Overview: The Modules: Module Description No. Manager: Check (X) If Relevant For New Employee

Novo Nordisk A/S
Recommended
timing:
Overview: The Modules Manager checks
off relevant
courses 2-3
weeks before QRP
starts
Manager: check [x] if

Module
Module Description relevant for new
No.
employee
1 General Introduction to Novo Nordisk and Quality

Week 1-2
2 Nonconformity Handling / Remarks / Internal Complaints
3 Handling of Finished Products (incl. release/return/reject products & handling transport deviations
4 Change Control
Week 3-4
5 Potential Recalls
6 QBIQ administration / ISOtrain Training Coordinator
7 Repackaging Marketed Products
8 Contracts & Quality Agreements

Week 5-6
9 Promotional Material
10 Archiving / Records Management
11 Basic QRP Intro: Clinical Trials and -Products*
12 Monitor & Interpret External / Local Requirements
13 Sample Handling
Week 7-8
14 GxP IT systems
15 Basic QRP Intro: Pharmacovigilance / Customer Complaints / Safety Reporting*
16 Qualification & Validation of Cold Storage Facilities

1 Year
17 Audits
18 Inspections
Just in Time
19 SOP writing / -support / -approval (Document Control)
20 Quality Management Review
* Usually not handled by QRPs

Please mail QAMSUPPORT regarding feedback and need for update
Page 1 of 26
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Recommended
timing:
Manager & QRP
Evaluation Form: Follow-up Meetings decide on
frequency of
This evaluation form can be used for documenting the evaluation of the training
follow-up meetings
during the first 2 months or for a longer period if needed. It is recommended to in week 1
have follow-up meetings with the QRP at least on day 30, 60, 90, and 120 after
the QRP starts.
Name Initials: Start date:
Employee:
Manager: N/A
Employee: Manager:
No. Comments
(date/sign) (date/sign)
The employee has finalished the following modules:
Training outstandings:
1
2
Follow-up
3
4
Page 2 of 26
Version: 3.0
Novo Nordisk A/S
BACK to overview
BACK TO OVERVIEW
Recommended
Module 1: General Introduction and to Novo Nordisk and the timing:
Week 1-2
Quality Organisation
QBIQ / ISOtrain / Signed in system

Training Method Description
LearnIT no. (Check mark [√] ):
Business Ethics
192727
(Choose relevant language version)
127938 IT code of conduct
Reporting of Safety Information
128074
(Or choose the country-related SOP)
Corporate SOPs
166087 Novo Nordisk Quality Manual
Mandatory Corporate Training
054929 Good Documentation Practice
194945 Quality Management in Operations
First work day : GlobeShare > Organisation > Corporate

First day Development > Corporate People & Organisation >
Courses Onboarding requirements (iNNtro) > iNNtro > Post Start
As soon as QAM Introductory QA course (Thorough 1:1 training or
possible similar quality experience can replace the course)
Portal2People (if UserAR2 > SAP ECC (E1P) > portal2people > Affiliates > ESS Employee self
applicable) serviceGlobal > ESS role for regular employee > HPortal ESS Employee Global
IT System 3P UserAR2 > System Roles > 3P User

Access
Skype for Business UserAR2 > Skype for business > Skype Enterprise CAL
Write "Quality" in the browser to access the Quality processes

More info
Write "QAM" in the browser to access QAM's site and Quality portal

LearnIT no. (Check mark [√] ) :
Local/Cross-
Unit/Unit SOPs /
Legislations
Local Courses
Trained with trainer
Suggestions for training: (Check mark [√] ):
Introduction: How-to use this training plan
Customized Local Training
Meet your buddy: ____[initials]___
About Novo Nordisk, The Qualilty Organisation and the Affiliate*

Meet with: Diabetes/Biopharm/Finance/Safety/Regulatory/Medical/GM
Introduction to Novo Nordisk Products handled in the affiliate
Intro to Performance Management (3P) and Individual Development Plan
(IDP)
1:1 training Setup 1:1 plan with manager in the calendars
Intro to IT systems (Intranet, Portal2People, ISOtrain, Shared Drives,
UserAR2, LearnIt, Concur, Skype)
Job description & CV
The Quality Management System (QMS)*
The Process Landscape (QBIQ)*
Intro to QAMSUPPORT Mailbox (remember to write QAM mailbox for adding
new QRPs to the mail list)*
Intro to Local Quality KPIs & Balance Score Card (BSC)
*) Part of presentation that can be found on QAM's Quality Portal under "About QAM"
Page 3 of 26
Version: 3.0
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BACK TO OVERVIEW
Recommended
timing:
Module 2: Nonconformity Handling / Remarks / Internal Week 1-2
Complaints

