Essential Contents of QRM's Risk Control Strategy Document

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Deadline: March 11, 2013 | Date: March 12, 2013

Venue/Country: san Francisco, U.S.A

Updated: 2013-01-22 19:47:46 (GMT+9)

Call For Papers - CFP

The field of Quality Risk Management (QRM) is central to the implementation of regulatory agencies’ 21st century vision for the pharmaceutical industry. QRM is being increasingly recognized as fundamental for lowering the cost of drug production while at the same time maintaining the high standards of drug quality essential for patient safety.

QRM activities involve processes, methods, and tools for identifying, assessing and managing risks. These activities are conducted in a disciplined environment and a key outcome is a Risk Control Strategy (RCS) document. It spells out a company’s current Risk Control procedures for all validatable entities in the company. Auditors begin their audits by reviewing the RCS. They expect this document to contain information that pervade quality and risk factors across the product lifecycle. This webinar will showcase the information that every RCS should contain.

Why Should you Attend:

Not only are regulatory agencies requiring life sciences companies to establish Quality Risk Management plans, but they are also increasingly focusing on the RCS and using it as the starting point for their audits. It is essential to gain an understanding of the information that regulatory agencies expect in the RCS. The webinar will focus on how the agencies audit a company’s Risk Management through the RCS. Examples of 483 and Warning letters will be provided in support of their expectations. This intermediate level webinar, for those with a working knowledge of QRM, provides good understanding of a quality risk strategy that talks “the language of risk” which is same as the auditors do.

Objectives of the Presentation:

At the end of the webinar, participants will:

Understand ICH’s Q9 process for QRM

Obtain familiarity with QRM document requirements

Review how QRM is audited

Examine two of the most commonly used model for the RCS document

Gain exposure to some 483s and WL issued for QRM

Who can Benefit:

Lead Engineers

Software Engineers

Risk Managers and Others Performing Risk Management Activities

Those involved in Process Improvement

QA

QC

Engineering

IT Personnel

Manufacturing

Validation Consultants.