This document provides an overview of project management in a biopharmaceutical manufacturing environment. It discusses the key drivers in this environment beyond typical cost, schedule, and resource constraints, including supplying product to patients and compliance with regulations. The presentation focuses on an overview of a project to support manufacturing, differing aspects of quality between PMBOK and cGMP standards, and skills for project managers to thrive in a cGMP environment.

1. ITIT--focused Project Managementfocused Project Managementj gj g
in a Biopharmaceuticalin a Biopharmaceutical
Manufacturing EnvironmentManufacturing Environment
Bruce Kozuma, PMP
Manufacturing EnvironmentManufacturing Environment
Manager, Project Management, Applications
Biotech Information Services
2007/06/122007/06/12

2. Synopsis
n There are drivers of Project Management in a
biopharmaceutical manufacturing environment in addition to
h l h d l d i hi fl hthe usual cost, schedule, and resources constraints, chiefly the
following:
Supply of product to patients
Compliance with regulations/standards (e.g., cGMP, CFR 21 Part 11, SOX)
n The presentation will focus on the following topics of
particular interest to Project Management Institute (PMI)
members:
Overview of the project to support a biopharmaceutical manufacturing environment
Differing aspects of Quality stressed between a straight Project Management Book
Of Knowledge (PMBOK) and a typical current Good Manufacturing Practice (cGMP)
environment
2006/12/062
Skills for Project Managers to thrive in such a cGMP environment

3. Topics
n Wyeth Corporate Overview
/ On Andover/Wilmington Overview
n SAP MRP Project Overview
P j t M t i Bi t hn Project Management in Biotech
n Questions
2006/12/063

4. Wyeth Corporate Overview
Wyeth Corporate OverviewWyeth Corporate Overview
Last Updated: June 21 2006Last Updated: June 21, 2006
For questions or comments, contact:
Diana Blankman
Corporate Public Affairs
Blankmd@wyeth.com
973-660-6081
2006/12/064

5. Andover/Wilmington Overview
A d Sit O iA d Sit O iAndover Site OverviewAndover Site Overview
Welcome to Andover
22Nov06
2006/11/02 22 43
Biotech2006/11/02 22:43
Biotech
2006/12/065

6. ocess:
siness
ystems
SAP MRP Project Overview
1 of 3 SAP Implementation
Pro
Bus
Sy 1 of 3 SAP Implementation
n SAP MRP: LIVE August 1, 2006!
S d d b i d
n Some firsts for Wyeth:
Fi t d l t f SAPn Standard business processes and
tools for:
Inventory management
Warehouse management
First deployment of SAP
Manufacturing/Warehousing/Costing
functionality at a Wyeth Clinical
Manufacturing site
First to implement global planning from
Affili t d d th h b lk d
Production data management
Genealogy
Product usage decision
Affiliate demand through bulk drug
substance
Final US site to implement SAP MRP,
providing Wyeth with full visibility across
all US plants
n Success Factors:
Subject matter expertise – the team
really knows their stuff!Andover
Development
Supply
Partnership Site
Leadership at all levels
Leveraging Grange Castle model
Collaboration, collaboration,
collaboration!
Development
Great Valley
SAP Team
Biotech
Technology &
Engineering
Partnership Site
2006/12/066
Biotech
Supply Network
Planning
Andover
Commercial
g g

7. SAP MRP Project Overview
2 of 3
n Schedule (two year project)
I iti ti 2004/10Initiation: 2004/10
- Kick Off: 2005/02
Design: 2005/02 – 08
Implementation: 2005/08 – 2006/02
Go Live Prep: 2006/02 – 08
- Go Live: 2006/08
Cutover: 2006/08 – 10
- Ongoing operations: 2006/10
2006/12/067