Handling Nonconformities in Regions outside

118627
novoGloW (relevant for non-novoGlow users)
Corporate SOPs
019467 Nonconformities (relevant for novoGloW users)
novoGloW System Overview & Navigation

66756
(relevant for novoGloW users)
Views, Advanced Search & Reports (relevant for

67393
novoGloW users)
Mandatory Global Training
Nonconformity Process Overview (relevant for

E-Learnings 75385
novoGloW users)
SPS/ Root Cause Analysis (relevant for novoGloW

94785
users)
Linking to the Novo Nordisk processes (relevant

83004
for NC QA or NC SME user)
Nonconformity training NN-NC-CLASSROOM-1
75383
(See alternative in 1:1 training)
Nonconformity QA Approval (relevant for QA
94787
Courses approving novoGloW users)
Change Owner, QA and CR Expert Affiliates
95845 (applicable for Change Control - relevant for QA
approving novoGloW users)
IT System novoGloW (if UserAR2 > novoGloW > Production > Nonconformity > choose your
Access applicable) applicable role(s)
Type "nonconformity" in your browser > Training folder > Overview of training > Training
More info
Need Assessment Tool

Local/Cross-
Unit/Unit SOPs /
Legislations
Local Courses

Suggestions for training & Mandatory training: (Check mark [√]):
Mandatory training (Alternative to L75383 in order to get

novoGloW system access):
1:1 training with local NC SME is only mandatory if it is a
replacement for course 75383: (See scope for 1:1 training in 81451
NN-NC-QA-JTP on GlobeShare under "more info" link)
- Go through all parts of a Closed NC,
NC no.: ________________
- See example of how to QA conclude on a NC,
NC no.: ________________
1:1 Training - Review and conclude on minimum 3 NCs,
NC no.: ________________
NC no.: ________________
NC no.: ________________
- Go through all parts of a Closed Planned NC,
NC no.: ________________
Registration: Local NC SME must contact the HQ NC Expert for the
training registration.
Suggestion: Go through Root Cause Analysis in a nonconformity
Suggestion: Go through examples of differences between

nonconformities, remarks, and internal complaints
Page 4 of 26
Version: 3.0
Novo Nordisk A/S
BACK TO OVERVIEW
Recommended
timing:
Module 3: Handling of Finished Products (incl. release/ Week 3-4
return/reject products & handling transport deviations)

LearnIT no. (Check mark [√] )
How to handle, transport, store and distribute Novo Signed in system
040747
Nordisk products (Check mark [√] )
121545 Storage and Distribution in Regions
Novo Nordisk product requirements for transport
Corporate SOPs 170336 from production site to contract acceptor (distribution
partner)
188212 How to report transport and storage deviations in IMS
E-Learnings N/A N/A N/A
Courses N/A N/A
TTC Web
TempTracer For access: Contact TMD-Support@novonordisk.com
IT System system
Access Before requesting access, send a screen dump of your training from this module's
IMS corporate ISOtrain training to mailgroup: SHIPCU@novonordisk.com
Request access: UserAR2 > IMS
Go to GlobeShare > Systems & Services > TempTracer system or search for "TMD" on GlobeShare to
More info
find information about the TempTracer System. Here you find user guides and quick guides.

Local/Cross-
Unit/Unit SOPs /
Legislations
Local Courses

Suggestions for training: (Check mark [√]):
Go through procedures for release/return/reject products & destruction

handling
1:1 Training
Tour in warehouse / at distribution partner / consignment stock
Page 5 of 26
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BACK TO OVERVIEW
Recommended
timing:
Module 7: Repackaging Marketed Products Week 3-4

Corporate SOPs 015617 Repackaging of Marketed Novo Nordisk Products
Courses N/A N/A N/A
IT System
N/A N/A
Access
More info Type "QAM" in your browser and from there go to QAM's Quality Portal

Local/Cross-
Unit/Unit SOPs /
Legislations
Local Courses

Suggestions for training:
(Check mark [√]):
1:1 Training Before making the first re-packaging plan, the person should be trained
in a previous approved re-packaging plan and batch documentation.
Page 6 of 26
Version: 3.0
Novo Nordisk A/S
BACK TO OVERVIEW
Recommended
timing:
Module 4: Change Control Week 3-4

Corporate SOPs 184290 Change Control in Regions and Affiliates
66755 Change Control process

67393 Views, Advanced Search and Reports
E-Learnings 66756 System overview and navigation
39969 Change Control focusing on the QA role *)
83004 Linking to the Novo Nordisk processes
Courses 95845 Change Owner, QA and CR Expert Affiliates
IT System UserAR2 > novoGloW > Production > Change control > choose your applicable
novoGlow
Access role(s)
Type "changecontrol" in your browser > Training folder > Overview of training > Training Need
More info
Assessment Tool

