7/21/2019 Pham 1123

http://slidepdf.com/reader/full/pham-1123 1/5

SECTION 1: MODULE SPECIFICATIONS

1. Title of the module

PHAM 1123 -GxP (Business Opi!n"

2. School which will be responsible for management of the module

Me#$%& S'!!) !* P%+,%'&

3. Start date of the module

  213

4. The cohort of students (onwards) to which the module will be applicable

212

5. The number of students expected to tae the module

1-3 pe+ '!!+!. "odules to be withdrawn on the introduction of this proposed module and consultation with other 

rele#ant Schools and $aculties regarding the withdrawal

N.A

%. &e#el of the module (e.g. Certificate [C], Intermediate [I], Honours [H] or Postgraduate [M])

I

'. The number of credits which the module represents

1/ '+e#is

. hich term(s) the module is to be taught in (or other teaching pattern)

Te ,!#u)e is p%+ !* e F!un#%i!n De0+ee in App)ie# Bi!s'ien'e Te'n!)!0& $i' isein0 #e)ie+e# p+i,%+i)& +!u0 e-)e%+nin0 !n % p%+-i,e %sis !e+ +ee &e%+s

1*. +rere,uisite and co-re,uisite modules

N!ne

11. The programme(s) of stud to which the module contributes

F!un#%i!n De0+ee in App)ie# Bi!s'ien'e Te'n!)!0&

12. The intended sub/ect specific learning outcomes and0 as appropriate0 their relationship toprogramme learning outcomes

•

emonstrate an understanding of pharmaceuticalindustr x+ re,uirements (POs: A24A34 B134 B15)

• a#e the abilit to appl the rele#ant x+ legislation that is applicable to their own wor

en#ironment (POs: A24 A34 A64 A14 A114 B134 B174 B154 C214 C224 C274 D324 D33)

• e able to appl the rele#ant tools and techni,ues used in x+ ris based compliance to

a wor related acti#it0 producing a summar report and recommendations (POs: A24 A34A/4 A84 A64 A14 A114 B134 B174 B194 B154 C214 C224 C274 D284 D324 D33 )

• 6nderstand the role of audits in ,ualit management and carr out an internal compliance

audit in accordance with the legislati#e re,uirements (POs: A24 A34 A/4 A84 A64 A14A114 B134 B174 B194 B154 C214 C224 C274 D284 D324 D33)

• 7now how to complete a non-conformance in#estigation and de#iation report using the

appropriate in#estigation techni,ues (POs: A24 A34 A14 A114 B134 B174 B154 C27 )

7/21/2019 Pham 1123

http://slidepdf.com/reader/full/pham-1123 2/5

13. The intended generic learning outcomes and0 as appropriate0 their relationship to programmelearning outcomes

•  8n abilit to analse0 e#aluate and correctl interpret data (POs: A24 B174 B154 C214

C224 D264 D25)

•  8n abilit to present and communicate data (POs: D294 D28)

•  8n abilit to obtain and use information from a #ariet of sources as part of self-directed

learning (POs: D2/4 D324 D33)

• Time-management and organisational sills within the context of self-directed learning

(POs: D31-D33"

14. 8 snopsis of the curriculum

• asic 9ntroduction to x+

• ood &aborator +ractices (&+)

• ood "anufacturing +ractices ("+)

•

:easons for #alidation• ;on-<onformance in#estigations and :eporting

• ood 8septic +ractices (8+)

• ood <linical +ractices (<+)

• :is ased <ompliance

• =ualit 8udits

15. 9ndicati#e :eading &ist

ISBN nu,e+ Au!+ D%e Ti)e Pu)ise+  

%'*'53!%1* ":8 2**% :ules and uidance for+harmaceutical"anufacturers andistributors

+harmaceutical+ress

%'-1-%%151-1-

 8nna &unden 2**' The "+ andboo &unden->llow

1!. &earning and Teaching "ethods0 including the nature and number of contact hours and the totalstud hours which will be expected of students0 and how these relate to achie#ement of the

intended learning outcomes.A'ii& e-)e%+nin0 e-%'iiies.

