This course will cover application of various quality risk assessment tools and considerations for tool selection. Different case studies from drug substance manufacturing and packaging and labeling will be used to demonstrate application of the various tools.
Learners will understand how to apply the formality spectrum for tool selection and learn where simpler risk assessment tools can be more useful instead of detailed tools. They will also learn how different tools can be applied in combination to address a risk question.
Additionally attendees will get hands-on practice with the more detailed and structured risk assessment tools - PHA, FMEA and FTA as follows. In each of the application case studies all stages of the QRM process will be covered including identification of risks, risk controls, estimating residual risks, practicing documentation and communication of outcome to management, and obtaining approval from decision makers.
- First, learners will practice performing a preliminary hazard analysis (PHA) to identify hazards, harms, and hazardous situations associated with a proposed protein drug substance packaging suite, and a bottling and packaging operation of oral non-sterile liquid product.
- Second, learners will perform a failure mode and effect analysis (FMEA) to assess the potential product quality risks associated with a protein A chromatography process, and a secondary packaging components production process. Application of FMEA will include identifying specific failure modes, failure effects, and cause of the failures associated with potential risks during manufacturing and packaging.
- The third case study involves use of the fault tree analysis (FTA) to identify and assess potential product quality risks, specifically with a virus contamination event in cell culture, and packaging, handling and transport of liquid filled glass syringe.
IMPORTANT NOTE: Participants enrolling in this course must have completed one of the following PDA courses:
- Foundations of Quality Risk Management scheduled on December 11, 2017, July 9, 2018, or November 5, 2018 at the PDA Training and Research Institute in Bethesda, Maryland.
- Any offerings of the prior PDA course, Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations
Additionally, participants should have read PDA Technical Report 54 (TR 54), Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.
Who Should Attend
The QRM Application track includes two courses: “Foundations of Quality Risk Management” and “Practical Application of Quality Risk Assessment Tools.” This training module 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.