m01[basic principles of gmp 1]
TRANSCRIPT
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Module 1 Slide 1 of 16 WHO - EDM
Introduction
to the TrainingCourse
Basic Principles of GMP
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Module 1 Slide 2 of 16 WHO - EDM
Introduction
Objectives of this IntroductorySession
To outline the programme To introduce your trainers
To introduce you to one another and tounderstand your objectives and background
To understand the way these modules work
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Module 1 Slide 3 of 16 WHO - EDM
Introduction
Programme Overview – I
Basic Principles of !P
1. Introduction to the training programme
2. Quality Management
3. anitation and hygiene
!. "alidation
#. $omplaints and recalls
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Module 1 Slide 4 of 16 WHO - EDM
Introduction
Programme Overview – II
Basic Principles of !P
%. $ontract production and analysis
&. el' Inspection
(. )ersonnel
*. )remises
1+. ,-uipment
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Module 1 Slide 5 of 16 WHO - EDM
Introduction
Programme Overview – III
Basic Principles of !P
11. Materials
12. ocumentation
13. terile production
1!. /ctive pharmaceutical ingredients
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Module 1 Slide 6 of 16 WHO - EDM
Introduction
Programme Overview – I"
!P Inspection Process
1#. Introduction
1%. The role o' the inspector
1&. )reparation 'or the inspection
1(. Types o' 0M) inspection
1*. The inspection
2+. Trainers notes
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Module 1 Slide 7 of 16 WHO - EDM
Introduction
#our Team
$ho are we%
Trainers
(Name)
(Qualications)
(Experience)
(Name)
(Qualications) (Experience)
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Module 1 Slide 8 of 16 WHO - EDM
Introduction
$ho am I%
ame
,perience 4bjectives
ot a lot o' people know555..
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Module 1 Slide 9 of 16 WHO - EDM
Introduction
Objectives of the training course
To introduce general elements on -ualitymanagement
To train you in the 674 0M) tets 'or
pharmaceutical products
To bring in your own eperience
To develop your own action plan
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Module 1 Slide 10 of 16 WHO - EDM
Introduction
Our $ay of $or&ing
/ presentation on the subject o' the module 8usually no
more than %+ minutes
follows the W! text as the "asis of the module
will ha#e the W! reference at the "ottom of the
slide
/ 3+8%+ minutes group session discussing issues or
a problem that will be set 'or you 0roup 'eedback in plenary session
Multiple choice -ui9
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Module 1 Slide 11 of 16 WHO - EDM
Introduction
'ow the roup Session and (eedbac& wor&s Move to your area and select a group chairperson: a
timekeeper: a recorder and reporter to present thegroups views to the combined meeting
Identi'y the issues to be discussed. iscussion;
fundamental to the learnin$ process
need enthusiastic participation
needs a %"rainstormin$ approach&
ocument the groups views on 1
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Module 1 Slide 12 of 16 WHO - EDM
Introduction
$or&ing in roups
)lease accept shared responsibility in each group 'or;
ialogue
hared ideas
hared understanding
hared meaning
$lari'ying
)articipation
,nabling others toparticipate
/ctive listening
/greeing to disagree
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Module 1 Slide 13 of 16 WHO - EDM
Introduction
$or&ing in roups6hen someone says something which does not agreewith your views: 5.
or seems wrong to you.5
o not immediately say='hats wron$& or %ow stupid&
)ause> ?e
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Module 1 Slide 14 of 16 WHO - EDM
Introduction
roup Sessioniscuss the 0M) issues you each 'ace in your own
countries
Identi'y key objectives to be achieved in attending
this programme at; a ?egional level
ational level
4rganisational level
)ersonal level.
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Module 1 Slide 15 of 16 WHO - EDM
Introduction
roup Session Identi'y key objectives to be achieved in attending this
programme: at a ?egional level: at a ational level: at an4rganisation level and at a personal level.
et objectives using the S!)*T 'ormula;
SpeciBc !easurable )ction8oriented
*ealisticTime8related
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Module 1 Slide 16 of 16 WHO - EDM
Introduction
roup Session Identi'y key objectives to be achieved in attending this
programme: at a ?egional level: at a ational level: at an
4rganisation level and at a )ersonal level.
4bjectives should be developed in the S!)*T 'ormat;SpeciBc: !easurable: )ction8oriented: *ealistic: Time8related
Identi'y 3 success criteria by which the objective will be
measured.
)lease observe the times allowed; - hour maximum discussion . / -0 minutes maximum feed"ac, for each $roup