The GDP Compliance Manager

The GDP Compliance Manager

Berlin, Germany

Course No 15638


Costs

This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Heike Gottschalg, Boehringer Ingelheim, Germany

Dr Afshin Hosseiny, Chairman of the ECA GDP Association

Alfred Hunt, form. Irish Health Products Regulatory Authority (HPRA) and key member of the EMA drafting group for the revised EU-GDP Guidelines

Savvas Koulouridas, Fagron Hellas, Greece

Robert Müller, Boehringer Ingelheim, Germany

Rico Schulze, GMP/GDP Inspectorate, Germany

Objectives

This education course provides practical guidance through workshops on how to perform gap analysis, prepare plans for implementing systems and procedures to bring your organisation in compliance with the GDP regulations.

Background

The globalisation of the pharmaceutical supply chain has created new challenges for manufacture and supply of medicinal products in various markets, resulting in reduced control and increased security risk to the products.

The EU-GDP Guidelines have been extensively revised to take into account the changing nature of the globalised supply chain. The new requirements have been effective since 2013. These requirements highlight the need for an effective quality management system supported by risk assessment and appropriate controls.

This three day tutorial has been designed to bring you up-to-date with the current regulatory expectations and standards for Good Distribution Practice (GDP) and to provide you with tools and guidance to help you with identifying the gaps in your quality systems compared to the new requirements and planning and implementing the actions required.

Target Group

Managers and executives from companies involved in the distribution and supply of pharmaceutical products.

Programme

The Inspector’s Point of View

  • The new GDP Guidelines: What is it all about?
  • Background to development and revision of the new EU GDP Guidelines
  • Well-known or new: A summary of the most important changes
  • A look into the crystal ball: What is the impact on industry and other stakeholders?
GDP Inspection Findings and what to learn from them
  • Findings and their ratings
  • Examples from manufacturers, wholesalers, storage facilities and transport deviations
Workshops and interactive Sessions

Quality Management System (QMS)
  • What is a QMS and why do we need it?
  • What does an effective QMS look like?
  • How to develop and implement an effective QMS
Transportation
  • Key requirements for transportation of medicines
  • How to develop and implement a GDP-compliant and cost effective transportation network.
Premises & Equipment
  • What is a must for medicinal products
  • How to plan and implement facility improvement ensuring compliance with the current requirements
Operations
  • Qualification of suppliers and customers
  • Receipt, storage and return of medicinal products
  • Deviation and Complaint Management in a wholesaler facility
  • How to conduct a gap analysis, develop plans and implement the new requirements
Personnel
  • Competency requirements for GDP personnel
  • Overview of the role and responsibilities of the Responsible Person
  • Necessary documentation
  • Training matrix and managing continuous training
Outsourced Activities
  • What is an outsourced activity?
  • How to set priorities to audit, approve and manage service providers
  • How to develop and manage contracts and agreements
Contracts in the global Supply Chain
  • International laws and systems – how they work and fit together
  • Jurisdictions and conflict of law provisions
  • Contract law, Technical/ Quality Agreement, Supply Agreement
  • 3PL Providers: two bilateral agreements or one tripartite agreement?
  • When things go wrong
Lessons learned and Action Planning

Case Study for a successful Implementation
  • Approach
  • How we approached the new requirements
  • Challenges and best practice
Summary and Take Away Message
  • Developing a take home action plan for the delegates

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