This presentation explores some proven, practical and effective Project Management concepts and solutions to enable organisations set their Project Managers up for success!

1. ISPE Australasian Conference 2009
MELBOURNE
Practical
SYDNEY
Project Management for
SINGAPORE
Life Sciences Projects
MALAYSIA
Presented by Kylie Brailsford,
Manager – Project Management
Office, Synertec
www.synertec.com.au
1
www.synertecasia.com © Synertec 2009

2. Purpose
Introduction
Life Science
Projects
This presentation explores some proven,
Where To
Start practical and effective Project
Project
Lifecycle Management concepts and solutions
The Project
Manager
Responsibility
to enable organisations set their
Support
Execution
Project Managers up for success
Suppliers
Project
Controls
Project
Phases
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

3. Agenda
Introduction
Life Science
Projects
• Introduction
Where To
Start • Where to Start
Project
Lifecycle
The Project
– Project Lifecycle
Manager
Responsibility
Support
• The Project Manager
Execution
Suppliers
• Execution
Project
Controls – Suppliers
Project
Phases
– Project Controls
Summary
– Project Phases
• Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

4. Standard Projects
Introduction
Life Science
Projects
All projects require management of:
Where To
Start • OH&S
Project
Lifecycle
The Project
Manager
• Cost
Responsibility
Support
• Schedule
Execution
Suppliers
• Technical Compliance
Project
Controls
Project
Phases
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

5. Life Sciences Projects
Introduction
Life Science
Projects
• Must provide Assurance &
Where To
Start Demonstration of Outcome
Project
Lifecycle
The Project
• Operating in a highly regulated
Manager
Responsibility environment for project planning,
Support
Execution
execution and management
Suppliers
Project
Controls
• Regulatory landscape applies across
Project
Phases
the whole organisation, top to bottom
Summary
• More “interested” parties, e.g. quality,
regulatory
Practical Project Management for Life Sciences Projects © Synertec 2009

6. How Life Sciences Project
are Achieved
Introduction
Life Science
Projects
• Validation
Where To
Start • Document Tracking / Collection
Project
Lifecycle
The Project
Manager
• Evidence Based Demonstration
Responsibility
Support
• Change Management
Execution
Suppliers
• Cleanliness during construction
Project
Controls
Project
Phases
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

7. Where to Start
Introduction
Life Science
Projects
• Think about Validation
Where To
Start • How to best manage projects that have
Project
Lifecycle
The Project
to be validated?
Manager
Responsibility • …Don’t make validation an add-on!
Support
Execution Integrate it into your standard project
Suppliers
Project
Controls
approach
Project
Phases
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

8. Validation Lifecycle
Introduction
Life Science
Projects
• Validation lifecycle (e.g. from GAMP 5 – can
Where To
Start
be applied to all types of projects, not just
Project
Lifecycle
automation):
The Project
Manager – Planning
Responsibility
Support – Specification
Execution
Suppliers – Build
Project
Controls
– Verification
Project
Phases
Summary
– Reporting and Release
– Operation & Maintenance
– Retirement
Practical Project Management for Life Sciences Projects © Synertec 2009

9. Validation-Project Lifecycle
Introduction
Planning Project, Validation & Quality
Life Science
Projects Planning (PVMP)
Where To
Start Specification Requirements Analysis
Project
Lifecycle Conceptual Design
The Project
Manager Detailed Design
Responsibility
Build Purchasing
Support
Execution
Build
Suppliers
Verification Factory Testing
Project
Controls
Installation (Construction)
Project
Phases Commissioning
Summary
Site Testing (Qualification)
Reporting & Release Reporting
Handover
Practical Project Management for Life Sciences Projects © Synertec 2009

10. Validation-Project lifecycle
Introduction
Life Science
Projects
Now we have:
Where To
Start • A standard approach to project
Project
Lifecycle
The Project
execution
Manager
Responsibility • That automatically complies with
Support
Execution validation requirements
Suppliers
Project
Controls
• And validation is not an “add-on” it is
Project
Phases integrated from project initiation
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

11. Take Advantage of
Defined Lifecycle
Introduction
Life Science
Projects
• Now that you have a defined lifecycle,
Where To
Start
what can you do with it?
Project
Lifecycle • Use it!...as much as possible to
The Project
Manager maintain consistency and efficiency
Responsibility
Support
within and across projects
Execution
Suppliers
– Delivery
Project
Controls
– Hard copy filing
Project
Phases – Electronic copy filing
Summary
– Cost estimate & control
– Schedule development & control
Practical Project Management for Life Sciences Projects © Synertec 2009

