Upload
cgmp-university-inc
View
174
Download
0
Tags:
Embed Size (px)
DESCRIPTION
Webinar Description
Citation preview
WEBINAR SCHEDULE
FOR 2014
We lead in GMP training. Others follow 1
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
We lead in GMP training. Others follow 2
ADVOCATES FOR PROACTIVE QUALITY MANAGEMENT IN THE REGULATORY ENVIRONMENT
We lead in GMP training. Others follow 3
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
We lead in GMP training. Others follow 4
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
We lead in GMP training. Others follow 5
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
We lead in GMP training. Others follow 6
004: 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
We lead in GMP training. Others follow 7
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
We lead in GMP training. Others follow 8
006: 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
We lead in GMP training. Others follow 9
007: 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
We lead in GMP training. Others follow 10
008: How to Manage supplier Quality: Supplier Quality
Management
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
We lead in GMP training. Others follow 11
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
We lead in GMP training. Others follow 12
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.
We lead in GMP training.Others follow 13