Lugan Consulting

PHARMA QUALITY SYSTEM

AUDIT – SUPPORT – TRAINING –
PHARMACEUTICAL AND COSMETICS INDUSTRIES

LUGAN CONSULTING has proven expertise in the pharmaceutical and cosmetics industries. In addition to our experience, we constantly monitor the biopharmaceutical and pharmaceutical chemical sectors. This enables us to keep abreast of the specific features of these fields, developments in their markets and the standards and legislation that govern them. We provide audit, consultancy, support and training services tailored to the specific needs of companies producing pharmaceutical products.

PHARMACEUTICAL EXPERTISE

MASTERY OF SUBJECTS SPECIFIC TO THE PHARMACEUTICALS AND COSMETICS CHAIN

expertise pharmaceutique

Our specialisation in pharma enables us to deal effectively with the specific issues facing professionals in the sector. More specifically, we are experts in the drug manufacturing chain and deal with subjects inherent in the industrial processes of pharmaceutical and cosmetic production.

Benefit from an outside expert’s eye.

NOS SUJETS D'EXPERTISE​

Bonnes Pratiques de Fabrication : audit et formations
GOOD MANUFACTURING PRACTICE
Apprenez à gérer le changement
CHANGE MANAGEMENT
Audit de qualité pharmaceutique
PHARMA QUALITY MANAGEMENT
Gestion des CAPA
CAPA MANAGEMENT
Data integrity
DATA INTEGRITY
Gestion des déviations
DEVIATION MANAGEMENT

Choose expert support,

thanks to our pharma-specific services.

AUDITS OF PHARMACEUTICAL COMPANIES

ANALYSIS OF MANUFACTURING PROCESSES FOR PHARMACEUTICAL PRODUCTS

The pharmaceutical industry faces a wide range of challenges, including innovation, pricing and emerging markets. Meeting these challenges, while maintaining performance, requires certain obstacles to be overcome. So when a production facility is faced with these issues, an internal audit can be beneficial. To meet the specific needs of healthcare manufacturers, LUGAN CONSULTING has extended its consulting and auditing services to the pharmaceutical sector.

Audits pharmaceutiques

Consult a specialist in your field.

PHARMA​ AUDITS

Audit de système qualité
QUALITY SYSTEM

This ICQH10 audit assesses the compliance of industrial structures with the global model of the pharmaceutical quality system. It includes a detailed review of Good Manufacturing Practices (GMP).

Gestion des risques et qualité
QUALITY RISK

Our quality risk audit measures risk management according to the ICH Q9 standard, to ensure the safety, reliability and conformity of the products or services supplied by the production unit.

Adit des fournisseurs et des sous-traitants
SUPPLIER AUDIT

This analysis of suppliers and subcontractors is used to identify potential weak points linked to external processes, with the aim of guaranteeing the quality, safety and conformity of raw materials in the manufacture of pharma products.

Optimise your business with our specialist pharmaceutical manufacturing audits.

Plan your audit now!

COACHING FOR PHARMACEUTICAL MANUFACTURERS

COACHING FOR PROFESSIONALS IN THE PHARMACEUTICAL INDUSTRY

coaching CEO pharma

As experts in the requirements and obligations specific to the pharmaceutical sector, we provide support to players in the sector to help them overcome certain difficulties. Our specific coaching covers the areas inherent in quality and ANSM control points.

Make your mark with Lugan Consulting.

OUR DEDICATED SUPPORT

Audit des risques
Risk analysis approach
Accompagnement projet
Technical and organisational project support
Formulation des produits pharmaceutique
Support for the formulation of pharmaceutical products - Galenic expertise
Audit data integrity
Data integrity compliance

Transform your business with our
pharmaceutical strategy coaching.

Discover our solutions.

PHARMACEUTICAL TRAINING

IN-DEPTH STUDIES SPECIFIC TO PHARMACEUTICAL MANUFACTURING ​

Our training programmes dedicated to the cosmetics and pharmaceutical industries provide the knowledge, methodology and updates that are essential for setting up or maintaining a high-quality, standardised manufacturing process.

Acteurs de l'industrie pharmaceutique en formation.

Hone your expertise in pharmaceutical manufacturing!

OUR PHARMA TRAINING

Les BPF : savoir les respecter est le secret de la réussite des producteurs pharmaceutiques.

Good Manufacturing Practices

How can data integrity and security be guaranteed in a GMP environment? Assimilate the regulatory requirements applicable to your GMP environment in order to implement an effective system that complies with current regulations.