12. The Project Manager
Introduction
Life Science
Projects
• Now we have a structured lifecycle –
Where To
Start
who will manage it?
Project
Lifecycle • Allocate a specific Project Manager
The Project
Manager
Who
Responsibility
Support • Understands the requirements
Execution
Suppliers • Understands accountabilities for
Project
Controls
Project
delivery as separate to technical
Phases
Summary
compliance
• Can lead at multiple organisational
levels
Practical Project Management for Life Sciences Projects © Synertec 2009

13. PM Commitment
Introduction
Life Science
Projects
• PM doesn’t have to be a full-time role
Where To
Start on the project
Project
Lifecycle
The Project
• For smaller projects, PM can be a
Manager
Responsibility technical project resource, but:
Support
Execution
– needs to be a clear distinction between
Suppliers
PM tasks and technical tasks
Project
Controls
Project
Phases
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

14. Other Key Stakeholders
Introduction
Life Science
Projects
• To Support the PM, other roles should
Where To
Start be also defined
Project
Lifecycle
– Users
The Project
Manager
Responsibility
– System Owners
Support
Execution
– Quality Assurance
Suppliers
Project
– Quality Control
Controls
Project
Phases
– Project Sponsor
Summary
– Technical Experts
Practical Project Management for Life Sciences Projects © Synertec 2009

15. PM Responsibilities
Introduction
Life Science
Projects
• Clearly define the responsibilities:
Where To
Start
– Managing project team – “line
Project
Lifecycle
management” or just this project?
The Project
Manager – Technical accountability for outcome?
Responsibility
Support
– Client liaison?
Execution
– Conflict resolution?
Suppliers
Project
Controls
– Budget?
Project
Phases – Schedule?
Summary
– What authority do they have?
– Reporting requirements?
Practical Project Management for Life Sciences Projects © Synertec 2009

16. PM Accountabilities
Introduction
Life Science
Projects
Where To
Start
Project
Lifecycle
The Project
Manager
Responsibility
Support
Execution
Suppliers
Project
Controls
Project
Phases
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

17. PM Support
Introduction
Life Science
• Ensure that time and money is allocated for
Projects
PM activities
Where To
Start
Project
• Ensure that time and money is allocated for
Lifecycle life sciences “add ons”
The Project
Manager
• Allocate adequate project resources,
Responsibility
Support
including validation lead, technical writers,
Execution document controller
Suppliers
Project
• Provide tools and systems
Controls
Project
• Define management accountability
Phases
Summary
• Define management support and escalation
path for issues
• Define administration support available
Practical Project Management for Life Sciences Projects © Synertec 2009

18. QMS
Introduction
Life Science
Projects
• A number of the support systems
Where To
Start
required for projects already exist
Project
Lifecycle
within a Quality Management System:
The Project
Manager – Change Control
Responsibility
Support
– Document Control
Execution
Suppliers
– Non-Conformance Management
Project
Controls
– Communications
Project
Phases • May be beneficial to set up a QMS at
Summary
project initiation of it’s not already in
place
Practical Project Management for Life Sciences Projects © Synertec 2009

19. Project Requirements
Introduction
Life Science
Projects
• A Key Factor in setting up the PM is
Where To
Start clearly defining the project
Project
Lifecycle requirements
The Project
Manager
Responsibility • User Requirements Specification is an
Support
Execution
ideal forum – again utilising Life
Suppliers
Project
Science requirements to assist project
Controls
Project
Phases
management
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

20. Where To From Here
Introduction
Life Science
Projects
• Now we are set up for the projects,
Where To
Start what’s next?
Project
Lifecycle
The Project
• Managing Suppliers
Manager
Responsibility • Project Controls
Support
Execution
Suppliers
• Project Phase Issues
Project
Controls
Project
Phases
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

21. Supplier Engagement
Introduction
Life Science
• Consultants (e.g. Designers) /
Projects
Where To
Contractors / Vendors play a crucial
Start
Project
role, particularly in life science projects
Lifecycle
The Project
Manager
• Selection process is important, best to
Responsibility select organisations with industry
Support
Execution
experience / track record
Suppliers • Or develop processes to measure
Project
Controls those without industry experience
Project
Phases
Summary
• Give consideration to developing
partnerships / alliances with suppliers
Practical Project Management for Life Sciences Projects © Synertec 2009

22. Supplier Engagement
Introduction
Life Science
Projects
Where To
Start
Project
Lifecycle
The Project
Manager
Responsibility
Support
Execution
Suppliers
Project
Controls
Project
Phases
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