Local/Cross-
Unit/Unit SOPs /
Legislations
Local Courses

(Check mark [√]):
*) Pre-requisite for course 39969: Course participants must be trained
1:1 Training locally and have gone through a few change request cases together with a
local QA before the course
Page 7 of 26
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BACK TO OVERVIEW
Recommended
timing:
Module 5: Potential Recalls Week 3-4

Corporate SOPs 011411 Handling Potential and Actual Recalls
Courses N/A N/A N/A
IT System
N/A N/A
Access
Search for "Global Safety" to enter site - Go to Potential Recalls

More info See video to support training in Q011411 “Handling Potential and Actual Recall”; type
"novotube" in browser, search for "potential recall"

Local/Cross- Affiliate must have a local SOP
Unit/Unit SOPs /
Legislations
Local Courses

Suggestions for training: (Check mark [√]):
Go through local potential recall SOP and ensure understanding of
1:1 Training procedures in a recall situation.
Go through example of Significant Product Defects
Page 8 of 26
Version: 3.0
Novo Nordisk A/S
BACK TO OVERVIEW
Recommended
timing:
Module 6: QBIQ administration / ISOtrain Training Week 3-4
Coordinator
This training module covers more roles (QBIQ administrator, ISOtrain training coordinator)

165488 QBIQ Administration

Corporate SOP
100084 Document Control of QBIQ Documents
Courses L3651 QBIQ Administrator
QBIQ UserAR2 > QBIQ Administration module > QBIQ administrator > QBIQ list >
IT System Administrator choose your applicable QBIQ list and site
Access ISOtrain Training UserAR2 > ISOtrain > 1 Training Coordinator > choose your applicable area /
Coordinator site
Type "QBIQADM" in your browser to enter information on QBIQ administrator course.

More info
Type "TDM" in you browser to enter information on ISOtrain courses

Local/Cross-
Unit/Unit SOPs /
Legislations
Local Courses

Suggestions for training & Mandatory training:
(Check mark [√]):
Mandatory (according to QBIQ 102270):

The local ISOtrain site super user or ISOtrain Functional Support must train
a person to become an ISOtrain training coordinator
1:1 Training
Suggestion: Go through procedures for navigation, search document, create
document, import document, sign and approve document in novoDOCS.
Suggestion: Go through QBIQ administrator responsibilities with a QBIQ

administrator
Page 9 of 26
Version: 3.0
Novo Nordisk A/S
BACK TO OVERVIEW
Recommended
timing:
Module 8: Contracts / Quality Agreements Week 5-6

How to prepare a quality agreement between distribution
173068
Corporate SOPs partners and Novo Nordisk
116678 Managing Contracts in Novo Nordisk
UserAR2 > Contract Management > choose access type with your NN domain >
request the General User access (basic access)
Courses CMS
UserAR2 > Contract Management > choose access type with your NN domain >
Contract Initiator
IT System
Type "CMS" in your browser to see more about training, acccess, users guides etc.
Access
More info Type "QAM" in your browser and from there go to QAM's Quality Portal where you can find more on
Contract & Quality Agreements

Local/Cross-
Unit/Unit SOPs /
Legislations
Local Courses

Suggestions for training & Mandatory training (alternative):
(Check mark [√]):
Suggestion: Go through templates (QBIQ173068) and an existing Contract

and Quality Agreement
Mandatory (According to CMS system site, see "More info" above):

In order to get access to CMS, users must receive training from a local CMS
1:1 Training Super User (or see alternative below)
Mandatory (As alternative to mandatory CMS Super User training): Read
the user guides and take the e-learnings (find these in links from "more
info" above.
Page 10 of 26
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Novo Nordisk A/S
BACK TO OVERVIEW
Recommended
timing:
Module 9: Promotional Material Week 5-6

Approval of promotional material in Novo Nordisk

Corporate SOPs 100965
(relevant if QRP acts as Author for Local SOP)
Courses N/A N/A
IT System System Access (relevant for Zinc users)

Zinc (if applicable)
Access Read SOPs about Zinc (contact the super user in your area)
Type "zinc" in your browser

More info
Search for "zinc support" on GlobeShare

Local/Cross- Affiliate must have a local SOP
Unit/Unit SOPs /
Legislations
Local Courses

(Check mark [√]):
Go through different types of promotional material (Paper-based and web
pages)
1:1 Training
Go through requirements for approval of promotional material (e.g. version
control, approval flow)
Go through required local SOP on handling of promotional material
Page 11 of 26
Version: 3.0
Novo Nordisk A/S
BACK TO OVERVIEW
Recommended
timing:
Module 10: Archiving / Records Management Week 5-6

