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LATINO AMERICA
CONSULTORES
COMPANY PROFILE
Update 2018, January
Version 1.0
Latino America Consultores - Alsina 249, 3°cuerpo 3°A-San Isidro-CP 1642 – Buenos Aires +54 11 4707 0239 / +54 11 4743 4898 - www.latconsultores.com.ar - [email protected]
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Document Control
Version Data Author Issue’s Reasons
1.0 (2014)
January, 2014 G. Rossi 1st Review 2014
2.0 (2014)
February, 2014 G. Rossi 2nd Review 2014
3.0 (2014)
March, 2014 G. Rossi 3rd Review 2014
4.0 (2014)
April, 2014 G. Rossi 4th Review 2014
5.0 (2014)
June, 2014 G. Rossi 5th Review 2014
6.0 (2014)
June, 2014 G. Rossi 6th Review 2014
7.0 (2015)
July, 2015 G. Rossi 1st Review 2015
1.0 (2016)
April, 2016 G. Rossi 8th Review – 1st Review 2016
2.0 (2016)
April, 2016 G. Rossi 9th Review – 2nd Review 2016
3.0 (2016)
December, 2016 G. Rossi 10th Review – 3rd Review 2016
4.0 (2016)
December, 2016 G. Rossi 11th Review – 4th Review 2016
1.0 (2017)
June, 2017 G. Rossi 12th Review – 1st Review 2017
1.0 (2018)
January, 2018 G. Rossi 13th Review – 1st Review 2018
Version Control
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Contents
Document Control 2
Contents 3
1. Latino America Consultores Overview 6
1.1. Company Operation 7
1.2. International Collaboration 8
1.3. Regional Regulatory Affair Support 9
1.4. Additional Services and Methodology 10
1.5. Address 10
2. Latino America Consultores – Main References 11
2.1. South America References 11
2.2. Cooperation in European Project 12 Italy 12 Portugal 12 Spain 12 UK 12
2.3. Middle East – Nord Africa 12
2.4. Events, Technical Seminars & Public Conferences 13 2008 13 2009 13 2010 13 2011 14 2012 14 2015 14 2016 14 2017 14 2018 15
3. Process & Quality Services 16 Introduction 16
3.1. Regulatory Affairs 16 Bago 16 Bristol Myers Squibb (Buenos Aires) 16 Laboratorios BAGO (Buenos Aires) 16 LABORATORIO CASASCO (Buenos Aires) 16 LABORATORIO CASARA (Buenos Aires) 17 MEAD JOHNSON (BMS Buenos Aires) 17 Laboratorios MONTPELLIER (Buenos Aires) 17
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3.2. Quality Assurance Process Qualification & GxP Support 17 ELEA (Buenos Aires) 17 Laboratorio Dorrego (Montevideo) 17 Laboratorio Omega 17 Novartis Chile (2017/2018) 18 Pierre Fabre (Buenos Aires) 18 Quimica Montpellier (Buenos Aires) 18 Syntex (Buenos Aires) 18
3.3. Business Development Support & International Regulatory Support 19
Finadiet (Buenos Aires) 19 Holliday Scott (Buenos Aires) 19 Kilab (Buenos Aires) 19 LKM (Buenos Aires) 19 Mead Johnson (Buenos Aires) 19 Microsules (Buenos Aires) 19
4. Engineering & Validation 20 Introduction 20 Kilab (Buenos Aires) 20 LABYES (Buenos Aires) 20 Laboratorio Ariston (Buenos Aires 2012 - Current) 21 Laboratorio Dispert (Uruguay) 21 Laboratorio Omega 21 Laboratorio Kemex 21 Laboratorio Raymos (Buenos Aires) 21 Mead Johnson (Buenos Aires) 21 Mega Pharma (Uruguay 2013-current) 22 Mead Johnson 22 OCASA (New York, Buenos Aires, Mexico, Panamá, Bogota, Lima, Sao Paolo, India 22
4.1. Biotechnology 22 Biosidus 22
5. Compliance IT (& Automation) 23 Introduction 23 Abbott 23 AMEGA Biotech GEMA Biotech (Buenos Aires 2012-2013) 23 Antibioticos 24 Antibioticos (Leon) 24 Clausen (2018) 24 Eriochem (2018) 24 Laboratorio Hidalgo (Buenos Aires) 24 Laboratorio Teteur (2018) 24 Laboratorio Raymos (2018) 24 Mega Pharma 2015 - 2016 25 Mega Pharma 2017 25 Mega Pharma 2018 25 OCASA (Buenos Aires 2012-2015) 25 Raymos (2013-2018) 25 Rovafarm 25
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Temmler 25 LAMP (2018) 25
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1. Latino America Consultores Overview
Latino America Consultores since its foundation, had worked in cooperation with International Partners, to be able to integrate the local competences with the once of the International Partners, to supply the most adequate support to all the Customer located in Centre and South America.
