WEBINAR SCHEDULE

FOR 2014

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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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ADVOCATES FOR PROACTIVE QUALITY MANAGEMENT IN THE REGULATORY ENVIRONMENT

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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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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

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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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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

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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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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

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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

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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

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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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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.

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