Records Management of business-critical of electronic
153763
records (relevant for system- and data owners)
Corporate SOPs
Records Management of business-critical physical
153016
information
E-Learnings 32108 Introduction to the Atlas system N/A
OmniRIM LRM training (only relevant for LRM or
32280 employees carrying out practical archiving). See
alternative to course in 1:1 training.
Local Records Manager: UserAR2 > omniRIM > User Roles > Local Records
IT System
OmniRIM Manager and other indexing employees (LRM) > select the relevant Key
Access
Business Process (You must be trained in 32108 and 32280 to get access)
Type "RMC" in your browser

More info Type "atlas"
Type "omnirim" in your browser (archiving system, access is required to enter)

Local/Cross-
Unit/Unit SOPs /
Legislations
Local Courses

Suggestions for training & Mandatory training (alternative):
(Check mark [√]):
Suggestion: Practical training in archiving procedures and show the local

archive
Suggestion: Go through examples of catalogues (atlas) and archiving in
omniRIM
1:1 Training
Mandatory (Alternative to course 32280): According to RMC
GlobeShare site (See "More info" above) omniRIM system access requires
training by local omniRIM Super User
Page 12 of 26
Version: 3.0
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BACK TO OVERVIEW
Recommended
timing:
Module 11: Basic QRP Intro: Clinical Trials and -Products Week 5-6
This module is only an introduction to QRPs. If any specific roles within the module areas,
please refer to training with Global Development.

042624 Handling of Trial Products in Clinical Trials
Local Depots: Contracting with Local Depots & Transfer

124586
and Destruction of Trial Products
Corporate SOPs
124055 Temperature Deviation Report Form
Transport and Storage of Trial Products at Local Depot in

124561
Clinical Trials
GlobeShare > Organisation > R&D > Global
Basic GCP E-
E-Learnings Development > People and Training > GD Course
Learning
Calendar - Basic GCP e-learning
Courses N/A N/A N/A
IT System
N/A N/A
Access
Training support mailbox: GTCG (Global Training Coordination Group)

GlobeShare > Organisation > R&D > R&D areas > CMC Supply > CMC Supply areas > CMC CS >
More info CS areas
GlobeShare > Organisation > R&D > R&D areas > CMC Supply > CMC Supply areas > CMC CS >
CS areas > CS Project Planning > IWRS Team

Local/Cross-
Unit/Unit SOPs /
Legislations
Local Courses

(Check mark [√]):
1:1 Training Give an overview of current clinical trials in the affiliate

Go through the QRP's role, if any, in the clinical trials
Page 13 of 26
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BACK TO OVERVIEW
Recommended
timing:
Module 12: Monitor & Interpret External / Local Week 7-8
Requirements

Corporate SOPs Q194945 Quality Management in Operations
Courses N/A N/A N/A
IT System
N/A N/A
Access
Q166087 (Novo Nordisk Quality Manual, Section 5.1)

More info
Type "extreq" > Training folder > Overview of training & Videos

Local/Cross-
Unit/Unit SOPs /
Legislations
Local Courses
Trained with
Suggestions for training: trainer (Check
mark [√]):
Intro to local GxP / Health Authority Requirements

1:1 Training
Go through requirements to the local unit in Section 5 "External

Requirements" in SOP 111939 Quality Management System Compliance
in Regions and how these requirements are implemented in the affiliate
Page 14 of 26
Version: 3.0
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BACK TO OVERVIEW
Recommended
timing:
Module 13: Sample Handling Week 7-8

Corporate SOPs 122788 Handling of Novo Nordisk Samples in Regions
Courses N/A N/A N/A
IT System
N/A N/A
Access
More info N/A

Local/Cross-
Unit/Unit SOPs /
Legislations
Local Courses

(Check mark [√]):
Examples of sample handling in an affiliate
1:1 Training
Page 15 of 26
Version: 3.0
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BACK TO OVERVIEW
Recommended
timing:
Module 14: GxP IT Systems Week 7-8
This module is only a basic introduction. Please go to the Complementary list of this training plan for
additional training within GxP IT Systems.

187218 Ownership of IT Systems and Data
Corporate SOPs Quality Management of Electronic Records and Electronic
005912
Signatures
Mandatory Corporate

Training
Courses N/A N/A N/A

IT System
N/A N/A
Access
Type "IT" in your browser and find the IT&Q Global Process portal
Type "rits" in your browser to find more training material
More info E-Learning Ownership of IT Systems and Data
E-Learning SIA – System Impact Assessment
E-Learning Quality Mgmt. Of ER and ES

Local/Cross-
Unit/Unit SOPs /
Legislations
Local Courses

(Check mark [√]):
Explain the definition of a GxP IT system versus non-GxP
1:1 Training
When and how validaton of IT is performed (GxP IT system versus non-GxP)
Go through local QRP's roles and responsibilities and, if relevant,

outsourcing of IT system validation activities
Page 16 of 26
Version: 3.0
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BACK TO OVERVIEW
Recommended
timing:
Module 15: Basic QRP Intro: Pharmacovigilance / Week 7-8
Customer Complaints / Safety Reporting

This module is only an introduction to QRPs. If any specific roles within the module areas,
please refer to training with Global Safety.