The work methodology, the international network and the acquired experience allows Latino America Consultores to provide an International State of the ART support in terms of Approach, Methodology and Technologies.
Founded in 2008, to support Customer’s Project in Both, local (ANMAT) and cGMP/EU-GMP Regulated Environment, in only 6 years of continuous activity has become one of the Regional Leading GMP Consultancy Company.
Following the market requirements evolution, for GMP Regulatory and GMP Production Compliance, LAC could provide customer support covering the following areas:
R&D – Research & Development
Business Modelling & Business Process Re-Engineering
Company (&corporate) organization, support Process change and Structure changes
Technology Transfer
Engineering
Industrial Process Qualification
Supply Chain Optimisation
Information Technology – System Integration, Infrastructure Management & Optimisation, IT Compliance
Regulatory Compliance Support
Quality assurance & Quality Control
Our experts’ team incorporates a wide range of skills, providing coverage to manage all stages of product life cycle in compliance, for Production, Quality Process and Business Development.
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1.1. Company Operation
LAC - Latino America Consultores count on Team of consultant, using a standard methodology, including Process Mapping Tools, Risk Analysis Tools, reporting tools.
The LAC Staff is organised as a Group of Project Manager, who can individually control the external contractor team or the Customer’s Team/Resources; the main expertise is focused on the following services areas:
Process Design & Process Validation
Scale Up & Technology Transfer Support
Strategic Business Support (Production Strategy, Product Portfolio Management)
Quality Assurance & GMP Process Support Auditing
Regulatory (National & International)
Process Qualification
Value Engineering & Validation
Feasibility & Conceptual
Design & Engineering Support
Revamping
Third party Design Qualification
Qualification support for Utilities & Plant, Support for Process Automation)
System Integration & Compliance
IT & Compliance Consultancy
System Integration
Computer System Validation
GMP Compliance Infrastructure Management
Through its own expertise LAC is able to support all needs of customers in terms of product life cycle steps, from formulation to finished products release, in compliance with international requirements;
Qualities by Design & Risk Management are the bases of our internal methodology and project management behaviour.
LAC operates supporting Multinational Pharmaceutical Organisation, National & Local Pharmaceutical Company, API Producer and Contract Manufacturers. LAC - Latino America Consultores has its own office in Buenos Aires, and Uruguay, offering a full coverage to all the Latino American Countries; with the regional partners LAC can Operate in all Sur America, including Brazil, Paraguay, Uruguay, Chile, Bolivia, Peru, Ecuador and Colombia .
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1.2. International Collaboration
Thanks to International Partners, Latino America Consultores represent a “worldwide network” that can operate in each part of the world, and can offering shared competencies at International Level.
For “Extended Project” as feasibility studies, Engineering, Technology Transfer, Latino America Consultores could provide not only Consulting Services but a strong support in Customer’s Projects, from Partners & Provider Selection to Engineering and Validation Support.
With the partner’s network, Latino America Consultores could act as a Strategical Solution Provider:
Due to its specific activity, Latino America Consultores normally act as Project Coordinator, assuring Project’s GMP Compliance and involving different local and international partners depending by Project Location and project specific knowledge requirements.
For this reason Latino America Consultores selects the most skilled partner and Subject Matter Expert for the project target, for example finished product, API or Vaccines Plant Project.
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1.3. Regional Regulatory Affair Support
Latino America Consultores, could also provide a Regional Regulatory Affair Support within South America Region.
Through our local partner, or with direct local collaborator, Latino America Consultores could provide regulatory services support in:
Argentina – Latino America Consultores
Brazil – Direct Collaborator;
Chile – Direct Collaborator
Uruguay – Direct Collaborator
Paraguay – Local Partner Office
Peru - Local Partner Office
Ecuador - Local Partner Office
Colombia - Local Partner Office
Direct Presence or Direct Collaborator
Local Partner
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1.4. Additional Services and Methodology
Since its foundation in 2008 LAC can provide a network of International partners supporting strategic operation, regulatory / licensing and Strategic Consulting.
