PDA Quality Risk Management Certificate Program

PDA is launching its new 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 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 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.
• QRM Facilitator Track: Coming in 2018, this track will be the most comprehensive of the four tracks and is applicable to individuals who are expected to be highly skilled and proficient in the entire QRM process and its application, including the use of the various QRM tools. QRM facilitators can reside in various functions across an organization including project management, operational excellence and technical functions.

Required Courses