Webinar Description

1. We lead in GMP training. Others follow
WEBINAR SCHEDULE
FOR 2014
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2. We lead in GMP training. Others follow
WEBINARS FOR 2014
WEBINAR
TIME
DATE
0001 How to write SOPs and Work
Instructions (WIs)
10:00 AM PST/ 1:00PM EST
January 30th 2014
0002 How to Manage the complaint
file
10:00 AM PST/1:00PM EST
May 15th 2014
0003 How to perform root-cause
Analysis
10:00 AM PST/1:00PM EST
November 13th 2014
0004 Good Laboratory Practices:
(GLPs)
10:00 AM PST/1:00 PM EST
June 19th 2014
0005 Good Documentation
Practices (GDPs): Record retention
and Quality record management
10:00 AM PST/1:00 PM EST
June 26th 2014
0006 How to Perform Product and
Process Risk management: PFMEA
and DFMEA
10:00 AM PST/1:00 PM EST
April 10th 2014
0007 How to perform Process
validation: Protocol writing
10:00 AM PST/1:00 PM EST
August 28th 2014
0008 How to manage supplier
Quality: Supplier Quality
management
10:00 AM PST/1:00 PM EST
August 14th 2014
0009 Change control: How to
perform impact assessment and
risk assessment
10:00 AM PST/1:00 PM EST
March 3rd 2014
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3. We lead in GMP training. Others follow
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ADVOCATES FOR PROACTIVE QUALITY MANAGEMENT
IN THE REGULATORY ENVIRONMENT

4. We lead in GMP training. Others follow
001: 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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5. We lead in GMP training. Others follow
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002: How to Manage the complaint File
What you will learn:
• Regulatory requirements for complaint file Management
• The Regulatory definitions for customer complaint
• How to prioritize complaints based on risk assessment
• How the complaint system is linked to your CAPA system
• Root-cause Analysis tools
Who will benefit?
• Quality Engineers
• Complaint investigators
• Manufacturing Engineers
• Quality Managers

6. We lead in GMP training. Others follow
003:
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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7. We lead in GMP training. Others follow
004:
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Good Laboratory Practices: GLPs
What you will learn:
Regulatory requirements for Good laboratory Practices
Good Laboratory Practices for research labs.
Good laboratory Practices for contract Quality labs
How to investigate OOS results in the labs
Laboratory equipment management
Deviation Management
Who will benefit?
• Contract laboratory personnel
• Laboratory managers
• Laboratory technicians
• Quality personnel

8. We lead in GMP training. Others follow
005:
Good Documentation Practices (GDP)
What you will learn:
• ISO standards for Good Documentation Practices
• WHO requirements for Good Documentation Practices
• FDA requirements for Good Documentation practices
• Good Practices in record Management
• Part 11 requirements for records
• How to develop a record retention policy
Who will benefit?
• Quality Engineers
• Quality managers
• Regulatory personnel
• Laboratory personnel
• Legal personnel
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9. We lead in GMP training. Others follow
006:
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How to Perform Product and Process Risk Management
What you will learn:
• How to perform Process failure Mode and Effect Analysis: PFMEA
• How to perform Design Failure Mode And Effect Analysis: DFMEA
• ICHQ9 requirements for product and process risk assessment
• ISO14971 requirements for risk assessment
• Use of post market surveillance data to improve the process and the
product
• Regulatory requirements for use of post market surveillance data
• Other risk Assessment tools
Who will benefit?
• Manufacturing Engineers
• Quality Engineers
• Design Engineers
• Regulatory personnel

10. We lead in GMP training. Others follow
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How to Perform Process validation
What you will learn:
Regulatory requirements for process validation
Principles behind process validation.
How to set up a validation program in your Quality system
The validation life cycle approach
The traditional validation approach: IQ,OQ,PPQ
How to write validation protocols: Contents
How to write validation reports: contents
The criteria for re-validation of a validated process
Who will benefit?
• Manufacturing Engineers
• Quality Engineers
• Validation Engineers
• Supplier Quality Personnel
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11. We lead in GMP training. Others follow
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008: How to Manage supplier Quality: Supplier Quality
Management
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What you will learn:
How evaluate suppliers
How to Qualify your suppliers
How to manage the quality of product, or service you get: SCAR
system
Supplier Quality agreement: Purpose and importance
Supplier change control: Its purpose and importance
Layers of your Approved Supplier List (ASL)
Supplier Performance Matrix
Who will benefit?
Supplier Quality Engineers
Purchasing Personnel
Upper Management
Quality Managers

12. We lead in GMP training. Others follow
009:
Change control
What you will learn:
• Regulatory requirements for change control
• The Change control life cycle
• How to perform risk assessment for a change request
• How to perform impact assessment for a change request
• 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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13. We lead in GMP training.Others follow
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REGISTRATION AND COST
Register on our webinar tab at:
http://www.eventbrite.com/org/4587528473
Cost: $ 245.00
Duration: 90 Minutes
Register today! Demand for our webinars is usually high.