Handling of Adverse Events and Other Safety
014048
Information (Evaluate if SOP is only "Know")
Corporate SOPs
008782 Handling of customer complaints

Courses N/A N/A N/A
N/A N/A
IT System
Access
Argus UserAR2 > Argus Safety > Production > choose your affiliate/role
Type "gstraining" in your browser to learn more about Global Safety in affiliates
Type "argus" in your browser to access argus
More info
Remember to contact Global Safety for adding new QRPs working within this module and safety
reporting to the mail list

Affiliate must have local SOPs (Adverse Events,
Local/Cross-
Customer Complaints)
Unit/Unit SOPs /
Legislations
Local Courses

(Check mark [√]):
Give examples of the QRP's support or involvement in the
pharmacovigilance / Customer Complaints / Safety reporting
1:1 Training Go through required local SOP on Customer Complaints and required local
SOP on Adverse Events.
Go through Customer Contact Logging - Type CCSE in your browser
Go through CCSE - Customer Contact System Europe (European affiliates)
Page 17 of 26
Version: 3.0
Novo Nordisk A/S
BACK TO OVERVIEW
Recommended
timing:
Module 16: Qualification & Validation of Cold Week 7-8
Storage Facilities

019448 Validation
Metrology in Novo Nordisk

019466
(relevant if performing validation)
Validation of off-the-shelf cabinet refrigerators in NN
122470
(relevant if validating cabinet refrigerators)
Corporate SOPs
Validation of customised Cold Storage Facilities
185911
(relevant if validating customised cold storage rooms)
Calibrate measuring equipment (see form 184190)

179324
(relevant if checking measuring equipment)

Courses N/A N/A N/A
IT System
N/A
Access
Type "Quality" in your browser and go to:

- Validation process > Cold Storage
More info
- Metrology
Type "QAM" to enter QAM's Quality portal

Local/Cross-
Unit/Unit SOPs /
Legislations
Local Courses

(Check mark [√]):
Go through documentation of types of qualifications at the affiliate (for

1:1 Training example shipper boxes, cold storage room, validated trucks)
Tour in warehouse / at distribution partner / consignment stock
Page 18 of 26
Version: 3.0
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BACK TO OVERVIEW
Recommended
timing:
Module 17: Audits After 1 year

019473 Audits
Corporate SOPs
196161 Audits in Operations
75387 Audit & Inspection Process Overview

E-Learnings
novoGloW Action Approval user guide
169858
(mandatory for Finding & Action Approver)
L6281 QAM-LA & GDP Course (Lead auditor course)
Courses Alternative to
L6281 can be replaced by ISO-9001 Lead auditor course
L6281:
or similar course provided locally
ISO 9001 course
GlobeShare audit
IT Systems Contact QAMSUPPORT to get access to reporting site
reporting
Type "Audit" in your browser

More info
Type "QAM" and go to QAM's Quality Portal/Audit toolbox

Local/Cross-
Unit/Unit SOPs /
Legislations
Local Courses

Mandatory training to become a Lead Auditor
(Check mark [√]):
Attend as an audtior trainee in minimun 2 internal audits in the presence of
an experienced Lead Auditor (arrange with Lead Auditors):
Audit 1: Auditor trainee role
1:1 Training Audit 2: Lead Auditor role
Training to maintain lead auditor competencies
Go through an audit plan and the latest inspection report

Conduct min. 1 audit (internal/external) and stay updated on external requirements
Page 19 of 26
Version: 3.0
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BACK TO OVERVIEW
Recommended
timing:
Module 18: Inspections After 1 year

Q194945 Quality Management in Operations

Corporate SOPs
Q169237 Inspections form Health Authorities
E-Learnings 75387 Audit & Inspection Process Overview
Courses
IT Systems
Type "Inspection" in the browser

Type "QAM" - go the Quality Portal and look under Inspections; here you find:
More info
- Corporate Inspection Register
- CIR Manual

Local/Cross-
Unit/Unit SOPs /
Legislations
Local Courses

(Check mark [√]):
1:1 Training
Page 20 of 26
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BACK TO OVERVIEW
Recommended
timing:
Module 19: SOP writing / -support / -approval Just-in-time
training *)
(Document Control)
The role, Review Coordinator, must read corporate SOP (not Just-In-Time training for this role)

100084 Document Control of QBIQ Documents
Corporate SOPs 100086 Issue SOP in QBIQ

154605 Reviewing effective SOP
Abolish SOP in QBIQ
154603
78867 SOP template (mandatory if SOP author)
78914 Write Clear SOPs (mandatory if SOP author)

