Statistics in pharmacy - life cycle of validation according to Annex 15

Dr. Marek Skow­ro­nek, Stat­Soft Pol­ska

The scope of the trai­ning covers the gui­dance in Annex 15 on the life cycle approach to vali­da­ti­on, with an empha­sis on the use of sta­tis­ti­cal methods for data ana­ly­sis. The cour­se com­bi­nes prac­ti­cal know­ledge on topics spe­ci­fic to the phar­maceu­ti­cal indus­try with know­ledge of data ana­ly­sis methods pre­sen­ted on the basis of data from this indus­try. Indi­vi­du­al sta­tis­ti­cal ques­ti­ons are first dis­cus­sed theo­re­ti­cal­ly and then deve­lo­ped in the form of exer­ci­s­es.

For whom?
For anyo­ne respon­si­ble for pro­cess vali­da­ti­on. We invi­te you if you do not yet know any­thing about data ana­ly­sis and sta­tis­tics for tech­no­lo­gi­cal pro­cess vali­da­ti­on. Like­wi­se, if you would like to refresh and deepen your know­ledge. Even if you alre­a­dy know the sta­tis­tics, but need a tool with which you can car­ry out your ana­ly­ses quick­ly and easi­ly. This trai­ning is the basis on which you can expand your know­ledge and skills in data ana­ly­sis.

Your advan­ta­ges:

    • You will get to know or sys­te­ma­ti­ze the basic con­cepts of sta­tis­ti­cal data ana­ly­sis,
    • You will go through the pha­ses of tech­no­lo­gi­cal pro­cess vali­da­ti­on yours­elf,
    • You will learn about nume­ri­cal and gra­phi­cal methods of data ana­ly­sis and traps that await the pro­cess engi­neer,
    • You will learn about sel­ec­ted topics of pro­cess sta­bi­li­ty and capa­bi­li­ty assess­ment,
    • You will recei­ve prac­ti­cal tips on how to avo­id errors in data ana­ly­sis and inter­pre­ta­ti­on,
    • You will acqui­re the basis for deve­lo­ping ana­ly­ti­cal skills and
    • You will learn how to plan the sta­tis­ti­cal con­trol of the tech­no­lo­gi­cal pro­cess

Trai­ning con­tent:

1. Intro­duc­tion

    • What is the modern defi­ni­ti­on of qua­li­ty?
    • What are the basic requi­re­ments for imple­men­ting the vali­da­ti­on life cycle?
    • What are the con­di­ti­ons and cri­te­ria for the tran­si­ti­on bet­ween vali­da­ti­on life cycle pha­ses?
    • What product/process para­me­ters need to be included in the sta­tis­ti­cal pro­cess con­trol pro­gram?
    • What is the typi­cal test plan for pro­cess vali­da­ti­on / ongo­ing pro­cess veri­fi­ca­ti­on?
    • How do I deal with dif­fi­cult cases of unsta­ble and / or inca­pa­ble pro­ces­ses?
    • How are OOT results reco­gni­zed during ongo­ing pro­cess veri­fi­ca­ti­on?
    • How to imple­ment the prin­ci­ple of con­ti­nuous impro­ve­ment based on sta­tis­ti­cal ana­ly­sis results?

2. Popu­la­ti­on and sam­pling

    • What is a popu­la­ti­on / ran­dom sam­ple?
    • What are the cha­rac­te­ristics of the gene­ral popu­la­ti­on / ran­dom sam­ple?
    • What are the sam­pling errors and how can they be con­trol­led?
    • What types of samples are the­re?
    • Exer­ci­s­es and examp­les of sam­pling.

3. Sta­tis­ti­cal descrip­ti­on

    • What is the avera­ge value of the data set?
    • What is the disper­si­on of the data set?
    • Whe­ther the dis­tri­bu­ti­on is uni­mo­dal or mul­ti­mo­dal?
    • Whe­ther the dis­tri­bu­ti­on is sym­me­tri­cal or asym­me­tri­cal?
    • Are the­re out­liers / extre­me values?
    • What is the con­fi­dence / pre­dic­tion inter­val?
    • Exer­ci­s­es and examp­les for describ­ing sta­tis­ti­cal data

4. Ana­ly­sis of pro­cess sta­bi­li­ty

    • What is the pur­po­se of pro­cess sta­bi­li­ty ana­ly­sis?
    • What is the dif­fe­rence bet­ween spe­cial and com­mon cau­ses?
    • What is the dif­fe­rence bet­ween the first type defect and the second type defect?
    • Which con­trol charts should be used for pro­cess sta­bi­li­ty ana­ly­sis
    • What are the basic prin­ci­ples for using con­trol charts?
      What are the pro­cess sta­bi­li­ty cri­te­ria?
    • When and which addi­tio­nal con­fi­gu­ra­ti­on tests should be used?
    • How are con­trol limits set for ongo­ing pro­cess moni­to­ring?
    • In which cases should the set con­trol limits be chan­ged?
    • When is a chan­ge to the limits jus­ti­fied?
    • What if the points are out­side the con­trol limits?
    • What if the data has a dif­fe­rent dis­tri­bu­ti­on than nor­mal?
    • Exer­ci­s­es and examp­les for pro­cess sta­bi­li­ty ana­ly­sis

5. Ana­ly­sis of pro­cess capa­bi­li­ty

    • What is the pur­po­se of pro­cess capa­bi­li­ty ana­ly­sis?
      What are the basic prin­ci­ples of pro­cess capa­bi­li­ty ana­ly­sis?
    • How are basic pro­cess capa­bi­li­ty indi­ca­tors deter­mi­ned?
    • What is the dif­fe­rence bet­ween Cp / Cpk and Pp / Pk indi­ca­tors?
    • What requi­re­ments must be met for capa­ci­ty indi­ca­tors to be relia­ble?
    • What mista­kes can be made when deter­mi­ning pro­cess capa­bi­li­ty indi­ca­tors?
    • When can a pro­cess be con­side­red pre­dic­ta­ble and ful­fill the accep­tance cri­te­ria?
    • How can a pro­cess be cate­go­ri­zed based on sta­tis­ti­cal ana­ly­sis results?
    • What mea­su­res should be taken for unsta­ble and/or inca­pa­ble pro­ces­ses?
    • Exer­ci­s­es and examp­les of pro­cess capa­bi­li­ty ana­ly­sis.

The lec­tu­re will be held in Eng­lish. The trai­ning docu­men­ta­ti­on will all be in Eng­lish. All par­ti­ci­pan­ts will recei­ve a prin­ted ver­si­on of the docu­men­ta­ti­on for per­so­nal use only.

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