Actually LAC is involved in International projects concerning:
Internal Business Process Re-engineering (Strategic, Operation, Process Optimisation, QA/Quality Management System, GMP Review, LEAN, SWAT)
Technology Transfer Support (Internal from R&D to Production &/or between different sites)
Regulatory Support (Strategic for Product & Standard for Dossier Registration & Variations)
The internal Methodology is inspired and aligned to the last requirements and Guide Line, using a Quality by Design (QbD) and Risk Based Approach from Feasibility & Design to Qualification (ICH-Q8, ICH – Q9 ICH-Q10, GAMP®5).
1.5. Address
Latino America Consultores Alsina 249 3° cuerpo 3°A-San Isidro -CP 1642
Buenos Aires
Tel/Fax +54 11 4707 0239 / +54 11 4743 4898
LACyT SRL Colonia 810 – Apto 901 Città Montevideo
Uruguay
Email [email protected] Web http://www.latconsultores.com.ar
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2. Latino America Consultores – Main References
Following a summary of the principal LAC’s References divided by region.
2.1. South America References
Andromaco
Biosidus
Bago
BMS
ELEA
Finadiet
Gema Biotech
Grunenthal Formenti
Holliday Scott
Inghenia
Kilab
Laboratorio Ariston
Laboratorio Casara
Laboratorio Casasco
Laboratorio Dorrego
Laboratorio Hidalgo
Laboratorio Kemex
Laboratorio Omega
Laboratorio Raymos
Laboratorios Dispert SA
LABYES
LKM
Mead Johnson
Mega Pharma
Microsules
Montpellier
OCASA
Pierre Fabre
PharmADN
Rovafarm
Syntex
Introduction
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2.2. Cooperation in European Project
Human Bioplazma KFT
Richter Gedeon (Gedeon Richter)
Teva
Abbott
Antibioticos
Astellas
Aventis
Kedrion
Janssen-Cilag
Novartis
Patheon
PMI
Recordati
Temmler
Yamanouchi
Wyeth
Zambon
Lusomedicamenta (ex. Janssen-Cilag)
Antibioticos Leon
Merck Sharp & Dohme
SGS Wokingham
2.3. Middle East – Nord Africa
Medis(Tunisia)
Remede Pharma (Algeria)
Hungary
Italy
Portugal
Spain
UK
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2.4. Events, Technical Seminars & Public Conferences
For more information, please visit Latino America Consultores Web-site:
http://www.latconsultores.com.ar/novedades.asp
ETIF 2008 - Conferences:
Pharmaceutical Utilities
GAMP® 5 Overview
Risk Based EBRS Implementation using GAMP® 5
Contamination control according to Annex I
Pharmaceutical Technology - Technical Publication:
o Exporting in Europe
o Annex I EU-GMP
CILFA – Conference: European Market
Sindusfarma: Computer System Validation & GAMP® 5
Universidad de Belgrano – Conference: Computer System Validation
Gobierno de la Ciudad de Bs. As.: Conference Cycle related to:
o International Pharmaceutical Exportation Rules for Pharmaceutical Product
o European Registration
Gobierno de la Ciudad de BsAs: Supporting launch of Foreign Trade Database;
Universidad de Belgrano – Conference – Product Traceability – Overview of International On-Going Regulation & Project
Sindusfarma – Conference: Product Traceability – Overview of International On-Going Regulation & Project (Control de Autenticidad y Trazabilidad de Medicamentos)
ETIF 2010:
o Participation to the 1st “Ronda de Negocio”
o Conference: CTD and Regional Variations of CTD
o Conference: MENA and (Caspian región or east Europe) pharmaceutical markets and regulations
o Conference: International and ANVISA tracealibility requirements, en el marco del Congreso ETIF 2010
o Pharmaceutical Technology Magazine - Technical Publication: Trazabilidad de Medicamentos;
2008
2009
2010
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ExpoFybi 2011:
o Conference: Trazabilidad de los Productos Farmacéuticos
o Conference: Available Technologies
o Participation to “Ronda de Negocio – ExpoFybi – 2011”
Sindusfarma – 2nd Workshop Conference: Product Traceability – Overview of International On-Going Regulation & Project – 2011 Updates
Gobierno de la Ciudad de Bs. As. – Conferencias:
o Aspectos Regulatorios Internacionales
o Seminario sobre Requisitos para la Exportación EMEA/FDA
ETIF 2012:
o Conference: Conferencia Validación de SAP: Su impacto en el Desarrollo del Negocio
o Participation to “Ronda de Negocios – ETIF 2012”
“Algo está cambiando en el mundo farmacéutico 2014-2015
o Universidad de Palermo en cooperación con el Gobierno de la Ciudad de Buenos Aires, CEDEX, BAcomex y SindusFarma;
o Updates on International Tendencies;
o Annex15 EMA;
ETIF 2016:
o Exhibitor for the launch of the new line of Services - LAC Compliance and Process IT Solutions, providing IT Solution for regulated environments;
o Conference: “Como Integrar el ERP Corporativo con Aplicaciones MES para Batch Record Electrónico y Data Integrity”;
o Conference: “Nuevas Tendencias Relacionadas con EU GMP Annex 15, Data Integrity y Governance”;
o Conference: “Flujo Integrado de Procesos Documentales a través de un Sistema Informático (DMS)”.
