cgmpuniversity: webinar scheduled 2013

7/29/2019 cGMPUniversity: Webinar Scheduled 2013

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WEBINARS FOR 2013

WEBINAR 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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:Principles of Corrective Action and Preventive Action

(CAPA)

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

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


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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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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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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GMP for dietary supplements

Regulatory requirements for supplements

Production and process controls.

Labeling and advertising requirements

Quality control for supplements Record keeping for dietary supplements

Manufacturing personnel

Marketing managers Regulatory personnel

Quality personnel



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00007:

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

Quality professional

Manufacturing Engineers Process Engineers

Personnel in startup companies



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00008: How to Perform Quality Risk Management,(QRM)

ICHQ9 Regulatory requirements for supplements

Production and process controls.

Labeling and advertising requirements

Quality control for supplements Record keeping for dietary supplements

Manufacturing personnel

Marketing managers Regulatory personnel

Quality personnel



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00009:

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

Nonconformance investigators

CAPA investigators Manufacturing Engineers

Quality Engineers



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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.


cgmpuniversity: webinar scheduled 2013

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