L'intégrité des données est la base de la sécurité et de la qualité d'une unité de fabrication pharma

Data integrity

This training course will give you a better understanding of the regulatory requirements applicable to your GMP environment, so that you can implement an effective system that complies with current regulations.

Analyse de risque dans l'industrie pharma

Risk analysis

Learn about the fundamental principles of risk analysis according to ICH Q9, and how they can be implemented within your company. Practise using these tools, with the help of case studies and exercises.

Conduite du changement

Change management

This course is designed for pharmaceutical industry professionals involved in change management, whether in production, quality or any other sector with an impact on product quality.

Human error

Identify the underlying causes of human error (psychological, organisational and environmental factors). Tackle tools and practices aimed at reducing these errors, thereby strengthening confidence in the manufacture and distribution of medicines.

Qualification and validation in the pharmaceutical industry

Explore the standards and regulations that guide these critical processes. Get the fundamentals to understand the requirements, best practices and challenges associated with qualification and validation.

Auditeur interne dans une usine de production pharmaceutique

Internal audit

Learn how to conduct an audit, from planning and preparation to the conduct and summary of the exercise. Review the regulations specific to the pharmaceutical industry, including the major role of the procedure in ensuring regulatory compliance and process quality.

Le knowledge-management pour aller toujurs plus haut

Knowledge management

Learn how to create a knowledge-sharing culture within your organisation, set up a high-performance information management system and harness this knowledge to stimulate innovation, improve decision-making and boost your company's competitiveness.

La lean management permet d'optimiser ses ressources

Continuous improvement and Lean management

The aim of this training course is to clarify the expectations and roles of the manager, to understand management styles and to identify the levers for improving team cohesion and fostering individual motivation.

méthodologie-résolution-problèmes

Problem-solving methodology

This course is designed to guide you through the essential stages of problem solving, providing you with the tools, techniques and approaches you need to identify, analyse and resolve your quality issues effectively.

Savoir répondre à une injonction ANSM

Preparation for ANSM inspection

Make sure you meet the inspection body's expectations with this specific support. Thanks to our method, learn how to present your company's activities and answer the inspectors' questions questions from the inspectors, while adopting an attitude suited to the context of a regulatory inspection.

Boost your performance with
our pharmaceutical training courses.

Take a look at our programmes!

PHARMACEUTICAL EXPERTISE WITH THE A3P NETWORK

NETWORK OF PLAYERS IN THE HEALTHCARE PRODUCT MANUFACTURING CHAIN

Réseau A3P : experts du secteur pharmaceutique

In addition to our experience at the heart of the pharmaceutical business, LUGAN CONSULTING is a member of the A3P network. The purpose of this association is to bring together professionals in the drug, cosmetics and bioproduction manufacturing chain. Together, we study the technological and regulatory requirements of the sector and share best practices.

Take advantage of the shared knowledge of the A3P network.

WHAT ARE THE CHALLENGES FACING THE PHARMACEUTICAL INDUSTRY?

A lack of responsiveness to changes in the sector, negligence in quality processes or failure to comply with regulations can be costly, both financially and in human terms, for manufacturers in the pharmaceutical market. Some of the most common causes of strategy failure are :

        • lack of innovation;

        • supply chain disruptions;

        • ANSM injunctions;

        • changes in structures as part of reindustrialisation.

           

BENEFITS OF AN EXTERNAL AUDIT

  • Industry best practice: compliance with standards;

  • Enhanced governance: informed decision-making;

  • Employee satisfaction: boosting team confidence;

  • Risk reduction: crisis prevention;

  • Adaptability to change: strategic alignment;

  • Improved performance: and competitiveness, creation of added value…

OUR FULL RANGE OF SKILLS

IS APPLICABLE TO ALL INDUSTRY SECTORS.

We offer a wide range of solutions to meet all your company’s requirements.
Make the most of our services by combining them in the right way.

conseil en stratégie d'entreprise

Audit

Have your structure and its organisation assessed, as well as your teams’ work processes and methodology. This is the first step in initiating a transformation.

coaching d'entreprise: fédérez autour d'un projet

Coaching

Bring about change gently with our coaching services. Our approach places the individual at the heart of the process and ensures the well-being of our teams.

Formations Lugan Consulting

TRAINING

Valorize your business by complementing our consulting and coaching services with training tailored to the needs and context of your organisation.

SYSTÈME QUALITÉ PHARMACEUTIQUE​

AUDIT – ACCOMPAGNEMENT – FORMATION –
INDUSTRIES PHARMACEUTIQUES ET COSMÉTIQUES