Facultad de Química de la Universidad de Uruguay (entrenamientos dictados)
o "Nuevo Enfoque para la Validación de Software e Integridad de datos” (24 Julio 2017)
o "Administración del Análisis de Riesgo" (21 Agosto 2017)
A la pagina siguiente
2011
2012
2015
2016
2017
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Sigue de la página anterior
Expofybi Exposición y Congreso de Internacional de Farmacia y Bioquímica (entrenamientos dictados)
o Análisis de Riesgo aplicado a la Validación de Sistemas
Expofarma Uruguay
o Buenas Practicas para la Integridad de Datos
Ministerio de Salud Pública de Uruguay División Fiscalización
o Capacitación en Herramientas y Administración del Riesgo DIC-2017
58° Simposio AFI – (in cooperation con PTM Consulting):
o Knowledge management: un approccio innovativo alla mappatura e alla gestione delle informazioni di processo (Knowledge Management – un enfoque innovador para mapear y administrar la información del proceso)
o Pharma 4.0 e Data Integrity: combinar las tendencias emergentes con los desarrollos de TI y los requisitos de integridad de datos
Ministerio de Salud Pública de Uruguay División Fiscalización
o Nuevo Enfoque para la Validación de Software e Integridad de datos
2018
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3. Process & Quality Services
This expertise may support implementation, review of Quality related issues, and related Quality System Project for daily activities, including Regulatory Services.
As a brief overview, the main QA and GMP Process services supplied are:
Auditing
Regulatory Affair
GMP and GLP Support & GMP Review
Process & Impact Assessment
Support for Technology Transfer
Managing, Reviewing and Submit Regulatory Documents (CTD, eCTD, APR, QPR, EBR)
Support for Quality Management System Implementation & Review
Support for Authorities Inspection
Supplier & Raw material Qualification
In House Training
Public Training
3.1. Regulatory Affairs
International Regulatory Affairs and GMP Trends training.
GMP Consultancy
Training
Regulatory Affairs Support
GMP Consultancy
Training
GMP Consultancy
International Regulatory Affairs training.
Introduction
Bago
Bristol Myers
Squibb (Buenos
Aires)
Laboratorios
BAGO (Buenos
Aires)
LABORATORIO
CASASCO (Buenos Aires)
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GMP Consultancy
International Regulatory Affairs and GMP Trends training.
GMP Consultancy
Registration of a new laboratory in Argentina and transference of BMS products to Mead Johnson.
International Regulatory Affairs and GMP Trends training.
3.2. Quality Assurance Process Qualification & GxP Support
Risk Assessment
Risk Assessment Training
Risk Assessment (2016)
Supporting Sterile Qualification (2016)
Supporting Media Fill Qualification (2016)
Supporting User’s Risk Assessment Training (2016)
Supporting Validation Mater Plan for Aseptic Production (2017)
Aseptic Process Validation (2017)
Supporting Preparation for Start Up and Media Fill tests (2017)
SIP/CIP Systems Validation (2018)
Assessment
Supporting Quality Management System Review and New Quality Management System Implementation
International GMP Audits and Consultancy.
