Protocol Link, Inc.
HQ: Vernon Hills, Illinois, USA
Offices: East Coast, Midwest, West Coast, India
Inception: 1996
Projects: 783
Staff: 50
Company Profile
“Protocol Link’s mission is to provide customer-focused
consulting services with ethical conduct, mutual trust,
and personnel empowerment.”
Introduction and Profile
HQ in Vernon Hills, IL
Staff: 50Projects Completed: 761
Fortune 50 Companies:
14 Accounts
Inception: 1996
Regional
Offices:
California
Wisconsin
India

Protocol Link, Inc.
Our Clients
TTI, Japan
Our 3rd Party Sites
KP Pharmaceuticals

Protocol Link, Inc.
= Protocol Link Offices
San Jose
Las Vegas
Vernon Hills
Puerto Rico
Company Profile
Projects Worldwide
Company Profile
= Protocol Link Offices
Projects Worldwide

Protocol Link, Inc.
Company Profile
Projects Worldwide
Regulatory
Affairs
Quality
Systems
Validation
Compliance
Management
cGMP / QA
Documentation
Technical
Services
Training
Programs
Business
Solutions
Company Profile

Protocol Link, Inc.
Company Profile
“The management of the many projects that Protocol Link
has delivered has been very professional, organized and
systematic.”
“….there is something in Protocol Link’s documents that
distinguishes and sets them apart from other contractors
who perform similar works. The grasp for details are always
maintained throughout.”
“….this becomes a standard against which other contractors
are judged and measured.”
“….showed excellent capabilities in managing this very
complex project in the sterile manufacturing area.”
“….expertise and support was instrumental in the progress of
that project.”
“….one of the best validation companies I have worked with.”
“.…consistently demonstrated a high level of expertise and
professionalism in both the project management and
technical activities….”
“….high quality and thoroughness of your work.”
“….could always be counted upon to ‘get the job done’
according to plan.”
“….very professional and knowledgeable in your fields. We
could not have done .… in a timely fashion without your
help.”
“.…repeatedly benefited from your team’s wealth of
knowledge regarding FDAregulations and requirements.
Your assistance in Pharmpak’s cleaning, equipment and
software validation programs has been integral to the
success of our compliance program.”
“With each and every project, I have been
impressed with Protocol Link’s dedication
and commitment to excellence.”
Company Profile
“Protocol Link has always conducted business efficiently and
has always been looked upon as a very professional and
courteous group of people. Efficiency accompanied by
courtesy is a rare combination in today’s working world. The
courtesy extended by your team has been appreciated ....”
“….was knowledgeable, professional and a delight to interact
with.”
“Your organization has always provided excellent service. The
input of your team has been valuable….”
“….both from a professional and a personal level, the
thoroughness, accuracy, of your work along with experience
and ideas that you bring….”
“Our QA has been very happy with you….”
“As always, Protocol Link is my first choice.…”
“I have personally been very impressed by....engagement,
leadership and knowledge base during the process. I would
also like to thank you for your personal involvement and for
the responsiveness of your organization. This is a clearly
very positive start to our working relationship and I would
hope and like to see us working together on many more
projects in the future…. ”
“If you are looking for some help with validation work, I
would recommend talking to Protocol Link. We were very
pleased with the quality and quantity of the work provided,
and we found our on-site consultant to be practical and easy
to work with.”
“You’ve been a great support….I’m sure this is probably
common practice for you, but we just wanted to extend our
gratitude.”

