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CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training
September 21, 2010 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This online training course is intended for professionals in the Pharmaceutical industry. It will be especially valuable to the following individuals and disciplines:
• Executive managers (CEO, COO)
• Senior managers
• Middle managers
• Quality managers
• Quality Assurance
• Regulatory Description
In 2001 the US FDA began using a system based approach to inspections and one of the systems listed in the inspectional guidance is the Quality System. In 2004 the FDA issued: Guidance for Industry - Quality Systems Approach to Pharmaceutical CGMP Regulations as a draft guidance. It was finalized in 2006. Then in May, 2007 the ICH published ICH Q10, Pharmaceutical Quality System, which was revised in June 2008. The FDA is encouraging the pharmaceutical industry to implement Quality Systems, yet it is not clear what constitutes a Pharmaceutical Quality System.
This 90-minute accredited training will discuss the concept of a quality system and how the FDA guidance, ICH guidance and other quality standards relate to one another. Elements of a Pharmaceutical Quality System will be delineated and a framework for the PQS suggested. In addition to the course notes handout, relevant material including the ICH Q10 FDA Guidance will be included for download.
Module 1: What is a Quality System
• The Quality System in FDA Systems Inspection
• FDA Guidance on the Quality System Approach to GMPs
• ICH Q7
• Quality System vs. Quality Management System
• ICH Q10- Pharmaceutical Quality System
• Other Quality Systems
Module 2: What is a Pharmaceutical Quality System
• The System as described in ICH Q10
• Management responsibilities
• Product Lifecycle
• PQS elements
• Enablers
Module 3: What should be in a Pharmaceutical Quality System
• Suggestions from the Quality System Guidance
• CGMPs
• Contemporary elements
Where to start when implementing the Pharmaceutical Quality System
• Identify organizational needs
• Select a framework
• Transition from current state to the desired state
Question and Answer Session
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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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John G. (Jerry) Lanese, Ph.D., president, The Lanese Group, Inc.
Jerry Lanese, Ph.D., CMC is the president of The Lanese Group, Inc, an independent consulting service provider that specializes in Quality Systems and Laboratory Controls. Dr. Lanese has taught at the college level and worked in various Quality Control and Quality Assurance roles in small and large pharmaceutical firms. For the last 15 years he has consulted in a wide range of projects from consent decree remedial actions with large pharmaceutical firms to systems development for a small component manufacturer. Dr. Lanese has lectured throughout the world to clients and for major seminar providers and was voted the best presenter of the year in 2001 by the Institute of Validation Technology. In 2008 he received the Kenneth Chapman Industry Recognition Award.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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