Prima 10 wolf-6-17

building bridges
between people with the information
and the people who need it

AAggeennddaa
1. Service overview / Client results
May not be aware of all we can offer
Seasoned, proven offerings that help
clients save $
1. Corporate culture / Client results
2. Summary: How we can help Pfizer
save $
3. QA

SSeerrvviiccee oovveerrvviieeww // CClliieenntt rreessuullttss
Services that help clients
Procedures / Operational documentation
Engineering documentation
Process analysis
Training
Project support
Ghost communications

Experience: entire life cycle (Classification
schemes – Develop – Maintain – Training)
Well qualified
Cornerstone since 1991
Partnered with four pharmas to integrate “lean”
Understand requirements for a cGMP
environment (change control, “aseptic technique”,
etc.)
Clients in FDA-regulated industries,
manufacturing, banking, engineering

Results:
Compliance
Quality – passionate about effective
communication
Allows technical personnel to:
Do what they do best
Be used more cost-effectively
Do the next great thing while we document,
train, handle revisions, etc.

Reqs, specs, meeting minutes, CQ, validation documents,
project notebooks
Entire life cycle (project conception through
completion)
Well qualified
Tools methods
Technical backgrounds
Since 1991
Clients in pharma, manufacturing, food
beverage, engineering

Results:
Compliance
Quality: highly detailed, organization-critical
work performed by people who are passionate
about it

CQ / Validation
Experience with:
Documentation from User Requirements through
Validation Reports
Packaging
Computer
Process
Product
Cleaning
Facility / Utility
Execution

CQ / Validation Execution
Generally more cost-effective than
engineering / validation companies
Very familiar with change control process,
and ensuring documents are compliant
Our goal: consistently produce approvable,
defendable documentation
Utilizing Prima can gain savings

Process analysis
Facilitation, mapping, analysis (gaps, Best
Practice, differing requirements, etc.)
Experienced well qualified:
PGRD’s GO IT project (facilitation, map
development, gap analysis … La Jolla, St. Louis,
Manhattan, Ann Arbor, Groton, Sandwich)
PGM MBR (Modular Batch Records)
MAPS
LIMS

Process analysis
Uniquely positioned:
Experience across the enterprise (IT, RD,
manufacturing, project engineering, corporate-level
entities)
Experience with other pharma

Process analysis
Results:
Compliance, quality
Effective
Neutral “third party”
Sensitive to each area’s needs
Identify and handle issues early

Process analysis typical project
Provide a bridge between the Business
Areas and the Developers when a new
system or application is being developed

Process analysis typical project – cont’d
Work with the Business areas to
identify:
Processes impacted by the new application
Current work flow
Requirements of the new system/application
Then, work with all parties to:
Reengineer the existing manual processes to
fit with the new system/application

Process analysis typical project – cont’d
Communication facilitation
Communicate requirements to developers
Test the applications as developed to ensure
the Business requirements were met
Facilitate Conference Room Pilots to ensure
system/application is accepted by end users
Develop execute training plan
Execute Unit Testing for validation
Execute IQ PQs
Facilitate issue resolution through pilot roll-out

Training
Entire life cycle (Needs analysis  content 
delivery  assessment)
All formats
CBTs
Instructor-led
Well qualified: 100s of courses for
manufacturing, telecommunications,
maintenance, pharma clients

Training
Results:
Compliance, quality
Effectiveness (bridging SMEs and users)
Best Practice content
Do the next great thing

Project support
Assist in all phases of project management;
emphasis on project communications and
controls
Project Support Service provider --
infrastructure in place to train, support these
services
Well qualified:
Tools methods
Experience

Project support
Results:
Compliance, quality
Effectiveness
Do the next great thing

Examples:
Newsletters
Speeches
Presentations (PPT to video)
White papers
Technical journal articles
Project launch “buzz”
Well qualified: 100s of publications and
programs for many industries

Define deploy Best Practices
Enhanced organizational communications
Industry peer recognition
Results:

AAggeennddaa
1. Service overview / Client results
2. Corporate culture / Client
results
3. Summary: How we can help
Pfizer save $
4. QA

80+ employees
Brightest (5 years in a row)
One of West Michigan’s 101 Best
Certified woman-owned business
Michigan corporation: 1991
Technical communications company
CCoorrppoorraattee ccuullttuurree // CClliieenntt rreessuullttss
First, a bit about Prima …

Motto: Whatever It Takes
Three locations:
Schoolcraft
Portage
Indianapolis

Partial list of other clients
Coca-Cola of North America
Daimler-Chrysler
Dow Chemical
Emergent Biosolutions
Eli Lilly
HardTek Auditing Solutions
Hammond Roto-Finish
Hospira
Inter-Source Recovery Systems, Inc.
Kalamazoo Department of Public Works
Perrigo
Vaupell

1. Team-based
Substantial body of knowledge readily
available to all
Expertise at the ready
Strong internal communications focus
 Efficiently serve our clients

2. Project-based
Infrastructure to support onsite or offsite
 Flexibility
 Ability to quickly react

3. Service provider, not a placement
agency
Robust benefits to attract retain talent
BDT infrastructure
 Training opportunities to keep personnel
challenged, engaged becoming more
valuable: retention

3. Service provider, not a placement
agency (cont’d) -- training
Last year: 62 different Primas attend
4,640 hours of training
YTD: 48 different employees attend 1,556
hours of training
Prima-paid training demonstrates our
commitment to employee development
 Increased skill sets and effectiveness

AAggeennddaa
1. Service overview / Client
results
2. Corporate culture / Client
results
3. Summary: How we can help
Pfizer save $
4. QA

HHooww wwee ccaann hheellpp PPffiizzeerr ssaavvee $$
1. Best use technical personnel
(Engineers doing engineering,
accountants costing items, writers
writing)
1. More attractive rates than AE,
validation, CM organizations
2. Focus and enthusiasm on
communications
3. In-house expertise

HHooww wwee ccaann hheellpp PPffiizzeerr ssaavvee $$
5. Efficiencies from enterprise-wide
experience sensitivities
Working upper-level management
Identify develop initiatives
5. Highly effective
Experience
Skill set
Technical backgrounds
ASQ: CQA, CQE
Quality Auditors for QS9000, ISO 900X, TS16949 etc.
Attitude

Prima 10 wolf-6-17

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