Protocol Link, Inc.
Company Profile
Company Profile

Protocol Link, Inc.
Personnel Qualifications
2005 PDA Annual Meeting & Conference
April 4-6, 2005
Chicago, Illinois
Event Sponsor (Dipak Doshi)
Exhibitor
2005 India ISPE/FDA PAT Forum
February 25, 2005
Mumbai, India
Event Sponsor (Ginni Doshi)
Meeting Host (Steve Weltler)
2004 American Society for Quality
Software, Div. Region 12 Meeting
September 13, 2004
Skokie, Illinois
Workshop Facilitator (Tom McGrady)
Leveraging Software Quality Audits
2005 University of Tennessee Course
October 17-18, 2005
Memphis, Tennessee
Adjunct Professor (Dr. Lisa McChesney-Harris)
Strategies for Performing Scale Up and
Validation
2004 University of Tennessee Course
June 18, 2004
Memphis, Tennessee
Adjunct Professor (Tom McGrady)
Strategies for Performing Scale Up and
Validation
2003 Wisconsin Life Science & Venue Con
November 3-5, 2003
Madison, Wisconsin
Gold Sponsor (Neelone Cestkowski)
Exhibit
2004 PDA Midwest Chapter Mtg. & Exhibit
March 25, 2004
Northbrook, Illinois
Guest Presenter (Dr. Dan Hoch)
Laboratory Quality Priorities
Exhibitor
2002 Tech. Information Inst. Workshop
April 20-24, 2002
Tokyo, Japan
Workshop Presenters
(Steve Weltler & Mita Shah)
FDA Compliance Lessons
2000 PDA Spring Meeting & Conference
March 6-8, 2000
Chicago, Illinois
Exhibitor (Dipak Doshi)
2001 Process Validation Conference
November 5-7, 2001
Philadelphia, Pennsylvania
Course Instructor (Dr. Dan Hoch)
Cleaning Validation
2003 Abbott Global Extraneous Matter
Summit Meeting
May 2-3, 2003
Skokie, Illinois
Featured Speaker (Steven Weltler)
Extraneous Matter: Overview of the Total
Quality Systems Approach
TTI, Japan
Personnel Qualifications
2010 PDA Midwest Chapter Mtg.
November, 2010
Featured Presenter (Dr. Dan Hoch)
Technology Hurdles Associated with the eCTD
Submission
2009 BioForward Madison Breakfast
Meeting
June 10, 2009
Madison, Wisconsin
Host and Speaker (Neelone Cestkowski)
Process Done Right
2010 PDA/FDA Joint Regulatory
Conference
September 2010
Washington, DC
Recalls 101 – an Industry Perspective
2007 BioForward Madison Breakfast
Meeting
August 8, 2007
Madison, Wisconsin
Host and Speaker (Steven Weltler)
Managing the FDA Relationship from
Development to Commercialization
April, 2007
Las Vegas, Nevada
Platinum Event Sponsor (Dipak Doshi)
April 24-26, 2006
Anaheim, California
Platinum Event Sponsor (Dipak Doshi)
OOS Case Study (Dr. Lisa McChesney-Harris)
Exhibitor
2012 PDA Midwest Chapter Mtg.
February 28, 2012
Regulatory and Quality Inspection Trends
2006 BioForward Breakfast Meeting
May 10, 2006
Madison, Wisconsin
Host and Speaker (Dr. Dan Hoch)
Application of the cGMPs from Development to
Commercialization
TTI, Japan

