PDA's Practical Application of Quality Risk Assessment Tools course (PDA 531) moves past the theory of quality risk management into hands-on practice with the structured tools reviewers expect to see used well: preliminary hazard analysis, FMEA and fault tree analysis. The December 2026 session runs at PDA's own training institute in Bethesda, Maryland.

Dates and format

  • Dates: 2-4 December 2026
  • Venue: PDA Training and Research Institute, 4350 East West Highway, Bethesda, Maryland
  • Format: in-person training course — PDA's listing states no virtual option
  • Organizer: Parenteral Drug Association (PDA)
  • Early registration deadline: 18 October 2026

What it covers

The course works through case studies drawn from drug substance manufacturing, packaging and labeling to demonstrate how to select and apply the right quality risk assessment tool for the decision at hand. Attendees get structured practice with PHA, FMEA and FTA across the full quality risk management cycle — identifying risks, defining risk controls, estimating residual risk, and documenting and communicating the outcome to the people who have to approve it.

Who should attend

PDA positions this for people who already apply quality risk management day to day in CMC, process development and process engineering roles — which is also why it carries a prerequisite rather than opening to anyone curious about QRM. If your team can state a risk but struggles to defend the tool it used to get there, this is a working session built around that gap, not a conceptual overview. Completing PDA 529/529.1 first means the three days in Bethesda go straight to application.

Need a broader quality program review before year-end? PDA's Cleaning Validation Workshop runs earlier in the autumn, and the full events directory lists everything we have verified.

Frequently asked questions

When and where is PDA 531, the Quality Risk Assessment Tools training course?

2-4 December 2026 at the PDA Training and Research Institute, 4350 East West Highway, Bethesda, Maryland. PDA's own event listing states these dates and venue; it does not describe a virtual attendance option.

What does PDA 531 cover?

Selecting and applying structured quality risk assessment tools — preliminary hazard analysis (PHA), failure mode and effects analysis (FMEA), and fault tree analysis (FTA) — to case studies from drug substance manufacturing, packaging and labeling, with practice on documenting and communicating outcomes to decision-makers.

Is there a prerequisite for PDA 531?

Yes. PDA's listing states that participants must have completed the Fundamentals of Quality Risk Management Training Course (PDA 529/529.1) before enrolling in PDA 531.

How much does PDA 531 cost?

PDA's published early registration rate (through 18 October 2026) is $2,249 for members and $2,699 for non-members, with a $1,749 rate for government, health authority and academic members. PDA's page does not state a standard rate after the early deadline as of this listing's verification.

Who should attend PDA 531?

Professionals who apply quality risk management tools in chemistry, manufacturing and controls (CMC), process development and process engineering — per PDA's own description of the intended audience.

Sources & further reading

  1. Parenteral Drug Association. Practical Application of Quality Risk Assessment Tools Training Course (PDA 531), 2-4 December 2026. pda.org

Event details are published by the organizer and can change. Confirm dates, venue and pricing with PDA before registering. Last verified 5 October 2026.