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Over Years Assisting Industries in the Validation and Consulting Service. 12 Copyright (c) 1994-2007 TSRD All Rights Reserved.

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Presentation on theme: "Over Years Assisting Industries in the Validation and Consulting Service. 12 Copyright (c) 1994-2007 TSRD All Rights Reserved."— Presentation transcript:

1 Over Years Assisting Industries in the Validation and Consulting Service. 12 Copyright (c) TSRD All Rights Reserved

2 “ 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) TSRD All Rights Reserved

3 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) TSRD All Rights Reserved

4  Project management  Planning  Resources  Quality Control  Training  Regulatory Compliance  cGMPs  GLP  Part 11  QRS  ISO 9000, &  USP, EP, etc.  Technical Compliance Technical Unit Q/A Management Business Unit  Marketing  Financial  Account Receivable  Customer Service Copyright (c) TSRD All Rights Reserved

5 Our Experienced Staff will direct its resources in every project. Thus completing each project in an efficient and effective manner. TSRD Quality Assurance & Technical Support Technical Evaluation Client Validation Project Team Schedule Project Scope TSRD Validation Project Leader & Validation Team Validation Project Manager Client Approval Document Development Client Evaluation IQ/OQ/PQ Evaluation & Report Based on Documentation Provided by Client or Contractor Outside the Project Organization Construction & Installation References Regulatory Compliance Copyright (c) TSRD All Rights Reserved

6   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) TSRD All Rights Reserved

7   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) TSRD All Rights Reserved

8 Parenterals Solid Dosage Medical Devices Chemical Sterilization Utilities HVACs Laboratories Assessments Calibrations Cleaning Computers Training Packaging Facilities SOPs Development Equipment MFG Process Parke-Davis Pharmaceuticals Warner Lambert, Inc. (Actually Pfizer) OMJ Pharmaceuticals Janssen Pharmaceuticals Ocular Sciences Puerto Rico, Inc. (Actually Cooper Vision) Schering Plough Pharmaceuticals Lilly Del Caribe, Inc. (Mayagüez) Mentor Caribe (Actually, CIBA Vision) Company Copyright (c) TSRD All Rights Reserved

9 Company Parenterals Solid Dosage Medical Devices Chemical Sterilization Utilities HVACs Laboratories Assessments Calibrations Cleaning Computers Training Packaging Facilities SOPs Development Equipment MFG Process Reedco and Dentco, Inc ElectroBiology Zimmers, Inc. Allergan PACO, Inc. Life Scan Sartorious, Inc. Amgen, Inc. Eli Lilly Warner Chilcott Cardinal Health Heyer-Shulte NeuroCare (Actually, Integra NeuroSciences P.R. Inc.) Guidant Copyright (c) TSRD All Rights Reserved

10 Company Parenterals Solid Dosage Medical Devices Chemical Sterilization Utilities HVACs Laboratories Assessments Calibrations Cleaning Computers Training Packaging Facilities SOPs Development Equipment MFG Process GlaxoSmithKline Tyco HealthCare Boehringer Ingelheim; contracted by AAC Consulting Group Abbott Laboratories PALL Roche Copyright (c) TSRD All Rights Reserved

11 ,483 Hours 16,422 Hours 20,786 Hours Our Standards in Quality has Lead us to Increase Working Hours Year after Year Copyright (c) TSRD All Rights Reserved ,820 Hours ,154 Hours

12 Where: Q = High Quality E = Experienced, Trained Personnel r = Lower Rates t = Timely Service Copyright (c) TSRD All Rights Reserved


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