cGMP University - GMP/CGMP (Good Manufacturing Practice) information, regulations and literature for pharmaceutical industry. cgmp provides state of the art GMP know how that gives guidance in your business.

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WEBINAR SCHEDULE
2013
FINAL

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WEBINARS FOR 2013
WEBINAR TIME DATE
0001 Principles of Corrective 11:00 AM PST/ 2:00PM EST March 19th 2013
Action and Preventive
Action(CAPA)
0002 How to Manage the 11:00 AM PST/2:00PM EST January 22nd 2013
complaint file
0003 Change control 11:00 AM PST/2:00PM EST November 20th 2012
0004 Design controls for medical 11:00 AM PST/2:00 PM EST May 14th 2013
device
0005 Laboratory controls for the 11:00 AM PST/2:00 PM EST June 16th 2013
Pharmaceutical industry
0006 GMP for dietary 11:00 AM PST/2:00 PM EST June 23rd 2013
supplements
0007 How to write SOPs and 11:00 AM PST/2:00 PM EST July 2nd 2013
Work Instructions
0008 How to perform Quality Risk 11:00 AM PST/2:00 PM EST August 20th 2013
Management (QRM)
0009 How to perform Root Cause 11:00 AM PST/2:00 PM EST September 17th 2013
Analysis

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WHAT YOU WILL LEARN

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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 validation
Who 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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REGISTRATION AND COST
Register on the webinar tab at: http://www.cgmpuniversity.com
Cost: $ 245.00 Per 1hour webinar.
Register today! Demand for our webinars is usually high.
APPROVED
By DAVID MUCHEMU at 10:56 pm, 10/10/12