European GMP Consultancy for veterinary food products
LABORATORIO
CASARA (Buenos Aires)
MEAD
JOHNSON (BMS
Buenos Aires)
Laboratorios
MONTPELLIER (Buenos Aires)
ELEA
(Buenos Aires)
Mega Pharma
(2016 Uruguay)
Laboratorio
Dorrego (Montevideo)
Laboratorio Omega
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Distribution Container System Validation (2017)
Customised Container System Development Support (2017)
End User Container System Validation (2018)
GMP Consultancy
Process Validation
GMP Consultancy
Training
Risk Assessment Training
Reviewing Cleaning Validation Master Plan (2017)
Preparing and Executing Cleaning protocols for multiple systems (2017)
Filling Line Depyrogenation Tunnel Qualification
Risk Analysis and Purified Water Systems Qualification (2018)
GMP Consultancy
Training
Supporting Business Development
Novartis Chile (2017/2018)
Pierre Fabre
(Buenos Aires)
Quimica
Montpellier
(Buenos Aires)
PharmADN
Raymos
Syntex
(Buenos Aires)
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3.3. Business Development Support & International Regulatory Support
Training
Business Development Activities
International Regulatory Affairs
Extended GMP Consulting Activities
Business Development Support
Business Development Activities
Partner Identification
Alliance Management
Business Development Activities
International Regulatory Affairs
Business Development Activities
Partner Identification
Alliance Management
Business Development Activities
International Regulatory Affairs
Finadiet
(Buenos Aires)
Holliday Scott
(Buenos Aires)
Kilab
(Buenos Aires)
LKM
(Buenos Aires)
Mead Johnson
(Buenos Aires)
Microsules
(Buenos Aires)
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4. Engineering & Validation
This Expertise may support Design, Project Management, Construction, Commissioning, Qualification, Revamping & Maintenance engineering activities related to Plant and Equipment.
As a brief overview, the main topics covered are:
ENGINEERING
Basic & Conceptual Design
Value Engineering
Project Management
Start-up & Commissioning
QUALIFICATION &VALIDATION
Impact Assessment
Validation Master Plan
Design Qualification
Installation Qualification, Operational Qualification, Performances Qualification
GAP Analysis
Remediation Program Support
Calibration & Maintenance
Warehouse Environmental Monitoring
Supply Chain Control Implementation
Engineering & GMP Support
GMP Plant Assessment
Supporting Critical Utilities Equipment and System Validation
Supporting Plant Engineering and refurbishing Activity
Supporting Supplier’s FAT
GMP Consultancy
Supporting Conceptual Analysis for new Plant Project
Engineering & GMP Support
Validation Master Plan Preparation
Conceptual & Feasibility Design
Introduction
Andromaco (2016
Grunenthal Formenti
Chile)
Kilab
(Buenos Aires)
LABYES
(Buenos Aires)
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Engineering & GMP Support
GMP Plant Assessment
Supporting Equipment and System Validation
Supporting Plant Engineering and refurbishing Activity
Support Various Plant Refurbishing Plans
Feasibility Study and URS preparation for Solid Plant 2017
Procurement Management and Tender Preparation
Basic Design, supporting construction phase, supporting building management coordination (2017-2018)
Engineering & GMP Support
Product Strategic Analysis
Conceptual & Feasibility Study
Engineering, Qualification & GMP Support
GMP Assessment
GMP Review
Value Engineering
Qualification & Validation
GMP Consultancy
Equipment Validation
Engineering, Qualification & GMP Support
GMP Consultancy
Software validation
Purified Water System Validation
Regulatory Affair Support
Cleaning Validation Support
Engineering, Qualification & GMP Support
Conceptual design
Advanced Basic Design
Procurement
Laboratorio
Ariston (Buenos Aires
2012 - Current)
Laboratorio
Dispert (Uruguay)
Laboratorio Omega
Laboratorio Kemex
Laboratorio
Raymos (Buenos
Aires)
Mead Johnson
(Buenos Aires)
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GMP Consultancy
Quality Management System Software Validation
Design Qualification Support for the New Plant
Full Equipment and Process validation of aseptic production (injection & ophthalmic)
Validation Master Plan preparation for Aseptic facilities
Media Fill design & support on execution
Support for International Audits
Supporting Plant Engineering change management (2018)
Risk Analysis for new installation (computer room infrastructure and critical utilities) (2018)
New QC Facilities
Conceptual Design
Cost evaluation
GMP review
URS definition
Suppliers evaluation and coordination
Project Management
Commissioning
Qualification & Validation
Supporting the Customer in:
Cold Chambers temperatures Mapping;
Cold Chain Validation
HVAC Qualification
Cold Chambers Qualification
GMP Qualification:
o GCP / GMP Impact Assessment;
o Supporting QMS update v/s GMP Operations
4.1. Biotechnology
Risk Analysis for Upstream and Downstream/las in preparation for international Audits
Mega Pharma
(Uruguay 2013-current)
Mead Johnson
OCASA
(New York,
Buenos Aires, Mexico,
Panamá, Bogota, Lima,
Sao Paolo, India
Biosidus
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5. Compliance IT (& Automation)
This expertise may support IT Project in Regulated Environment as Pharmaceutical, for both, Compliance/Validation Issues and Information Technology.