8. SAP MRP Project Overview
3 of 3
n Resources
Resources were employees (> 80) and contractors (~20)Resources were employees (> 80) and contractors (~20)
450+ end users
Governancen Governance
Corporate
- Information Systems/Business Process Management group
SAP ifi t- SAP-specific management
- Topic-specific tasks forces (e.g., Master Data coordination)
Site
- Coordinated program to implement Enterprise Resource Planning (ERP)- Coordinated program to implement Enterprise Resource Planning (ERP),
Manufacturing Execution System (MES), Laboratory Information Management
System (LIMS), and Integration
- Business-owners: manufacturing, quality, supply chain
2006/12/068

9. Project Management In Biotech
n Drivers in Biotech Environment
f Cn Basic Notions of Compliance and Validation
n Different Aspects of Quality
Th i i P j t M i Bi t hn Thriving as a Project Manager in Biotech
2006/12/069

10. Basic Notions of Compliance and
ValidationValidation
n Validation
Establishing documented evidence which provides a high degree of assurance that ag p g g
specific process will consistently produce a product meeting its predetermined
specifications and quality attributes
- http://www.fda.gov/ora/inspect_ref/igs/gloss.html
Validation coverage should be based on the software’s complexity and safety risk – notg p y y
on firm size or resource constraints.
- http://www.fda.gov/cdrh/comp/guidance/938.html#_Toc517237933 (section 4.8)
n What is [21 CFR] Part 11?n What is [21 CFR] Part 11?
Regulation allowing FDA to accept electronic records and signatures in place of paper
records and handwritten signatures.
Describes controls to ensure that electronic records and signatures are
- Trustworthy
- Reliable
- Compatible with FDA work
http://www.fda.gov/cder/regulatory/ersr/2002 11 05 standards1/sld003.htm
2006/12/0610
p // da go /cde / egu a o y/e s / 00 _ _05_s a da ds /s d003

11. Drivers In a Biotech
n Not just Scope, Schedule, Cost
n Supply of Product
Supply of products in a compliant manner to patients cannot be disrupted
n Compliance
Adherence with all applicable US Federal regulations, chiefly cGMP, 21 Code of
Federal Regulations (CFR) Part 11, SOX (Sarbanes-Oxley)
Oversight by regulatory bodies in all markets where products produced or managed byOversight by regulatory bodies in all markets where products produced or managed by
company
Consequences of being out of compliance can be life threatening to patients and highly
detrimental to company
http://www fda gov/foi/warning htm- http://www.fda.gov/foi/warning.htm
n Affects project management by making primary focus on ongoing
operations first, projects second
2006/12/0611

12. Different Aspects of Quality
1 of 4
n Purpose of Compliance is to lead to higher quality pharmaceutical
products
n PMI defines quality as follows:
Quality is “the degree to which a set of inherent characteristics fulfilly g
requirements”.
Stated and implied needs are the inputs to developing project
requirements.
A critical element of quality management in the project context is to
k h ld d d i i iturn stakeholder needs, wants, and expectations into requirements
through Stakeholder Analysis (Section 5.2.2.4), performed during
Project Scope Management.
2006/12/0612

13. Different Aspects of Quality
2 of 4
n APICS (The Association for Operations Management) defines quality
as follows:
Quality: Conformance to requirements or fitness for use. Quality can be
defined through five principal approaches:
(1) Transcendent quality is an ideal, a condition of excellence.
(2) Product-based quality is based on a product attribute.
(3) User-based quality is fitness for use.
(4) Manufacturing-based quality is conformance to requirements.
(5) Value-based quality is the degree of excellence at an acceptable price.
Also, quality has two major components:
(1) quality of conformance—quality is defined by the absence of
defects anddefects, and
(2) quality of design—quality is measured by the degree of customer
satisfaction with a product’s characteristics and features.
2006/12/0613

