Lugan Consulting

CONSULTING, AUDIT AND TRAINING -
PHARMACEUTICAL AND COSMETIC INDUSTRIES

Specialist in the pharmaceutical and cosmetic industries, we support you in your transformation and optimization projects

Consulting & Audit

We are a specialized consulting and training firm for the drug industries.

Our expertise:

GMP training

Pharmaceutical Quality System (ICH Q10)

How to successfully implement a pharmaceutical quality system (ICH Q10)?

Objectives:

  • Understand Regulatory Requirements (GMP – ICH Q10)

  • Establish a strategy for implementing a pharmaceutical quality approach within your institution

  • Identify the action levers for an effective and sustainable implementation

good manufacturing practices

How to implement Good Manufacturing Practices in a GMP environment? How to ensure compliance of pharmaceutical operations in a GMP environment?

Objectives:

  • Identify the risks applicable to your department’s activities

  • Apply GMP rules within your entity

  • Understand everyone’s responsibilities in implementing GMP requirements

Data Integrity in the Pharmaceutical Industry

How to ensure data integrity in a GMP environment? What requirements should be implemented?

Objectives:

  • Understand data integrity requirements

  • Understand and apply data integrity criteria (ALCOA principle)

  • Federate its teams around “Data Integrity”

Change management - Change control

How to implement an effective change management approach in a GMP environment?

Objectives:

  • Understand change management expectations

  • Implement an effective management system

  • Define the governance associated with this approach

Management of deviations

How to treat deviations effectively? Method and tools for an efficient and optimal quality approach

Objectives:

  • understand regulatory requirements

  • Optimize the deviation process

  • Use tools appropriately

CAPA Management

How to implement an efficient CAPA management system? Which strategy to implement?

Objectives:

  • Understand regulatory requirements

  • Define an optimal system for CAPA management

Focus Areas

accompagnement-conseil-et-formation
LUGAN AUDIT

Audit and consulting

maintenance
LUGAN COACHING

Coaching

formations
LUGAN FORMATION

Training

the opinions of our customers

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Thank you for your support. I feel much better and can therefore approach the future more serenely. I realize that this coaching has been very beneficial to me both professionally and personally.

Delphine

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Complete and customized training. Interactive and dynamic presentations adapted to our organization and our problems. Enriched by the experiences of the trainer and captivating anecdotes, they allow the topics discussed to become concrete and transposable.

Auditeur AQ

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Pragmatic, operational and synthetic approach.

Resp. Qualité