E-Learnings
78913 Document Control process (mandatory if SOP author)
83004 Linking to NN processes (SOP QA Approver)
Courses N/A N/A N/A
UserAR2 > novoDOCS > novoDOCS CORP > Author > Author > QBIQ CORP >
novoDOCS CORP
IT System QBIQ CORP > sub_auth_all_corp_users_qbiq
Access Install SOP
Type "sop" in your browser - Look for SOP template > Install the SOP template
template
Type "sop" in your browser
More info
Type"sopexpert" in your browser

Local/Cross-
Unit/Unit SOPs /
Legislations
Local Courses

(Check mark [√]):
1:1 Training Go through the SOP 7 template
Page 21 of 26
Version: 3.0
Novo Nordisk A/S
BACK TO OVERVIEW
Recommended
timing:
Module 20: Quality Management Review Just-in-time
training

Corporate SOPs 174889 Quality Management Review QMR
Courses N/A N/A N/A
IT System
N/A
Access
More info Type "qmr" in your browser.

Local/Cross-
Unit/Unit SOPs /
Legislations
Local Courses

(Check mark [√]):
1:1 Training Go through the lastest QMR
Go through the QMR templates
Page 22 of 26
Version: 3.0
Novo Nordisk A/S
Recommeded
timing:
Plan relevans
Complementary Training with your
manager
This is a list of complementary traning for introduction as well as senior training.
The QRP and the manager of the QRP must evaluate if more training than listed in the
modules are needed. The list is not exhaustive.
Manager: Relevant
Reference Description for new employee?
[x]
General Quality Training
Good Documentation Practice: GlobeShare > Novotube > search:

Video on Novotube
"Good Documentation Practice - get it right first time"
Type "Quality" > About QMS > Quality Manual, ISOtrain course:
E-learning
Q166087
Good Manufactoring Practice (Re-training, for example annually for

GMP re-training
relevant affiliates)
Course MS-R301 Good Documentation Practice for new employees
Potential Recalls
Course, 73778 Handling of Potential Recalls and Actual Recalls

Course, L7884 Potential Recall Classroom Training: Potential Recall Coordinator
Handling finished Products (incl. Release/Return/Reject Products & Handling transport deviations)
The training listed below is extended QRP training to the module

SOP, QBIQ 008786 Returned goods
SOP, QBIQ 145509 Transport and Storage of Customer Complaint samples
QBIQ administration / ISOtrain Training Coordinator
Course 47074 novoDOCS R4 End-user course
Course 47074 novoDOCS R4 Super-user course
Type "arweb" in your browser (System for submission of system
ARWEB
issues or viewing cases created in Global Remedy)
Training material GlobeShare > Corporate Development > IT System Management >
novoDOCS Systems > novoDOCS > Training
Promotional Material
Certification of material generated in Marketing, Medical Affairs &

SOP, QBIQ 163204
Stakeholder Engagement via Zinc
Archiving / Records Management
Protecting and Handling Information: Go to GlobeShare > Novotube

Video on Novotube
> search: "Protecting and handling information"
ISOtrain course NN-RM-P-
Super User in OmniRIM (Please see pre-requisite up front)
SU
Monitor & Interpret External / Local Requirements
SOP, QBIQ 100158 RA-P-611E Contact with Regulatory Authorities
GxP IT Systems
If working with specific IT Systems activities, these SOPs must be evaluated for training.
SOP, QBIQ 187655 Manage IT Security

(Training not to be documented in ISOtrain)
SOP, QBIQ 187405 Specify User Requirements and Plan Implementation of IT Systems
SOP, QBIQ 187407 Manage Test & Qualification, Release and Operation of IT Systems
SOP, QBIQ 187408 Manage Configuration of IT Systems

SOP, QBIQ 187409 Manage Users of IT Systems

SOP, QBIQ 187406 Manage Design and Construction of IT Systems Software

Supplementary e-learning IT code of Conduct, ISOtrain course: 60225

Supplementary e-learning Ownership of IT Systems and Data
Supplementary e-learning Manage IT Systems v. 10.0
Page 23 of 26
Version: 3.0
Novo Nordisk A/S
Recommeded
timing:
Plan relevans
manager
Manager: Relevant
[x]
Basic QRP Intro: Pharmacovigilance / Customer Complaints / Safety Reporting

GlobeShare> Novotube > search: Living Up to the New EU
Video on Novotube
Pharmacovigilance Legislation
GlobeShare > Novo Nordisk Logo(upper left corner) > Novotube >
E-learnings
search: Launching GS training site for external stakeholders
Paper Booklet For Global Safety booklet, contact GStrainingQA@novonordisk.com
Course, 73777 Handling Customer Complaints
Course, 72404 Basic Introduction to Pharmacovigilance (PV)
Course, 78597 Regulatory Pharmacovigilance Requirements in the EU
Course 69861 Introduction to the Pharmacovigilance System Master File
SOP, QBIQ 159877 Conduct PV audit
Qualification & Validation of Cold Storage Facilities
Supporting guidance documents

