cgmp university - gmp training and proactive quality management | compliance resolution
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WEBINARS FOR 2013WEBINAR TIME DATE0001 Principles of CorrectiveAction and PreventiveAction(CAPA)
11:00 AM PST/ 2:00PM EST March 19th 2013
0002 How to Manage thecomplaint file
11:00 AM PST/2:00PM EST January 22nd 2013
0003 Change control 11:00 AM PST/2:00PM EST November 20th 2012
0004 Design controls for medicaldevice
11:00 AM PST/2:00 PM EST May 14th 2013
0005 Laboratory controls for thePharmaceutical industry
11:00 AM PST/2:00 PM EST June 16th 2013
0006 GMP for dietarysupplements
11:00 AM PST/2:00 PM EST June 23rd 2013
0007 How to write SOPs andWork Instructions
11:00 AM PST/2:00 PM EST July 2nd 2013
0008 How to perform Quality RiskManagement (QRM)
11:00 AM PST/2:00 PM EST August 20th 2013
0009 How to perform Root CauseAnalysis
11:00 AM PST/2:00 PM EST September 17th 2013
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00001:Principles of Corrective Action and Preventive Action(CAPA)
What you will learn:
• CAPA life cycle: From discovery to CAPA closure
• QSR requirements for a CAPA system
• How to initiate Corrective Action and preventive Action
• How to Prioritize nonconformities using QRM
• Root-cause Analysis tools
Who will benefit?
• Quality Engineers
• Nonconformance investigators
• Manufacturing Engineers
• Quality Managers
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00002: How to manage the complaint system
What you will learn:
• Regulatory requirements for the complaint system
• Using Quality Risk Assessment to prioritize complaints
• How to initiate complaint investigation
• How to manage the complaint system
• Complaint system metrics
Who will benefit?
• Quality Engineers
• Complaint investigators
• Complaint system managers
• Quality Managers
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00003: Change control
What you will learn:
• Regulatory requirements for change control
• The Change control life cycle
• How to perform risk assessment
• How to perform impact assessment
• Performance matrix for a change control system
Who will benefit?
• Validation Engineers
• Change control managers
• Quality system managers
• Supplier Quality professional
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00004: Design controls for medical device
What you will learn:• Regulatory requirements for design controls• The device design life cycle• Contents of the Design History File (DHF)• Product design models for medical device• Design change control and design validationWho will benefit?
• Product design Engineers• Project managers• Quality system managers• Quality Engineers
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00005: Laboratory controls for the Pharmaceutical industry
What you will learn:
• Regulatory requirements for laboratory controls
• Good Laboratory Practices, GLP.
• How to investigate OOS results
• Laboratory equipment management
Who will benefit?
• Contract laboratory personnel
• Laboratory managers
• Laboratory technicians
• Quality personnel
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00006: GMP for dietary supplements
What you will learn:
• Regulatory requirements for supplements
• Production and process controls.
• Labeling and advertising requirements
• Quality control for supplements
• Record keeping for dietary supplements
Who will benefit?
• Manufacturing personnel
• Marketing managers
• Regulatory personnel
• Quality personnel
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00007: How to write SOPs and Work Instructions.
What you will learn:
• Document hierarchy in the Quality system
• How to write a Quality manual.
• How to write a Quality policy
• How to write a standard operating procedure, SOP
• How to write Work Instructions
Who will benefit?
• Quality professional
• Manufacturing Engineers
• Process Engineers
• Personnel in startup companies
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00008: How to Perform Quality Risk Management,(QRM)
What you will learn:
• ICHQ9 Regulatory requirements for supplements
• Production and process controls.
• Labeling and advertising requirements
• Quality control for supplements
• Record keeping for dietary supplements
Who will benefit?
• Manufacturing personnel
• Marketing managers
• Regulatory personnel
• Quality personnel
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00009: How to Perform Root-cause Analysis, (RCA)
What you will learn:
• Root cause Analysis methods
• Root Cause Analysis tools
• How to choose the right tool for the right job
• How to categorize problems and potential problems
• Contents of an investigation record
Who will benefit?
• Nonconformance investigators
• CAPA investigators
• Manufacturing Engineers
• Quality Engineers
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