Protocol Link, Inc.
Services Provided
ComplianceMgt. Gap Analyses
Compliance Assessments
Quality SystemAction
Plans
21 CFR Part 11 Compliance
Mock FDA Inspections
PAI Readiness Reviews
FDA 483 / Warning Letter /
Consent Decree
Management
Data Integrity Reviews
Product Corrective Actions
QualitySystems
Quality Master Plans
Quality Systems
QA / Vendor Audits
CAPA Systems
OOS Compliance
Stability Programs
Product Complaints
Handling
Annual Product Reviews
cGMP Design Reviews
Investigation Management
Validation
Validation Master Plans
Validation Protocols/
Reports
Validation Field Execution
Equipment Qualification
Utility SystemValidation
Facility Qualification
Computer System
Validation
Test Method Validation
Cleaning Validation
Process Validation
BusinessSolutions
Business Strategies
Management Consulting
Project Management
Risk-Based Approach
Merger / Acquisition
Assessments
Operations Management
QA / QC Management
Laboratory Management
Validation Management
Facility Shutdown
Management
cGMPDocumentation
Manufacturing Instructions
Master Batch Records
Manufacturing Batch
Records
Packaging Batch Records
Corporate Policies
Site Procedures (SOPs)
Specifications
Engineering Drawings
Product Corrective Actions
RegulatoryAffairs
Regulatory Affairs
Management
CDER / CBER / District
Liaison
Drug Master Files (DMFs)
eCTD Processing
Submission Preparation
BLA Submissions
Annual Reports
Product Recall
Management
Drug Registration and
Listing
Registered Agent with US
FDA
TechnicalServices
Technology / Method
Transfer
Contract Manufacturing
Setup
Calibration / PM Programs
Design of Experiments
Statistical Analysis
Database Design /
Development
Data Tracking & Trending
BMS, LIMS, ERP Systems
TrainingPrograms
Basic cGMP Requirements
cGMPs for the 21st Century
Good Documentation
Practices
Validation and Change
Control
Quality System Inspection
Technique (QSIT)
Current FDA Enforcement
Trends
Out of Specifications (OOS)
Correctiveand Preventive
Actions (CAPA)
Process Analytical
Technology
FDA Inspection Readiness
Experience and Capabilities
CriticalSystems&
Facilities
WFI and Purified Water
Systems
HVAC System
Clean Steam System
Nitrogen System
Compressed Air System
Clean Rooms
Vacuum Systems
Pilot Plant
Clinical Scale
Commercial Manufacturing
Packaging and Labeling
Repackaging
Warehousing and
Distribution
Pharmaceutical
Equipment
FormulationTanks
Mixers, Grinders, &
Blenders
Compression Machines
Film / Spray Coaters and
Dryers
Sterilizing Filters &
Sterilizers
Vial & Stopper Washers
Depyrogenation Ovens /
Tunnels
Filling / Crimping / Sealing /
Capping Machines
Lyophilizers
Refrigerators / Freezers /
Incubators
Packing/Label
Equipment
Inspection Machines
Roll Label Counters
Label Machine
Vision Systems
Coders
Blister Packaging
Bar Code Readers
RFID Scanners
Processes
Aseptic Processes
Sterilization Processes
Cleaning Processes
Steam-in-Place Processes
Clean-in-Place Processes
Freeze-Drying Processes
Blow / Fill / Seal Process
Fermentation Processes
Barrier Technology
Media Fill Processes
Chemical and Testing
Laboratories
MedicalDevices
ManagementReview
Quality Systems and Gap
Assessments
Design Controls
Internal Auditing
Supplier Management
Systems
Assembly, Burn-in and
Release review
WIP, Laboratory, and Final
Release
Metrics, KPIs, and Statistical
Analysis
Complaints, CAPAs, and
Recall
QMS and Annual GMP
Training
Biologics&Biotech
Bioreactors
Isolators
Centrifugation
Aseptic Techniques
Clean rooms
Contract Lab and
Sterilizer Assessments
Change Management
Microbiology
Controls
BLA Submissions
ComputerSystems
BMS
LIMS
LANS / WANS
ERP (SAP, JDE, MAPICS)
PLC Systems
CalibrationData Base
Statistical Process Control
ProductExpertise
Pharmaceuticals, including:
•Oral Solids
•Liquids and Ointments
•Sterile (SVP, LVP) Products
Medical Devices
Medical Diagnostics
Biologics
APIs
Cosmetics

Protocol Link, Inc.
Regulatory Affairs Services
Regulatory Affairs
Management
Regulatory Submissions
eCTD Submissions
CDER, CBER and District Liaison
Life Cycle Management
Product Recall Management
DDMAC Marketing Materials
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Submissions & ESG
Manage
AssembleReview
Submit

Protocol Link, Inc.
Submissions & ESG
Submissions & ESG

Protocol Link, Inc.
Company Profile – Laboratory Services
Company Profile – Laboratory Services
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Protocol Link, Inc.
Regulatory Affairs
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Quality System