As a brief overview, the main services supplied by IT to Compliance Area are:
Feasibility Studies
URS definition
Supplier Qualification & Support for Software Selection
GMP & System Risk Assessment
Project Management
Computer System Validation
21 CFR Part11 Compliance
Remediation Program Support
Providing GMP Compliant Solution
Trainings
Support for IT Infrastructure Management (ref.: ISO 20000, ITIL, BSI-7799)
IT Networks Qualification
Feasibility study BPCS 6.004 version validation
GMP Training
CSV Training
21CFR11 Training Session
21 CFR Part 11 DCS Assessment and Remediation Plan Definition
GMP Assessment for the shop floor control system
Automatic Machines Validation
BPCS Upgrade Validation (2004) (2007)
Totalchrome Validation (upgrade – 2002 –2004)
GMP Site Risk & Process Analysis
SCADA Validation (2007)
Plant GXP Assessment for Computerised System
Validation Master Plan for Computer System Validation
Execution of Computer System Validation and 21 CFR Compliance Project
Introduction
Abbott
AMEGA
Biotech GEMA Biotech (Buenos Aires
2012-2013)
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LIMS validation (2003/2004)
QC Remediation (2007)
Empower Validation (2007)
Process Automation Assessment
Risk & GAP Analysis
Remediation Plan
DCS Validation (2003/2004)
Risk Analysis and Software Validation Master Plan
Validation of Software System for: Electronic Document Management Deviation Management Change Management Internal Audits
21 CFR Part 11, GAMP®5 and Computerised System validation Training
Project Assessment Supporting System’s implementation Compliance Activities Computerised System Validation Support
Legacy ERP system validation
ERP Microsoft Dynamic Axapta Validation
Antibioticos
Antibioticos (Leon)
Clausen (2018)
Eriochem (2018)
Laboratorio
Hidalgo (Buenos
Aires)
Laboratorio
Teteur (2018)
Laboratorio
Raymos (2018)
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2016 Computerised System’s Assessment Process Mapping & Full Risk Assessment Supporting Customer in Validation Strategy Development for
Integrated ERP (MS® Axapta, WMS & Dispensing) Managing Corrective Actions Managing Integrated ERP System Validation (MS® Axapta 2009) Mettler Weighing Rooms Systems Validation Validación and
Integration Weiging Rooms with Axapta (2016) Corporate ERP Change Control Management VMP update
Automatic MECALUX WareHouse System (2017) ABB xA800 SCADA System Validation (2017-2018)
Ampoules Inspection Analysis - Software system Validation Risk Analysis and Software validation Master Plan Category 4 and 5 Software System Validation ERP Change Management Support
Training Process Mapping SAP System Functional Assessment Supporting Implementation of Corrective Actions SAP Validation - Modules Validated: SD, WM, MM e PP
DMS Validation Validation of Temperature Monitoring System PLCs Validation Temperature Monitoring System Validation (2018)
GMP Consultancy Training Project Assessment Software Validation
Wireless Warehouse System Validation (2004) Dispensing System Update Validation Support 21CFR Part 11 International Assessment Program Support SAP vers. 6.0 Porting Validation Empower Validation
(Cooperating with PTM Consulting) SAP – ATTP (Advanced TracK&Trace for Pharmaceutical):
supporting implementation and Validation Phase of the SAP Module used to manage Serialisation (L3)
Mega Pharma
2015 - 2016
Mega Pharma
2017
Mega Pharma
2018
OCASA
(Buenos Aires 2012-2015)
Raymos (2013-2018)
Rovafarm
Temmler
LAMP
(2018)