Transcript TSRD Company Presentation

Over
12
Years Assisting Industries in the Validation and Consulting Service.
Copyright (c) 1994-2007 TSRD All Rights Reserved
“ To satisfy our client’s validations
needs with a Time Efficient, Cost
Effective and High Quality Service.”
Our organization of experienced technical and regulatory professionals
will provide the most excellent quality validation services available.
Copyright (c) 1994-2007 TSRD All Rights Reserved
A breakthrough in consulting & validation services in
Puerto Rico.
We are a Puerto Rican company, specializing in validation and
quality services ( Auditing, Regulatory Advise, CAPA, Investigation,
Management Review, Annual Product Review, others ) for the
pharmaceutical and medical devices industries.
Our experience covers a broad range of validation, regulatory,
manufacturing and quality services; from early product/process
development stage to full scale operation and certification.
We bring to each assignment a team of highly qualified personnel,
knowledgeable of the most recent regulatory, audit and technical
procedures.
Copyright (c) 1994-2007 TSRD All Rights Reserved
Technical Unit
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Project management
Planning
Resources
Quality Control
Q/A Management
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Training
Regulatory Compliance
 cGMPs
 GLP
 Part 11
 QRS
 ISO 9000, 13485 & 13488
 USP, EP, etc.
Technical Compliance
Copyright (c) 1994-2007 TSRD All Rights Reserved
Business Unit
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Marketing
Financial
Account Receivable
Customer Service
Construction
&
Installation
References
Regulatory
Compliance
Technical
TSRD
Quality Assurance Evaluation
& Technical Support
Based on
Documentation
Provided by
Client or Contractor
Project
Scope
Validation
Project
Manager
Document
Development
Schedule
Outside the Project Organization
TSRD
Validation Project Leader
& Validation Team
Client
Evaluation
Client
Validation Project
Team
Client
Approval
IQ/OQ/PQ
Evaluation
& Report
Our Experienced Staff will direct its resources in every project.
Thus completing each project in an efficient and effective manner.
Copyright (c) 1994-2007 TSRD All Rights Reserved
 Manufacturing Process
Parenterals Products (Aseptic Processing, Terminal Sterilized),
Solid Dosage, Semi Solid Dosage, Bulk Chemical, Medical
Devices (Class I, II & III ), Biotechnology Products and Aerosols.
 Methods & Laboratory
Analytical Methods, Laboratory Instruments, Management,
Microbiological Instrumentation Methods.
 Equipment
HVAC’s System, Process Equipment ( Parenterals, Solid & Semi
Solid Products, Aerosols, Liquids and Medical Devices )
Packaging ( I.e. Blister Machines, Labelers, Others ).
 Utilities
Water, Compressed Gases ( i.e. Air, Nitrogen ), Dust Collections
Systems, Cryogenic System, Refrigeration Systems.
 Control Systems
PLC’s, Integrity Testers, Building Management Systems,
Computer Validation Calibration & PM Management Systems.
Copyright (c) 1994-2007 TSRD All Rights Reserved
 Facilities
Clean and Controlled Rooms, Manufacturing,
Cleaning, Packaging, and Laboratories Facilities.
 Quality Management
Gmp Audits, Mock Inspections, ISO surveillance
program, Supplier Certification, Statistics, TQM, ISO
9000, 14885, 14888, Training / Seminars, Regulatory
Consultant.
 Sterilization Process
Sterilization Process for Parenterals Products and
Medical Devices (ETO, Dry Heat, Moist Heat, Radiation,
and Filtration), SIP.
 Other Processes
Component Preparations, Cleaning Validation, CIP.
Copyright (c) 1994-2007 TSRD All Rights Reserved
Warner Lambert, Inc.
(Actually Pfizer)
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Parke-Davis Pharmaceuticals
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OMJ Pharmaceuticals
Janssen Pharmaceuticals
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MFG Process
Equipment
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SOPs Development
Facilities
Packaging
Training
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Computers
Cleaning
Calibrations
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Lilly Del Caribe, Inc. (Mayagüez)
Mentor Caribe
(Actually, CIBA Vision)
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Ocular Sciences Puerto Rico, Inc.
(Actually Cooper Vision)
Schering Plough Pharmaceuticals
Assessments
Laboratories
HVACs
Utilities
Sterilization
Chemical
Medical Devices
Solid Dosage
Parenterals
Company
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Copyright (c) 1994-2007 TSRD All Rights Reserved
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Reedco and Dentco, Inc
Zimmers, Inc.
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Allergan
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PACO, Inc.
Life Scan
Eli Lilly
Warner Chilcott
Cardinal Health
MFG Process
Equipment
SOPs Development
Facilities
Packaging
Training
Computers
Cleaning
Calibrations
Assessments
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Amgen, Inc.
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Sartorious, Inc.
Laboratories
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ElectroBiology
HVACs
Utilities
Sterilization
Chemical
Medical Devices
Solid Dosage
Parenterals
Company
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Heyer-Shulte NeuroCare (Actually,
Integra NeuroSciences P.R. Inc.)
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Guidant
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Copyright (c) 1994-2007 TSRD All Rights Reserved
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Abbott Laboratories
Roche
GlaxoSmithKline
Tyco HealthCare
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Boehringer Ingelheim; contracted
by AAC Consulting Group
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PALL
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Copyright (c) 1994-2007 TSRD All Rights Reserved
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MFG Process
Equipment
SOPs Development
Facilities
Packaging
Training
Computers
Cleaning
Calibrations
Assessments
Laboratories
HVACs
Utilities
Sterilization
Chemical
Medical Devices
Solid Dosage
Parenterals
Company
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31,820 Hours
24,154 Hours
20,786 Hours
16,422 Hours
5,483 Hours
2002
2003
2004
2005
2006
Our Standards in Quality has Lead us to Increase Working Hours Year after Year
Copyright (c) 1994-2007 TSRD All Rights Reserved
Where:
Q = High Quality
E = Experienced, Trained Personnel
r = Lower Rates
t = Timely Service
Copyright (c) 1994-2007 TSRD All Rights Reserved