Protocol Link, Inc.
Documentation
QUALITY SYSTEMS
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Personnel
Training
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Compliance
Audits
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Compliance
Master Plan
Documents
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Documentation
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Validation
Methodology
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Change
Control
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Complaint
Handling
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Failure
Investigations
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Deviations /
Non-
conformance
Handling
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Product
Recalls
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Organization
and Personnel
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Annual Product
Review
Purchasing
Records
 Bill of Materials
(BOM)
 Incoming
Specifications
 Testing Procedures
 Certificate of Analysis
 Executed Master
Formula
 Executed IP / FP
Specifications
Testing
Records
Specification
Records
 Includes the principle,
equipment, reagents,
and procedural steps
fundamental and
essential for the test
procedure
 Includes validity and
acceptance criteria specific
to the application.
 Includes sample preparation
suitable for the test
procedure
 Information supercedes the
testing document
 Master Formulas
 In Process and
Finished Process
Specifications
 Testing Procedures
 Miscellaneous GMP
mandated produres
associated with all
record types
Manufacturing
Records
DMFs
Standard Operating
Procedures
cGMP Compliance
FDA Visit
PAI
Customer
Complaint
General GMP
Inspection
Inspection:
1. Documentation
2. Facilities/People
Negotiation / discussion
with company and
inspector
FD-483 report to
District Office
Company
Response
Reinspection or
Authorization /
Approval to Continue
Operations
Company Product
Recall
Warning Letter
(FDA witholds all
NDA Approval
Activities)
Seizures by
Federal
Marshalls
Consent Decree
of Permanent
Injunction
Prosecution Debarment
FDA
Actions

Protocol Link, Inc.
Out of Specifications (OOS)
Initiate Testing in
Accordance with
appropriate SOP
Analyst to Recieve
samples and
paperwork
Terminate testing
Procedural
deviation prior to
completion
Results within
Specifications?
Close testing and
report results
Yes No
Label OOS result
as an Invalid
Data Error
Identified?
Yes
Retesting
Identifies
Assignable
Cause
Yes
Lab Investigation
Phase I
(Worksheet)
Lab
Investigation
Phase II
(Worksheet)
Initiate Failure
Investigation per
pre-defined SOP
Initiate Deviation
Analyze all information
following execution of
complete investigation
Analyze data and review
results against specification
No
ROUTINE TESTING
OOS
Retesting Meets
Specifcations
No
No
Yes
Expand Investigation to
Review Batch
Process Non-
process Related
Errors ?
Yes
No
MRB
Dispositions Batch
Close Testing and
Report Results
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Audits
No. Section Sub Reference Description Expected cGMP Record(s)
Includes a
sequential line
number
Identifies Part
and Subpart
reference
Refers to the
paragraph reference
number
Describes title and/or
requirement of the
regulation as quoted
and/or interpreted
Lists key cGMP records
expected by the regulation
as applicable to the subject
pharmaceutical operation

Protocol Link, Inc.
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FDA 483s
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Trends in Enforcement
Our review shows these areas account for
over 50% of currentWarning Letter citations

Protocol Link, Inc.
Trends in Enforcement
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Number of Observations in 2013
Pharmaceuticals
Procedures not in writing, fully followed
Investigations of discrepancies, failures
Absence of Written Procedures
Scientifically sound laboratory controls
Written procedures not established/followed
Procedures for sterile drug products
155
131
106
99
77
76
690 483 Letters issued

Protocol Link, Inc.
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Medical
Device
Lack of / inadequate procedures
Lack of / inadequate complaint procedures
Documentation
Lack of / inadequate process validation
Lack of Written MDR Procedures
Purchasing controls, Lack of / inadequate procedures
378
245
133
127
124
110
1099483 Letters issued
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SOPs not maintained and followed
Failure to perform thorough investigations with
documentation
Failure to provide a complete history of the
work performed
Records not concurrently maintained with
performance of each significant step
Failure to maintain required processing records
Failure to submit timely biological product deviation reports
105
44
26
18
18
18
Biologics
191 483 Letters issued

