The GMP Training Academy
Management Review of the Quality System
€179 excl. VAT (€216.59 incl. VAT)
per person, twelve months of access
- Format
- Online, self-paced
- Time
- 2 to 3 hours, self-paced
- Level
- Essentials
- Certificate
- Assessed, verifiable ID
Purpose
Turn management review from an annual formality into the decision forum ICH Q10 and EU GMP Chapter 1 expect: the right inputs, honest metrics, decisions with owners and records that survive an inspection.
Learning outcomes
- Explain to a site leadership team what management review is for and what a regulator will ask them about it
- Build an input pack from the quality system that covers every element ICH Q10 3.2.4 and 4.1 and EU GMP 1.6 expect
- Select and present metrics and trends that support decisions rather than decorate them
- Run a review with an agenda, defined roles, an escalation path and time for debate
- Record outputs as decisions, resources and actions with owners, dates and follow-up
- Produce minutes and an action log that demonstrate senior management ownership to an inspector
What the site gets back
- A management review an inspector can follow from inputs to decisions, reducing the chance of a finding against EU GMP 1.5 to 1.6 or ICH Q10 4.1
- Templates (agenda and input pack, action and decision register, minutes) adopted by the site, so every review is compiled and recorded the same way
- A certificate with a verifiable ID for the training matrix, checkable by an auditor
- Actions from the review that are closed and checked, because outputs are written with owners, dates and follow-up rather than assumed
Modules
- 1. What management review is for
- 2. Build a pack that tells the truth
- 3. Run a review that decides
- 4. Produce outputs that change something
- 5. Close the loop
Regulatory mapping
EU GMP Ch. 1 (1.5, 1.6, 1.10 to 1.11); EU GMP Ch. 2 (2.1 senior management); ICH Q10 (Section 2, 3.2.4, 4.1 to 4.4); PIC/S PE 009 (Ch. 1, 1.5 to 1.11); EMA GMP/GDP IWG (Q&A and inspection guidance).