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OOS In development

OOS and Laboratory Investigations

Phased out-of-specification investigations, retest rules, hypothesis testing and reporting that survives an inspection.

Duration
2.5 hours
Level
Practitioner
Lessons
6 lessons

This course is being written now

OOS and Laboratory Investigations is in development. Waitlist members receive the launch price, an early look at the curriculum and a chance to tell us which situations from their own site the course should cover.

What this course does and does not do

Covered

  • Phase I laboratory investigation and Phase II manufacturing investigation
  • Retest, resample and averaging rules
  • Reporting, batch disposition input and trending

Not covered

  • Invalidating a specific result at your laboratory
  • Analytical method development or validation
  • Batch disposition decisions, which remain with your QP

This course is professional training. It does not replace your site’s procedures, and it is not regulatory or legal advice on a specific event.

Who it is for

  • QC analysts and supervisors
  • QA reviewers
Before you decide

Do you really need this course?

10 questions from real inspection findings. Three minutes. No sign-up.

Not started

Ten questions about how out-of-specification results are really handled in your laboratory. Written from the QC deficiencies inspectors cite most. Nobody sees your answers.

For managers

Rolling oos and laboratory investigations out to a team?

The Site Readiness Programme adds a team heatmap from the self-assessment, a live session on the weakest questions, and records named by employee ID. Quote within two working days.

  • Seats for the whole team, priced per learner from 5 learners
  • Anonymised team heatmap: which questions your people fail, by chapter
  • 90-minute live session built on the team's weakest questions
See the programme

Regulations referenced

  • EU GMP Chapter 6
  • EU GMP Annex 16
  • PIC/S PE 009 Part I

Continue the path

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