Documenting a Risk-Based Quality System - for Compliance and Cost-Savings

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Oct 07, 2014
90 Minutes
Product Description

Create a Risk-Based Quality System That Can Withstand a FDA Audit with the Help of this Session

Risk-based quality systems are the core requirement of all FDA-regulated organizations. These systems aim to reduce the overall incidences of risk events and adequately manage those risk events that occur, to minimize their impact on the overall functioning of an organization. FDA requires detailed documentation of the assessment of each risk event, its causes, corrective and preventive measures, and training and cumulative trend analysis of risk events in a given period. A key competency of a regulated organization is the ability to identify potential risks and implementing measures to manage them.

Join Dr. Mukesh Kumar in this 90-minute audio session, to know the basics of risk-based quality systems, analysis techniques and practical tips using case studies. He will provide practical instructions for creating well documented risk-based quality systems that can withstand an FDA audit and enhance the performance goals of a given organization.

This audio conference is intended for general instructions to all FDA regulated organizations such as manufacturers, laboratories, clinical sites, and importers and exporters of products, who wish to have a better understanding of how FDA audits quality systems. Attendees will be introduced to the core components of a quality management system (QMS). Similar principles are applied by EMA and other regulators. Dr. Kumar will shed light on the common FDA audit findings and its potential solutions using examples from different kinds of operations.

Topics covered in the session:

  • Elements of a risk-based quality system
  • Related FDA regulations and guidance documents
  • Documentation required by FDA
  • Automated and manual documentation systems
  • Electronic filing systems
  • Reports due to FDA
  • What is subject to audit and what is optional

In all organizations, quality systems exist to reduce the risk of undesirable events. In FDA regulated institutions, the main purpose of a Quality Management System (QMS) is implementing measures to limit the impact of the risk events. FDA requires a QMS to be based on risk assessment of the tasks performed and evaluates their effectiveness in controlling and managing risk events. The elements of the QMS at a given organization vary depending on the tasks performed but the core principles are similar. Deficiencies in QMS systems are frequently cited in Warning Letters and 483s.

Get answers to your queries in Q&A segment from the speaker at the end of the session.

Who should attend:

  • Quality assurance personnel
  • Project Managers
  • Regulatory Vice Presidents, Directors and Managers
  • Clinical trial professionals
  • GMP and GLP professionals
  • Auditors
  • IT professionals in automated QMS
  • Attorneys – In-house or Outside Counsel

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About Our Speaker

Dr. Mukesh Kumar - Pharma Regulation Expert

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...   More Info
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