Pharmaceutical and Medical Device Good Manufacturing Practices - Similarities and Differences 2011
conferences > Education, Training conferences > Pharmaceutical and Medical Device Good Manufacturing Practices - Similarities and Differences
23 November, 2011
Palm Beach FL , USA
Why you should attend: As a quality professional, you desire to have the very best quality system that operates effectively, efficiently and conforms to the appropriate quality standards to meet customer and user needs. You are also aware that there is a paradigm shift from an emphasis on compliance to an emphasis on quality based systems. An understanding of this paradigm shift can be gained by comparing the compliance based Pharmaceutical GMPs with the Medical Device Quality System Regulation. ICH-Q7A will be included because it is a cross between the quality and compliance approach.
Areas Covered in the Session:
Module 1 - Introduction to Quality and Compliance Concepts
Module 2 - Differences between Medical Devices and Pharmaceuticals
Module 3 - Scope of the GMPs and the Quality Cycle
Module 4 - Standards of Quality
Module 5 - The Shifting Paradigm to Focus on Customer and User Satisfaction- The Quality Systems Approach
Module 6 - A Comparison of Definitions and Terms
Module 7 - Comparison of Personnel and Management Expectations
Module 8 - Comparing Design Requirements
Module 9 - Comparing Master Records
Module 10 - Comparing Equipment Controls
Module 11 - Comparing Material and Incoming Controls
Module 12 - Comparing the Control of Processes
Module 12 - Packaging and Labeling Comparisons
Module 13 - Laboratory Controls and Device Evaluation
Module 14 - Holding, Distribution, & Returns
Module 15 - Problem Solving-Deviations, Complaints, and CAPA
Module 16 - How about Part 11
Module 18 - Current Trends
Module 17 - Review and Wrap-up
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
[email protected]
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
Areas Covered in the Session:
Module 1 - Introduction to Quality and Compliance Concepts
Module 2 - Differences between Medical Devices and Pharmaceuticals
Module 3 - Scope of the GMPs and the Quality Cycle
Module 4 - Standards of Quality
Module 5 - The Shifting Paradigm to Focus on Customer and User Satisfaction- The Quality Systems Approach
Module 6 - A Comparison of Definitions and Terms
Module 7 - Comparison of Personnel and Management Expectations
Module 8 - Comparing Design Requirements
Module 9 - Comparing Master Records
Module 10 - Comparing Equipment Controls
Module 11 - Comparing Material and Incoming Controls
Module 12 - Comparing the Control of Processes
Module 12 - Packaging and Labeling Comparisons
Module 13 - Laboratory Controls and Device Evaluation
Module 14 - Holding, Distribution, & Returns
Module 15 - Problem Solving-Deviations, Complaints, and CAPA
Module 16 - How about Part 11
Module 18 - Current Trends
Module 17 - Review and Wrap-up
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
[email protected]
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
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