23. Supplier Management –
General Documentation
Introduction
Life Science
Projects
• Getting documentation (e.g. material
Where To
Start
certs, cal certs, design, manuals) from
Project
Lifecycle
suppliers can be difficult:
The Project
Manager – Time-wise AND
Responsibility
Support
– Quality-wise
Execution
Suppliers
• Clearly define expectations with
Project
Controls
supplier
Project
Phases • Money talks!
Summary
– Place specific commercial conditions
upon suppliers
Practical Project Management for Life Sciences Projects © Synertec 2009

24. Supplier Management –
Test Documentation
Introduction
Life Science
Projects
• Equipment vendors vary in ability to
Where To
Start produce compliant test documentation
Project
Lifecycle
The Project
• Need to assess each vendor – track
Manager
Responsibility record?
Support
Execution • Don’t necessarily dismiss vendors
Suppliers
Project
Controls
without the skills (they may have a
Project
Phases
great product!)
Summary
• Re-allocate part of their budget to a
third party to complete testing
Practical Project Management for Life Sciences Projects © Synertec 2009

25. Cost Management
Introduction
Life Science
Projects
• Allow for life science specific issues:
Where To
Start – Validation resources (people,
Project
Lifecycle documentation, test equipment etc.)
The Project
Manager
Responsibility
– Supplier supervision resources
Support (procurement checks, construction
Execution
Suppliers
supervision etc.)
Project
Controls – Estimate based on non-specialist
Project
Phases resources where appropriate
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

26. Schedule Management
Introduction
Life Science
Projects
• Allow for life science specific issues:
Where To
Start – Document review and approval (including
Project
Lifecycle post testing approval at each stage)
The Project
Manager
Responsibility
– Quality gates
Support
Execution
– Project audits – quality and technical
Suppliers – Formal testing after commissioning
Project
Controls
Project
– Time for adequate performance
Phases
Summary
monitoring
Practical Project Management for Life Sciences Projects © Synertec 2009

27. Document Control Space
Introduction
Life Science
Projects
Where To
Start
Project
Lifecycle
The Project
Manager
Responsibility
Support
Execution
Suppliers
Project
Controls
Project
Phases
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

28. Document Control
Resources
Introduction
Life Science
Projects
Where To
Start
Project
Lifecycle
The Project
Manager
Responsibility
Support
Execution
Suppliers
Project
Controls
Project
Phases
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

29. Document Control
Introduction
Life Science
Projects
• Consider storage allocation
Where To
Start • For both hard copies and electronic:
Project
Lifecycle – Use a filing system (not just a
The Project
Manager “warehouse”)
Responsibility
Support – Implement access control
Execution
Suppliers
– Restrict access further for approved doc.s
Project
Controls • Include control of informal
Project
Phases documentation & correspondence (e.g.
Summary
email)
Practical Project Management for Life Sciences Projects © Synertec 2009

30. Document Control
Interaction
Introduction
Life Science
Projects
• Ensure all parties have input to what
Where To
Start Doc Control will do for them during the
Project
Lifecycle project – different people have different
The Project
Manager
Responsibility
expectations
Support
Execution
• If Doc Control are required to check
Suppliers
Project
completeness of packages submitted,
Controls
Project
Phases
ensure they are given the lists to check
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

