Out of Specification Investigations
An out of specification result is treated as a problem with the sample until somebody proves otherwise, which is exactly the wrong way round. This course covers investigating them defensibly.
Course outline
What this programme covers, module by module.
- 01Assuming the sample is wrong until proven otherwise
- 02First response, retaining the data and not repeating too soon
- 03Phase one: the laboratory investigation and hypothesis testing
- 04Retesting and resampling, when each is justifiable
- 05Phase two: production, materials and the wider investigation
- 06Reaching a conclusion the evidence actually supports
- 07Invalidation, trending, repeats and what inspectors look for
What you will gain
- Respond to an out of specification result correctly
- Run a laboratory phase investigation properly
- Decide when retesting is justified and when it is not
- Extend the investigation beyond the laboratory
- Reach and document a supportable conclusion
- Handle trends, repeats and regulatory scrutiny
Who should attend
- Laboratory analysts and supervisors
- Quality assurance and quality control staff
- Production staff involved in investigations
- Regulatory affairs and compliance personnel
Upcoming sessions
| Date | City | Duration | Fees | Book |
|---|---|---|---|---|
| 3 to 4 Nov 2026 | Durban | 2 Days | R10,000 | |
| 23 to 24 Nov 2026 | Cape Town | 2 Days | R10,000 | |
| 1 to 2 Dec 2026 | Johannesburg | 2 Days | R10,000 | |
| 11 to 12 Jan 2027 | London | 2 Days | US$1,100 | |
| 9 to 10 Feb 2027 | Dubai | 2 Days | US$1,100 | |
| 3 to 4 May 2027 | Pretoria | 2 Days | R10,000 | |
| 5 to 6 Jul 2027 | Durban | 2 Days | R10,000 |
Fees are per delegate and exclude VAT. Public intakes are confirmed once minimum numbers are met. We also deliver this course on your own schedule, in-house or live online.
Enquire about this course
Register your team or ask for a tailored in-house quote. We reply within one working day.
WhatsApp usCourse brochure (PDF)- Fees from
- R10,000 per delegate
- Duration
- 2 Days
- Field
- Laboratory & Microbiology
- Formats
- In-house, public, online
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