Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations) training seminars presented by ComplianceOnline register now on FindaSeminar.com

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Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations)  

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Executive Management, Plant and Global Senior, Quality Managers, Plant and Global Quality Professionals, Plant and Global Regulatory Professionals, Plant and Global Compliance Professionals, Production Managers, Supervisors and Operators, Manufacturing Managers & Supervisors, Warehouse Managers and SupervisorsCalibration, Preventive Maintenance and Production Supervising Engineers, Process and Department Owners, Quality Engineers, Quality Auditors, Deviation & CAPA System PersonnelPlant and Global Designated Investigators and Process Improvement Personnel

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Seminar Summary:

One of the fundamental concepts of “current Good Manufacturing Practices” (cGMP) is that companies that manufacture and/or test medicines should be in a constant “State of Control”; in other words the medicines produced should have pure raw materials, appropriate equipment, cleanliness, trained personnel, accurate testing and everything documented from first to last. (see full course description)

 

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Training Course Syllabus:


Learning Objectives:


Upon completing this course participants should:



  • Understand the history and expectations for global regulators for Quality Management and a State of Control

  • Understand the vocabulary Quality Management including expectations for a “Quality Culture”

  • Understand aspects related to Quality Management from the following sources:


    • ICH-Q7 GMPs

    • ICH-Q8 Quality by Design for new and generic drugs

    • ICH-Q9 Risk Management

    • ICH-Q10 Pharmaceutical Quality System

    • ICH-Q11 Development & Manufacture of Drug Substance

    • 21CFR 210/211/820 for GMPs

    • 21CFR 314 for Post Market Surveillance

    • 21CFR Part 11 & Annex 11

    • MHRA’s Guidance on Data Integrity


  • Understand the role and importance of Documentation

  • Understand the interaction and integration required for successful GMP operations

  • How to prepare and present the State of Control to investigators during an inspection


Seminar Summary:

One of the fundamental concepts of “current Good Manufacturing Practices” (cGMP) is that companies that manufacture and/or test medicines should be in a constant “State of Control”; in other words the medicines produced should have pure raw materials, appropriate equipment, cleanliness, trained personnel, accurate testing and everything documented from first to last. (see full course description)

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