QBIQ 115249 Qualification of Cabinet Refrigerators
Editable forms to QBIQ Installation, Operation, and Performance Qualification Protocol
115249 (including Validation Plan activities)
Editable forms to QBIQ
Periodic System Evaluation (PSE)
115249
Qualification Report (XQR)
115249
QBIQ 119132 Qualification of Cold Storage Rooms
Editable forms to QBIQ Installation, Operation, and Performance Qualification Protocol
119132 (including Validation Plan activities)
Periodic System Evaluation (PSE)
119132
Qualification Report (XQR)
119132
User requirement Specification (URS)
119132
QBIQ 123845 Basic Knowledge about Cold Storage Rooms
QBIQ 144045 Monitoring and Alarms in Cold Storage Facilities in Affiliates
Audit & Inspection
SOP, QBIQ 175088 Audits in novoGlow
SOP writing/-support/-approval (Document Control)
A) The first part of your training is to complete the module "SOP

writing / -support / -approval". This is the same training that SOP
Training to be SOP expert Authors receive. B) New global SOP expert training is available from
the end of 2015 (Go to: GlobeShare > Write "sop" in your browser,
go to "Training"
SOP, QBIQ 156196 Issue SOP with External Partners

Basic QRP Intro: Clinical Trials and -Products
SOP, QBIQ 110008 Principles of Clinical Research
SOP, QBIQ 160106 Clinical nonconformities in novoGloW
Clinical nonconformity Owner & QA Approver
(Only for clinical nonconformity process roles – this course can
Course 79851
replace the ordinary nonconformity Owner & QA Approver class
room training, 75383 in Module 3)
Clinical Nonconformities add on slide package
(Only for clinical nonconformity process roles where employees are
Course 79543
trained in ordinary nonconformity Owner & QA Approver class room
training, 75383 in Module 3)
Modules with no complementary training
Nonconformity Handling / Remarks / Internal Complaints
Change Control
Repackaging Marketed Products
Contracts & Quality Agreements
Promotional Material
Page 24 of 26
Version: 3.0
Novo Nordisk A/S
Recommeded
timing:
Plan relevans
manager
Manager: Relevant
[x]
Sample Handling
Quality Management Review
Page 25 of 26
Version: 3.0
Novo Nordisk A/S
Change log
Version Initials Date Change Description
1.0 CATS 2015.12.11 New document.

2.0 ASKo 2016.09.07 General: Link to Affiliate Quality Portal updated
M1: "(Choose the country-related SOP)" added to Business Ethics,
Link to intro training updated, 171710 removed.
M2: Added QAMSUPPORT mailbox.
M3: Linking to the Novo Nordisk processes (relevant for NC QA or NC SME user).
M4: 040747, added "(only if local QM)", Link to Elpro Libero updated, added
188212 'How to report transport and storage deviations in IMS’
M5 Replaced 007532 with 184290. Added 70089, Revision Memo for QA,
replaced course 66268 with 66270.
M6: added link ti recall video
M9: 047893, Managing Consignment Stock and Customs Bonded Warehouse
Contracts removed, 053891, NNHCAG and NNFCAG Consignment contracts,
establishment and maintenance removed, Links to eLearning and user guides
updated.
M10: Added '(only relevant if QRP acts as Author for Local SOP)', Removed N/A
from L8404 training, Added 'Affiliate must have a local SOP' in Local training.
M11: Deleted 011863 and added 153763 Records Management of business-
critical of electronic records
M12: Removed link to novoGloW.
M13: Added 111939 Quality Management System Compliance in Regions as
mandatory traiing and removed same from 'More info'
M17: 122470, title updated, added 185911 Validation of customised Cold Storage
Facilities.
M18: Added QAPWeb responsible.
M19: Deleted 113506. Added 159875 "Conduct internal ISO/GMP, GDP and SKS
audit"
M20: Deleted 154603 and 156196. "Linking to Novo Nordisk processes (only
mandatory if SOP author)" changed to "Linking to NN processes(SOP QA
Approver)”
Complementory: Added 154603 "Abolish SOP in QBIQ" and 156196 "Issue SOP
3.0 DITW In general, all text
with External
in "More Info" have been simplified under all modules.
There are nowPartners". Deleted
19 modules course
instead of 21MS-R212,
. The intro"Record Management
modules have mergedof and
Physical information" and NN-RM-E-NOVODOCS "Archiving in NovoDocs"
the QAP module has been removed as the process is no longer mandatory.
Intro modulel: Q107878 Business Ethics replaced with new BE 192727. 59008
on Business Ethics removed
Quality Training: 111939 replaced with new SOP: Q194445 - GlobeShare path
shortened - It has been added that you can write "QAM" in the brower to access
the portal
NC Handling: Major changes conducted; Training curicullum adjusted to new
training set-up/assessment tool developed by process experts. Additional training
curriculum removed.
Handling Finished products: 3 SOPs removed: Q103754; Q119070; Q162649
E-lerning on "Sending Sites" removed - Path to E-learning of "Receiving Sites"
updated - IT System "TRPS" changed to "IMS". Link to Elpro Libero removed.
Change control: Major changes conducted; Training curicullum adjusted to new
training set-up/assessment tool developed by process experts. Additional training
2017.03.07 curriculum removed. Following e-learnings have been removed: 67392, 70089,
66270. E-learning 95845 has been added.
Promotional Material:LearnIt course removed
Contract/Quality Agreements: Q053891 removed
Archiving: Q128427 has been abolished. E-learning course added.
Clinical Trials and -Products: Q124055 has been added
Monitor & Interpret External Requirements: Q111939 replaced with
Q194945
GxP Systems: SOPs changed to:
- 187218 Ownership of IT Systems and Data
- 005912 Quality Management of Electronic Records and Electronic Signatures
Complementary curriculum changed to reflect new structure
QBIQ: Q102270 removed as the SOP has been abolished
rits and e-learning added
Qualification and validation of cold storage: Link to Global Remedy removed
and SOP 124383 replaced by SOP 179224
Audit and Inspections module is split into two; New Audit procedure included.
2017.07.07
Page 26 of 26
Version: 3.0

