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EVENT DATE
Jul 2016
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Venue

Venue TBD Washington , District of Columbia
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Life Sciences Risk Management A to Z - Best Practices for Effectiveness and Efficiency

Overview

Quality Risk Management is now at the cutting edge of the life sciences industry internationally. ICH Q9 Guideline on Quality Risk Management (QRM) was incorporated in GMP by the MHRA, PIC/S and the EMEA.

Regulators expect that Quality Risk Management (QRM) is inherently built into the backbone of the Quality Management System (QMS). Pharmaceutical professionals should be able to use risk management techniques and tools based on ICHQ9 to manage product quality, manufacturing processes, validation and compliance within a risk based Quality Management System.

This highly interactive course consists of a lively mix of presentations, group exercises and discussions to provide an in-depth understanding of Quality Risk Management and know-how to be able to implement Quality Risk Management in the work place.

Learning Objective:

  • General principles and approach to risk management
  • Regulatory requirements for application of risk principles
  • Key steps and activities for a risk management program
  • How compliance and risk management are strategically used
  • Principles and requirements of ICH Q9
  • How to classify cGMP non-conformances according to risk priority
  • Hazard Analysis and Critical Control Point (HACCP) in production and process control
  • How to apply risk management principles in process design
  • How to use HACCP tables to maintain process control of production lines
  • The different tools applicable to risk management
  • Failure Mode and Effect Analysis (FMEA) for an example pharmaceutical product
  • How to apply risk management to validation

Who Will Benefit:

The course is designed to service a wide range of participants from various disciplines within the pharmaceutical and medical device industry. Typically participants will be managers or supervisors who have experiences in a GMP related environment and need QRM to perform in their current position.

  • Quality
  • Production
  • R&D
  • Validation
  • Engineering
  • Risk
  • Operations
  • Manufacturing
  • Project

Note:
Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/medical-device-pharma-risk-management-china-seminar-training-80382SEM-prdsm?channel=eventsinamerica

Notes:
Sponsorship Details:

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