31. Document Map
S y s te m D o c u m e n t a t i o n R e l a ti o n s h i p F l o w c h a r t
Introduction H i s to r i c a l V e n d o r
0 1 . P ro p o s a l 0 2 . P la n n in g
0 3.
R e q u i r e m e n ts 0 4 . C o n c e p tu a l D e s i g n 0 5 . D e ta i le d D e s ig n 0 6 . P ro c u r e m e n t 0 7 . F a b r i c a ti o n 0 8 . T e s ti n g
Project Level Documents
D o c u m e n ts
A n aly s i s
SI A
F a c t o ry
Life Science PV Q P
C o d in g S t a n d a r d
Projects QA 1
Where To
Start
URS
Project
Lifecycle D o c u m e n t a ti o n
f ro m p a s t U p g ra d e
P r o je ct s
TR A
The Project FS
F-U
FA T
T-F
Manager
DR1 (S IT )
F DS
E x is tin g sy st e m VR A
code
Responsibility DR 2
SD S
D -F
S M IT
T -D
S MT
D DS
Support C o d e B u ild CR1
CR2
D -F
Execution HDS
DDS
Suppliers D r a w in g s
H ardw are
Project P r o c u r ed It e m s
V e r if ica t io n
Controls
D -F
E DS
Project DD S
Phases I /O L ist
D r a w in g s
E le c tr ic a l
Summary
System Level Documents
LE G EN D R e q u ir e m e n t s D e f i n i t i o n A c t i v i t ie s V e r i f ic a t i o n A c t iv i t i e s R e v ie w M e e t in g s a n d A s s e s s m e n t s
S M IT S o ft w a r e M o d u le a n d In t e g r a t io n T e s t M S W ord
U RS U se r R e q u ir e m e n ts S p e c ific a t io n SI A S y s te m I m p a ct A ss e s sm e n t D oc um ent F a b r ic a t io n o r S y st e m D a t a o r R e vie w A c tiv it y
S M T S o ft w a r e M o d u le T e st D a t a S h e e t TR A T e c h n ic a l R i sk A ss e ss m e n t In st a lla tio n A ct ivit y C ode
F S F u n c tio n a l S p e cif ica tio n F A T F a ct o r y A cc e p ta n c e T e s t VR A V a l id a tio n R is k A s se s s m e n t
F DS C o m p o n e n t F u n c tio n a l D a t a S h e e t S IT S o ft w a r e In t e g r a tio n T e st
H IT H a r d w a r e I n st a lla t io n T e st C R1 C o n t r o l C o d e R e v ie w
S DS S o f tw a r e D e s ig n S p e c ific a tio n E IT E le ct r ica l I n st a lla tio n T e st C R2 U se r I n te r f a c e C o d e R e v ie w
H DS H a r d w a r e D e sig n S p e cif ica t io n
E DS E le c tr ic a l D e sig n S p e cif ica t io n IC C o m p o n e n t I n st a lla t io n C h e ck VR 1 D Q V a lid a t io n R e vie w a n d A p p r o va l C om pon ent C om ponent
C AD
D DS C o m p o n e n t D e sig n D a t a S h e e t OC C o m p o n e n t O p e r a tio n C h e c k VR 2 IQ V a lid a tio n R e v ie w a n d A p p r o v a l S p e cif ica tio n C hec k D ata D r a w in g s R TM or TT M
CIC C o m p o n e n t C la s s I n st a lla tio n C h e c k VR 3 O Q V a lid a t io n R e vie w a n d A p p r o va l D ata S heet S heet
CO C C o m p o n e n t C la s s O p e r a t io n C h e ck VR 4 P Q V a lid a tio n R e v ie w a n d A p p r o v a l
DQ D e s ig n Q u a lific a tio n QA 1 P r o je ct A u d it o n D e sig n C o m p le t io n
IQ I n st a lla tio n Q u a lif ic a tio n QA 2 P r o je ct A u d it o n C o m p le tio n
OQ O p e r a t io n Q u a lific a t io n
P Q P e r fo r m a n c e Q u a l ific a tio n
Practical Project Management for Life Sciences Projects © Synertec 2009

32. Change Management
Introduction
Life Science
Projects
• Consider what Change Management
Where To
Start System (CMS) is used and when
Project
Lifecycle
The Project
• Define when to move from Project
Manager
Responsibility CMS to Organisational CMS, e.g.
Support
Execution
before qualification
Suppliers
Project
Controls
Project
Phases
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

33. Communications
Control
Introduction
Life Science
Projects
• Important to co-ordinate
Where To
Start communication between all parties –
Project
Lifecycle more significant in life sciences project
The Project
Manager
Responsibility
as there are generally more parties
Support
Execution
involved:
Suppliers – Engineers
Project
Controls
Project
– Suppliers
Phases
Summary – Validation
– Quality
– Users etc
Practical Project Management for Life Sciences Projects © Synertec 2009

34. Project Phases -
Project Planning
Introduction
Life Science
Projects
• Plan for the appropriate regulations for
Where To
Start the life of the system:
Project
Lifecycle
– Know your regulators and their
The Project
Manager
Responsibility
requirements now and going forward
Support
Execution
Suppliers
Project
Controls
Project
Phases
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

35. Requirements Analysis
Introduction
Life Science
Projects
• Include ALL interested parties in
Where To
Start
requirements analysis and design
Project
Lifecycle – End users / production
The Project
Manager – System owners
Responsibility
Support – Quality representatives
Execution
Suppliers
– Maintenance
Project
Controls
– Technical experts
Project
Phases • These people will understand life
Summary
science issues specific to their plant
better than project staff
Practical Project Management for Life Sciences Projects © Synertec 2009

36. Design
Introduction
Life Science
• Design is crucial!
Projects
Where To
Start
• Select a good designer that understands the
Project
Lifecycle
requirements Ensure client involvement in
The Project
Manager
design to avoid changes later
Responsibility • Establish the appropriate “order of design”
Support
Execution
for life science projects, e.g. GMP services
Suppliers after layout
Project
Controls • Ensure IFC documentation is rigorous &
Project
Phases complete to allow contractors to do their jobs
Summary
properly
Practical Project Management for Life Sciences Projects © Synertec 2009