Overview: The Modules: Module Description No. Manager: Check (X) If Relevant For New Employee

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Overview: The Modules: Module Description No. Manager: Check (X) If Relevant For New Employee

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Novo Nordisk A/S

Manager: check [x] if

1 General Introduction to Novo Nordisk and Quality

2 Nonconformity Handling / Remarks / Internal Complaints

6 QBIQ administration / ISOtrain Training Coordinator

7 Repackaging Marketed Products

8 Contracts & Quality Agreements

10 Archiving / Records Management

11 Basic QRP Intro: Clinical Trials and -Products*

12 Monitor & Interpret External / Local Requirements

15 Basic QRP Intro: Pharmacovigilance / Customer Complaints / Safety Reporting*

16 Qualification & Validation of Cold Storage Facilities

19 SOP writing / -support / -approval (Document Control)

20 Quality Management Review

* Usually not handled by QRPs

Name Initials: Start date:

The employee has finalished the following modules:

The employee has finalished the following modules:

The employee has finalished the following modules:

QBIQ / ISOtrain / Signed in system

054929 Good Documentation Practice

194945 Quality Management in Operations

First work day : GlobeShare > Organisation > Corporate

IT System 3P UserAR2 > System Roles > 3P User

Write "Quality" in the browser to access the Quality processes

QBIQ / ISOtrain / Signed in system

Meet your buddy: ____[initials]___

About Novo Nordisk, The Qualilty Organisation and the Affiliate*

Intro to Local Quality KPIs & Balance Score Card (BSC)

QBIQ / ISOtrain / Signed in system

Handling Nonconformities in Regions outside

novoGloW System Overview & Navigation

Views, Advanced Search & Reports (relevant for

Nonconformity Process Overview (relevant for

SPS/ Root Cause Analysis (relevant for novoGloW

Linking to the Novo Nordisk processes (relevant

QBIQ / ISOtrain / Signed in system

Trained with trainer

Mandatory training (Alternative to L75383 in order to get

Suggestion: Go through Root Cause Analysis in a nonconformity

Suggestion: Go through examples of differences between

return/reject products & handling transport deviations)

QBIQ / ISOtrain / Signed in system

188212 How to report transport and storage deviations in IMS

E-Learnings N/A N/A N/A

Courses N/A N/A

QBIQ / ISOtrain / Signed in system

Trained with trainer

Go through procedures for release/return/reject products & destruction

QBIQ / ISOtrain / Signed in system

Corporate SOPs 015617 Repackaging of Marketed Novo Nordisk Products

E-Learnings N/A N/A N/A

Courses N/A N/A N/A

QBIQ / ISOtrain / Signed in system

Trained with trainer

QBIQ / ISOtrain / Signed in system

Corporate SOPs 184290 Change Control in Regions and Affiliates

66755 Change Control process

67393 Views, Advanced Search and Reports

E-Learnings 66756 System overview and navigation

39969 Change Control focusing on the QA role *)

83004 Linking to the Novo Nordisk processes

Courses 95845 Change Owner, QA and CR Expert Affiliates

Meet your buddy: __[initials]_