latino america consultores company profilelatino america consultores company profile update 2018,...

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]

https://www.google.com.ar/maps/preview?ie=UTF8&cid=16694106258590262024&q=Latino+Am%C3%A9rica+Consultores&iwloc=A&gl=AR&hl=es

mailto:[email protected]

Doc. Code: LAC_CP_2018 Version 1.0. Period: 2018, January

Doc. Title: Latino America Consultores Company Profile

LAC_Company Profile_2018_1.0_eng Pagina 2 di 25

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




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




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




Temmler 25 LAMP (2018) 25




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.




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 .




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.




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




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



http://www.latconsultores.com.ar/




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




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




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

http://www.latconsultores.com.ar/novedades.asp




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

http://www.latconsultores.com.ar/upload/TrazabilidaddelosProductosFarmac%C3%A9uticos.pdf

http://www.latconsultores.com.ar/upload/2ModAvailableTechnologies.pdf




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




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)




GMP Consultancy


GMP Consultancy

Registration of a new laboratory in Argentina and transference of BMS products to Mead Johnson.


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




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)




3.3. Business Development Support & International Regulatory Support

Training

Business Development Activities

International Regulatory Affairs

Extended GMP Consulting Activities

Business Development Support


Partner Identification

Alliance Management




Partner Identification

Alliance Management



Finadiet

(Buenos Aires)

Holliday Scott

(Buenos Aires)

Kilab

(Buenos Aires)

LKM

(Buenos Aires)

Mead Johnson

(Buenos Aires)

Microsules

(Buenos Aires)




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


Validation Master Plan Preparation

Conceptual & Feasibility Design

Introduction

Andromaco (2016

Grunenthal Formenti

Chile)

Kilab

(Buenos Aires)

LABYES

(Buenos Aires)





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)


Product Strategic Analysis

Conceptual & Feasibility Study

Engineering, Qualification & GMP Support

GMP Assessment

GMP Review

Value Engineering

Qualification & Validation

GMP Consultancy

Equipment Validation


GMP Consultancy

Software validation

Purified Water System Validation

Regulatory Affair Support

Cleaning Validation 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)




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




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)




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)




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)