over years assisting industries in the validation and consulting service. 12 copyright (c) 1994-2007...

Over Years Assisting Industries in the Validation and Consulting Service. 12

Copyright (c) 1994-2007 TSRD All Rights ReservedCopyright (c) 1994-2007 TSRD All Rights Reserved

“ “ To satisfy our client’s validations To satisfy our client’s validations needs with a needs with a Time EfficientTime Efficient, , Cost Cost EffectiveEffective and and High Quality ServiceHigh Quality Service.”.”

Our organization of experienced technical and regulatory professionals will provide the most excellent quality validation services available.


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.


Project managementProject management PlanningPlanning ResourcesResources Quality ControlQuality Control

TrainingTraining Regulatory ComplianceRegulatory Compliance

cGMPscGMPs GLPGLP Part 11Part 11 QRSQRS ISO 9000, 13485 & 13488ISO 9000, 13485 & 13488 USP, EP, etc.USP, EP, etc.

Technical ComplianceTechnical Compliance

Technical UnitTechnical Unit Q/A ManagementQ/A Management Business UnitBusiness Unit

MarketingMarketing FinancialFinancial Account ReceivableAccount Receivable Customer ServiceCustomer Service


Our Experienced Staff will direct its resources in every project. Thus completing each project in an efficient and effective manner.

TSRDQuality Assurance

& Technical Support

TechnicalEvaluation

ClientValidation Project

TeamSchedule

ProjectScope

TSRDValidation Project Leader

& Validation Team

ValidationProject

Manager

ClientApproval

DocumentDevelopment

ClientEvaluation

IQ/OQ/PQEvaluation& Report

Based onDocumentation

Provided byClient or Contractor

Outside the Project Organization

Construction&

InstallationReferences

RegulatoryCompliance


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.


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.


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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


Company

Pa

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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


Company

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GlaxoSmithKline

Tyco HealthCare

Boehringer Ingelheim; contracted by AAC Consulting Group

Abbott Laboratories

PALL

Roche


2002 2003 2004

5,483 Hours

16,422 Hours

20,786 Hours

Our Standards in Quality has Lead us to Increase Working Hours Year after Year


2005

31,820 Hours

2006

24,154 Hours

Where:

Q = High Quality E = Experienced, Trained Personnel

r = Lower Rates t = Timely Service


over years assisting industries in the validation and consulting service. 12 copyright (c) 1994-2007...

Documents

rights reserved slide

consulting validation

management review

broad range of validation

quality management gmp

regulatory professionals

quality services auditing

regulatory consultant