| 00:00:00 | Instrument |
| 00:01:18 | Instrument performance verification in laser diffraction |
| 00:02:26 | Abstract |
| 00:02:54 | Essential reference (“Reference 1”) |
| 00:03:37 | Reference 2 |
| 00:03:51 | Reference 3 |
| 00:04:05 | Reference 4 |
| 00:04:23 | What do I need to think about and define before I even attempt a particle size measurement? |
| 00:06:53 | In QbD speak….. |
| 00:08:29 | What does it cost if you get it wrong? |
| 00:09:06 | FDA Warning Letter (“483”)See: http://en.wikipedia.org/wiki/Form_FDA_483 |
| 00:09:54 | Contrast verification and validation |
| 00:10:34 | Fit-for-purpose |
| 00:11:23 | Up to date! |
| 00:11:45 | USP <1058> [From: Chapter 1 Reference 1] |
| 00:12:44 | USP <1058> Analytical Instrument Qualification |
| 00:13:11 | USP <1058> Analytical Instrument Qualification |
| 00:13:58 | 4 stages [From: Chapter 1; Reference 1] |
| 00:14:04 | Parameters [From: Reference 1] – note ‘validation’ |
| 00:14:45 | FDA – this is into PQ |
| 00:15:34 | Reference 2 |
| 00:16:14 | Who does it [From Reference 1] |
| 00:17:14 | From Reuter (Reference 3) |
| 00:17:45 | The (Bob) McDowall analogy http://www.rdmcdowall.com/ |
| 00:18:15 | The FDA perspective (the PQ part)http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM359266.pdf |
| 00:18:47 | FDA |
| 00:19:13 | FDA |
| 00:19:32 | FDA guidance – February 2014 |
| 00:20:20 | FDA Guidance - Decision Tree 3 |
| 00:21:04 | Remember! |
| 00:22:07 | Validation Master Plan (VMP) |
| 00:23:05 | Validation Master Plan (VMP) |
| 00:23:44 | IQ/OQ – Installation and Operation Qualification |
| 00:25:02 | USP <1058> Analytical Instrument Qualification |
| 00:25:50 | What is the IQ/OQ limited to? |
| 00:27:03 | What is the PQ? |
| 00:28:34 | OQ/PQ |
| 00:30:00 | PQ – Performance Qualification |
| 00:30:39 | What makes the first stage of the PQ difficult to perform? |
| 00:31:59 | What characteristics of the material should be modeled? |
| 00:33:05 | Standard Materials for verification in particle size analysis |
| 00:34:31 | Primary verification |
| 00:35:29 | Historical: reticle - basis of ASTM E1458 - 92 |
| 00:36:05 | Repeatability/reproducibility - reticle |
| 00:36:19 | Hardware onlyReticle – ASTM E1458-92 |
| 00:37:10 | ISO Guides |
| 00:37:55 | Thermo Scientific |
| 00:38:17 | Whitehouse Scientific |
| 00:38:43 | LatexLatices |
| 00:39:10 | Latex - examples |
| 00:39:52 | Stable samples |
| 00:40:24 | Stable samples |
| 00:40:49 | Why are 3 latex materials sufficient to prove the instrument optics? |
| 00:41:49 | MS2000 Data Point |
| 00:42:00 | Why don’t latices challenge sample dispersion units? |
| 00:42:29 | PQ – Performance Qualification - Second Stage |
| 00:42:56 | Secondary verification – PQ really |
| 00:43:35 | Internal standards |
| 00:44:01 | QAS |
| 00:44:23 | QAS – instrument verification |
| 00:44:36 | QAS/latex – instrument verification |
| 00:45:12 | QAS and latex – instrument verification |
| 00:45:19 | Malvern engineers are trained in this |
| 00:45:43 | What do I do in the event of a failure? How much can you afford to lose? |
| 00:46:42 | Design of ExperimentLogical Method Development |
| 00:47:17 | Software verification/21 CFR 11 |
| 00:47:39 | 21 CFR 11 http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm |
| 00:47:56 | 21 CFR 11 http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm |
| 00:48:29 | 21 CFR 11 http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm |
| 00:48:55 | 21 CFR 11 http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm |
| 00:49:22 | TickIT |
| 00:50:01 | Laser diffraction verification – ISO 13320:2009 |
| 00:50:44 | Laser diffraction verification – USP <429> |
| 00:51:17 | Previous relevant webinars |
| 00:51:49 | Kiitos ja kysymykset |
| 00:52:15 | Contact Information |
| 00:53:42 | Contact Information |
This webinar deals with the routes of verifying laser diffraction instrument performance dealing with the optical set-up, software, and dispersion units.
Who should attend?
Anyone involved in the verification of laser diffraction equipment. This could include quality control personnel, service engineers, applications engineers but most important, senior management especially director level, who are solely and ultimately responsible for the level of quality and performance within their organizations.