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PDA Quality Risk Management Certificate Program

This first-of-its-kind Program in the industry delivers role-based training to help your company improve its quality risk management (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

To maximize the benefit of this unique training opportunity, select the track that best suits your needs to gain knowledge and proficiency in fulfilling your unique role at your company:

  • QRM Foundations Track: The training course, “Foundations of Quality Risk Management,” 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 like quality assurance, quality control, engineering, validation, production and technical services who are involved in QRM activities. This training course is a prerequisite for all tracks listed below.
  • 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.
  • 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.

Attendees who have taken the QRM Application Track have the opportunity to register for PDA's newest QRM training course:

  • 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.
 
Available Tracks
  • QRM Foundations
  • QRM Decision Maker
  • QRM Application
Available Electives
  • Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems

Required Training Courses

QRM Decision Maker
  • Foundations of Quality Risk Management
  • Quality Risk Management: Risk Control and Risk-Based Decision-Making
QRM Application
  • Foundations of Quality Risk Management
  • Practical Application of Quality Risk Assessment Tools
Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems Training Course
  • Foundations of Quality Risk Management
  • Practical Application of Quality Risk Assessment Tools