Protocol Link, Inc.
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Drug Product Launch – Action
Plan
Drug Product Launch – Schedule

Protocol Link, Inc.
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Manufacturing Facilities
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Validation – Sequencing
Slide No. 40
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Risk-Based
Approach
Controlled Strategies
Process Done Right
Validation Master
Plan
Engineering
Turnover
Protocol Development
OQ
PQ
Field Execution Final Report
Instrumentation
Calibration
Released
for Use
SOP
Development
Personnel
Training
Change
Control
Mechanical Completion
Commissioning
Design
Specifications
Procurement
FAT / SAT
Delivery /
Installation
Project
Approval
Validation Protocol Development ProductionValidation Field Execution Validation Final Report
Revalidation/Requalification
Preventive
Maintenence
Planning
PPQ
OQ
PQ
PPQ
OQ
PQ
PPQ
IQ IQOQ

Protocol Link, Inc.
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Validation – Life Cycle
EQUIPMENT / SYSTEM VALIDATION LIFE CYCLE
DEFINE EQUIPMENT / SYSTEM QUALITY ATTRIBUTES
DEFINE SYSTEMS AND SUBSYSTEMS INCLUDING
PROCESSING TECHNOLOGIES, OPERATING
PARAMETERS AND CORRECTIVE ACTION FEATURES
TO MEET EQUIPMENT / SYSTEM QUALITY ATTRIBUTES
INSTALL NEW EQUIPMENT
AND SYSTEMS
IDENTIFY CRITICAL
PROCESS PARAMETERS
AND ESTABLISH
OPERATING RANGES
INSTALLATION
QUALIFICATION (IQ)
OPERATIONAL
QUALIFICATION (OQ)
PERFORMANCE QUALIFICATION (PQ)
ESTABLISH ALERT AND
ACTION LEVELS FOR KEY
QUALITY ATTRIBUTES
ESTABLISH CORRECTIVE
ACTION RESPONSES
PROSPECTIVE PHASE - CONFIRM
APPROPRIATENESS OF CRITICAL PROCESS
PARAMETER OPERATING RANGES
VALIDATION MAINTENANCE
CHANGE CONTROL
PERIODIC REVIEW
Equipment /
System
Changes or
Adjustments
Change
Change
Change
Validation – ERP System
SAP R/3
Team
Fix it Team
Integration
Test
Coordinator
Cycle Test
Leads
Documentation
Specialist
Testers
Implementation
Lead
.
.
Field Testing
(PQ)
Integration
& System
Testing
(IQ/OQ)
Unit and
Component
Ongoing System
Evaluation
Final Report
(Data Analysis and
Acceptance)
Define User
Requirements
Vendor Evaluation
and Selection
Functional Specification
(Design/Specify
Hardware/Software)
Software Quality
Assurance Plan or
Validation Plan
Testing
Change Control

Protocol Link, Inc.
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Validation – Process
Validation Strategy
"What we will do and
how we will do it"
Process Validation
Implementation!
Validation Plan
Formal Documentation
of "what we will do and
how we will do it"
Validation – Cleaning
Characterization
Studies
Master Plan
Validation
Protocol
Documented Cleaning
Strategy
Start
Ongoing
Monitoring
and
Revalidation
Execution
Master Document
Execution
Final Report
Reports
Cleaning Strategy
Document

Protocol Link, Inc.
Company-Wide Project Profile
Slide No. 45
20%
27%
16%
5%
1%
10%
11%
10% Compliance Management
Validation / Qualification
Quality Systems
Business Solutions
Training Programs
cGMP Documentation
Technical Services
Regulatory Affairs
Projects Worldwide
36%
27%
9%
9%
9%
5%
5%Medical Device
Compliance Management Validation/Qualification
Quality Systems Business Solutions
Training Program cGMP Documentation
Technical Services Regulatory Affairs
Project Profile By Product Type
Biologics
Pharmaceutical

Protocol Link, Inc.
Sample Projects Completed
Projects Worldwide

Protocol Link Company Profile

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