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PDA Quality Risk Management Training Courses

The role of Quality Risk Management (QRM) is integral in supplying and maintaining quality products by evaluating manufacturing processes and understanding risks to product quality and thus patient safety. With a critical understanding of QRM, the quality of products can be built into the manufacturing processes. PDA’s Quality Risk Management Training Courses cover the integration of QRM principles, as well as effective and practical application of QRM, into pharmaceutical manufacturing systems throughout the product lifecycle.

PDA also offers the Quality Risk Management Certificate Program which delivers role-based training to help companies improve their QRM process to ultimately ensure the delivery of higher-quality, safe medications to patients. Nowhere else can you receive training on the critical aspects of the QRM process from noted industry experts intimately involved in the development and implementation of the ICH Q9 guidance and with years of experience in training and practical application of QRM principles. See which track below best suits your needs to gain knowledge and proficiency in fulfilling your unique role at your company.

QRM Foundations Track

This track is designed for all personnel involved in quality risk management activities, as a participant in risk assessments, QRM facilitator or decision maker. This includes personnel from disciplines such as quality assurance, quality control, engineering, validation, production and technical services who are involved in QRM activities. This track consists of the following training course(s):

  • Technical Report No. 54: Foundations of Quality Risk Management
QRM Decision Maker Track

This track is applicable to supervisors, managers and directors from disciplines such as quality assurance, quality control, engineering, validation, production and technical services, who often make decisions based on the outcomes of risk assessments for their areas of responsibility. How well decision makers understand and execute their roles in the QRM process has a direct impact on the effectiveness of risk mitigation and product quality. Misinformed decisions can result in inadequate mitigation of product quality risks and ultimately lead to product defects and product recalls; find out how to protect against such outcomes by enabling robust risk-based decisions. This track consists of the following training course(s):

  • Technical Report No. 54: Foundations of Quality Risk Management
  • Quality Risk Management: Risk Control and Risk-Based Decision-Making
QRM Application Track

This track is applicable to pharmaceutical professionals engaged in QRM application activities related to chemistry, manufacturing and controls for pharmaceutical and biotechnology processes. This includes: manufacturing supervisors/managers/directors, process development biochemists, microbiologists, cell biologists and molecular biologists, process engineers, quality assurance professionals, regulatory CMC supervisors/managers/directors, quality control and analytical development professionals. This track consists of the following training course(s):

  • Technical Report No. 54: Foundations of Quality Risk Management
  • Technical Report No. 54-2 and 54-4: Practical Application of Quality Risk Assessment Tools

Attendees who have taken the QRM Application Track have the opportunity to register for PDA's newest QRM training course: Technical Report No. 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems. This new training course is applicable to supervisors, managers, specialists, analysts, and technicians from disciplines such as quality, regulatory affairs, manufacturing, validation, and engineering who are responsible for quality risk management in manufacturing.

Whether it's a QRM standalone training course or a QRM track, you're sure to receive invaluable information that you can take and apply on the job. See below for our current offerings on QRM.