P+%'i'%)s .!+;

%'iiies

MSCL .CAL

T!%)!u+s

Le%+nin0 Ou'!,es

Teaching 25 15 15 //  820 830 850 8%0 8'0 81*0 8110 130 140 1!010 <210 <220 <2402%0 320 33

+ri#ate stud 15 5 1* 3  820 830 850 8%0 8'0 81*0 8110 130 140 1!0

10 <210 <220 <2402%0 320 33

7/21/2019 Pham 1123

http://slidepdf.com/reader/full/pham-1123 3/5

or-basedexperience

!* 9  840 850 8%0 8'0 81*- 8120 1'0 10 <2*-<220 <240 2%0 3*-33

$ormalassessment

/

T!%) !u+s 1/

On)ine e-)e%+nin0  is intended to present the e information directl relating to the learningob/ecti#es.E-%'iiies4 p+%'i'%)s %n# $!+; %'iiies ser#e to reinforce material presented online and alsorelate directl to the learning ob/ecti#es. These are specificall based on enabling students to relatetheir theoretical nowledge to the practice of x+ in their own and other companies.MSCL ser#es to reinforce and support materials presented in the abo#e forms in the students? minds.The also form part of the self-directed learning for the student.P+i%e su#& encompasses the re#ising of all material presented in the abo#e #arious forms of teaching and learning0 together with the opportunit to explore and read more widel around specific

topics (this ma alread ha#e been suggested in the "S<& materials).

1%. 8ssessment details@ 8ssessment methods and how these relate to testing achie#ement of theintended learning outcomes.

Me!# !* %ssess,en

Le%+nin0 !u'!,es%ssesse# (POs < SSLOs"

ei0in0 Ou)ine #e%i)s

<ontinuousassessment (1)

 820 830 850 8%0 81*-8120 1301!0 1'0 10 <210 <220<240 2%0 320 33

2*A :is based compliancereport

<ontinuousassessment (2)

 820 830 850 8%0 81*-8120 1301!0 1'0 10 <210 <220<240 2%0 320 33

2*A x+ audit report

<ontinuousassessment (3)

 820 830 850 8%0 81*-8120 13-1!0 1'0 10 <210 <220<240 2%0 320 33

2*A ased on assessment of  m$olio entries.

<ontinuousassessment (4)

 8ll sub/ect specific learningoutcomes (SS&Bs)

4*A 4* minute "<= assessment

Te p%ss ,%+; *!+ is ,!#u)e is 7= Te %i, !* e %ssess,en is % e+e s!u)# e %ne>u%) %)%n'e e$een ?%pp)i'%i!n@ (ie +e*)e'i!n +e)%e# ! p+%'i'%).$!+; expe+ien'e" %n#

?e!+&@ (ie ex%,in%i!n"4 u % neie+ s!u)# en%)e e su#en ! !%in % p%ss 0+%#ein#epen#en)& %n# in is eni+e&

1'. 9mplications for learning resources0 including staff0 librar0 9T and space

Te p+!0+%,,e $i)) e #e)ie+e# usin0 M!!#)e %s % i+u%) Le%+nin0 Eni+!n,en (LE"%n# ,&F!)i! $i)) e use# ! !)# %)) e*)e'ie P!+*!)i! en+ies %n# Pe+s!n%) Dee)!p,enP)%ns

15 The School recognises and has embedded the expectations of current disabilit e,ualitlegislation0 and supports students with a declared disabilit or special educational need in itsteaching. ithin this module we will mae reasonable ad/ustments where#er necessar0 includingadditional or substitute materials0 teaching modes or assessment methods for students who ha#edeclared and discussed their learning support needs. 8rrangements for students with declared

7/21/2019 Pham 1123

http://slidepdf.com/reader/full/pham-1123 4/5

disabilities will be made on an indi#idual basis0 in consultation with the 6ni#ersit?sdisabilitdslexia support ser#ice0 and specialist support will be pro#ided where needed.

If the module is part of a programme in a Partner College or Validated Institution, pleasecomplete the following:

2 +artner <ollegeCalidated 9nstitution@ N.A

21. 6ni#ersit School (for cognate programmes) or $acult (for non-cognate programmes)responsible for the programme@

SECTION 2: MODULE IS PAT OF A POGAMME OF STUD IN A UNIESIT SCHOOL

S%e,en & e S'!!) Di+e'!+ !* Le%+nin0 %n# Te%'in0.S'!!) Di+e'!+ !* G+%#u%eSu#ies (%s %pp+!p+i%e": D9 confirm 9 ha#e been consulted on the abo#e module proposal and ha#egi#en ad#ice on the correct procedures and re,uired content of module proposalsD

B8pampa

irector of &earning and Teaching

r uge 8pampa

+rint ;ame

ate

S%e,en & e He%# !* S'!!): D9 confirm that the School has appro#ed the introduction of themodule and0 where the module is proposed b School staff0 will be responsible for its resourcingD

ead of School

+rofessor 9ain <umming

+rint ;ame

ate Bctober 2*11

7/21/2019 Pham 1123

http://slidepdf.com/reader/full/pham-1123 5/5