37. Purchasing
Introduction
Life Science
Projects
• Purchasing procedures can be utilised
Where To
Start to decrease formal testing required
Project
Lifecycle later in the process
The Project
Manager
Responsibility • For e.g. receipt verification can actually
Support
Execution
cover much of the IQ testing
Suppliers
Project
requirements
Controls
Project
Phases
• So need to ensure that appropriate
Summary
purchasing procedures are
documented and traceable
Practical Project Management for Life Sciences Projects © Synertec 2009

38. Factory Testing
Introduction
Life Science
Projects
• Factory Testing can be utilised to
Where To
Start minimise formal site testing, so it is
Project
Lifecycle important to life science projects
The Project
Manager
Responsibility • Need to ensure the appropriate people
Support
Execution
are involved
Suppliers
Project
Controls
• Need to ensure it is appropriately
Project
Phases
documented and traceable to design
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

39. Installation
(Construction)
Introduction
Life Science
Projects
• Need to minimise risk during
Where To
Start construction phase that could delay
Project
Lifecycle formal testing later
The Project
Manager
Responsibility
– Cleanliness (maintaining clean work area
Support and protecting finishes)
Execution
Suppliers – Clarify scheduling requirements &
Project
Controls priorities
Project
Phases
Summary
– Allow adequate and regular supervision
Practical Project Management for Life Sciences Projects © Synertec 2009

40. Commissioning
Introduction
Life Science
Projects
• Commissioning must be done right to
Where To
Start minimise risk to formal testing
Project
Lifecycle
The Project
• Also, as per recent industry trends,
Manager
Responsibility commissioning can supplement formal
Support
Execution
testing, so it should be done right first
Suppliers
Project
time
Controls
Project
Phases
• E.g.:
Summary
– formalise P&ID walk-downs
– complete in situ instrument calibrations
Practical Project Management for Life Sciences Projects © Synertec 2009

41. Formal Testing -
Preparation
Introduction
Life Science
Projects
• Balance between:
Where To
Start – Getting protocols ready early
Project
Lifecycle
The Project
– Design changes impacting completed
Manager
Responsibility
protocols
Support
Execution
Suppliers
Project
Controls
Project
Phases
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

42. Formal Testing -
Execution
Introduction
Life Science
Projects
• Often the project is under time
Where To
Start pressure by this phase
Project
Lifecycle
The Project
• Don’t be pressured to test too early!
Manager
Responsibility
Support
Execution
Suppliers
Project
Controls
Project
Phases
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

43. Reporting
Introduction
Life Science
Projects
Where To
Start
Project
Lifecycle
The Project
Manager
Responsibility
Support
Execution
Suppliers
Project
Controls
Project
Phases
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

44. Handover
Introduction
Life Science
Projects
• Allow for adequate training and SOPs
Where To
Start so that end users understand the
Project
Lifecycle regulatory impact of the end product
The Project
Manager
Responsibility
Support
Execution
Suppliers
Project
Controls
Project
Phases
Summary
Practical Project Management for Life Sciences Projects © Synertec 2009

45. Summary
Introduction
Life Science
Projects
• Set up a standard methodology that
Where To
Start incorporates Life Sciences
Project
Lifecycle requirements
The Project
Manager
Responsibility • Select an appropriate Project Manager
Support
Execution • Support the PM with resources, tools
Suppliers
Project
Controls
and systems
Project
Phases • Select appropriate Suppliers
Summary
• Set up appropriate controls
Practical Project Management for Life Sciences Projects © Synertec 2009

46. Melbourne Head Office - Synertec Pty Ltd, Level 1, 57 Stewart St, Richmond VIC 3121, Australia Tel: + 61 3 9274 3000 Fax: + 61 3 9274 3099
Sydney Synertec Pty Ltd, Suite 208, 25 Berry St, North Sydney NSW 2060, Australia Tel: + 61 2 9922 3233 Fax: + 61 2 9922 6255
-
Singapore Synertec Asia Pte Ltd, Spring Singapore Building, 2 Bukit Merah Central, #14-04, Singapore 159835 Tel: + 65 6377 0865 Fax: + 65 6377 0870
-
Malaysia Synertec Asia (M) Sdn Bhd, Level 28 Central Plaza, 34 Jalan Sultan Ismail, 50250 Kuala Lumpur, Malaysia Tel: +603 2147 4535 Fax: +603 2147 4666
–
www.synertec.com.au
© Synertec 2009