14. Different Aspects of Quality
3 of 4
n Quality of design: Handled by drug development process
Pre-clinical research (synthesis and purification, animal testing, Institutional Review Boards)
Clinical Studies (Phase 1, 2, 3)
New Drug Application (NDA) submission and review
http://www.fda.gov/cder/handbook/develop.htm
n Quality of conformance: handled by compliance to regulations
Purpose is to ensure Safety, Identify, Strength, Purity Quality of pharmaceutical products
f C fTitle 21 of the Code of Federal Regulations, Food and Drug Administration, Department
of Health and Human Services
- http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm
Current Good Manufacturing Practice
- http://www.ispe.org/page.ww?section=GMP&name=What+Is+GMP%3F
- http://www.fda.gov/cder/dmpq/cgmpregs.htm
- http://www.fda.gov/bbs/topics/NEWS/2002/NEW00829.html
2006/12/0614
p g p

15. Different Aspects of Quality
4 of 4
n My take on PMBOK Quality and cGMP Compliance
Q lit f PMBOK ti f i t fQuality from a PMBOK perspective focuses on ensuring outcome of
projects meet customer needs (broadly defined)
Q alit f om a cGMP pe specti e foc ses p edominantl on ens ingQuality from a cGMP perspective focuses predominantly on ensuring
ongoing operations and the outcome of projects are compliant with FDA
regulations and industry standards (particularly cGMP, CFR 21 Part 11, Good
Automated Manufacturing Practices (GAMP), SOX)
2006/12/0615

16. Consequences Different Aspects of Quality
1 of 2
n Quality Management Tools sound similar, but cGMP has force of
Law
Cost of Poor Quality (PMBOK): poorly executed project, customer expectations not met, unhappy
customers, loss of competitive market position, loss of shareholder value, legal action
Cost of Poor Quality (cGMP): All of the above plus license revocation, licenses suspension,y ( ) p , p ,
injunction, seizures, warning letters, fiscal penalties
n Will apply both Project Quality Project management and Compliance
to cGMP projects but Compliance has primacyto cGMP projects, but Compliance has primacy
n Role of Quality Manager on cGMP projects is entirely different than
on non cGMP project Quality Manager on cGMP projects:on non-cGMP project, Quality Manager on cGMP projects:
The key approver on compliance documents
The lead person to answers auditors
2006/12/0616

17. Consequences Different Aspects of Quality
2 of 2
n I haven’t figured out how to make Earned Value Management useful
in cGMP environment
Until Quality Manager signature obtained, Earned Value (EV) of project deliverables is
zero, despite Actual Cost (AC) incurred
High negative Cost Variance (CV) is common (CV = EV – AC, with EV = 0)High negative Cost Variance (CV) is common (CV EV AC, with EV 0)
Zero Cost Performance Index (CPI) is common (CPI = EV/AC, with EV = 0)
E if Pl d V l (PV) k S h d l V i (SV EV PV) d S h d lEven if Planned Value (PV) known, Schedule Variance (SV = EV – PV) and Schedule
Performance Index (SPI = EV/PV) hard to calculate except at milestones
2006/12/0617

18. Thriving as a Project Manager in Biotech
n Know your target: IT or general Pharmaceutical Project Management
Fewer IT PM jobs, but lower requirements, e.g., experience in any regulated market such as
fi ISO DOD ffifinance, ISO, DOD can suffice
Lots of Pharmaceutical PM jobs, but requires domain knowledge and high qualifications, e.g.,
- Ph.D in Biology, Biochemistry, Microbiology, Bioinformatics and 1-2 years experience
- MBA + 5 years experience
- B S and 10+ years experience- B.S. and 10+ years experience
n Understand difference between PMBOK Quality and cGXP Compliance
Validation, Compliance, Quality
GXP ( t G d Cli i l P ti ( GCP) t G d L b t P ti ( GLP) GMP)cGXP (current Good Clinical Practice (cGCP), current Good Laboratory Practice (cGLP), cGMP)
n Soft skills
Flexibility
Wide view so can gauge degree of affect events on projects
Strong focus on customer internal and external
Strong negotiation skills
Insist on proper project governance
2006/12/0618
p p p j g
Clearly define roles/responsibilities/expectations

19. Questions/Comments
n You MUST have a few
2006/12/0619