulated by the country's government to ensure the design and established operations are going to be done in a way that will meet not only just the local regulations but wherever the product might be shipped as well as doing all you can minimize patient risk and increase the probability of profitability instead of paying outside contractors to fix your errors.

Areas Covered in the Session:
CGMPs and the concepts of current quality systems, including quality by design and development, risk management, CAPA, Change Control, Management Responsibilities, Resources, Manufacturing and Evaluation Activities.

Terms and Definitions - with related acronyms
Quality Management System - Quality = Profitability and does all it can to minimize operator errors
Documentation Requirements - entering data, comments and making corrections
Management Responsibility and GMP/Quality Commitment
Quality Policy - General elements of the Quality Manual and Individual Training Requirements for each job description.

Human Resources - Individual employee files providing documented evidence of required education or experience and related training for the individual's position
Purchasing, Incoming Control and Raw Material Release
Gowning, Environmental Control and Monitoring
Product Testing, Inspection and Document Review for Final Product Release
Incident Tracking, Change Control, CAPA and Annual Quality Review
Note: Product cover images may vary from those shown
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  • Jerry Dalfors Jerry Dalfors,

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  • QA Personnel
  • QC Personnel
  • Regulatory Affairs Professionals
  • Process Development Scientists
  • Project Managers
  • Operation Managers
  • Professional working in industries involved in manufacturing of food, drugs and medical equipment's regulated by government agencies
Note: Product cover images may vary from those shown