Track 1 - Qualification, validation, statistical process control and industrial performance

MASTER CLASS MAGHREB PHARMA 2023

Wednesday, February 8, 2023

Track 1 - Qualification, validation, statistical process control and industrial performance

Mr. Pierre DEVAUX Director of Theraxel and Isotec’xel

09h00 – 10h30

Topic: “Overview New Annex 1 of the European GMPs: Key issues and the link with the concepts of Control and Monitoring for manufacturing sites of sterile and related products”.

Cette présentation se veut une vision très pratique de l’Annexe 1 en y incluant les attentes des Autorités de Santé en décrivant le processus de révision qui l’a accompagné. Au-delà de cette présentation, il sera bien évidemment possible d’échanger sur l’ensemble du document. Cette présentation apportera notamment du conseil sur l’élaboration de votre CCS, nouveau document exigé par les Autorités de Santé européennes.

Mr. Jean-Louis JOUVE President and owner of COETIC SAS

10h45 – 12h15

Topic : “CSV: Validation of Computerised Systems in the Pharmaceutical Industry.

The requirement for validation of computerised systems is widely known, but how can this validation be implemented effectively and efficiently, taking into account the multiplicity of systems, suppliers, available documentation and changing technologies? Can new approaches such as Computer Software Assurance (CSA) help industry?

PharmD Malik METAHRI Managing Director & Senior Partner, ACG – Accelerator Consulting Group (Europe & Middle East) | President of A3P Egypt & Middle East

13h30 – 14h30

Topic : ” EMA and FDA certification: Strategy and standards for preparing and managing regulatory inspections “

Abstract coming soon

Ms. Nassima HAMDI Founder and General Manager of WANYLAB

14h15 – 15h15

Topic “APR: A regulatory tool for monitoring process performance”

The pharmaceutical industry is an industry subject to intensified and constantly updated quality and regulatory requirements. This rigour in the production of pharmaceutical products has made it possible to master the pharmaceutical processes. As a result, a summary report is produced annually for each product placed on the market, known as the Annual Product Quality Review (APQR). Indeed, the APQR is much more than a simple response to regulatory requirements but a major process in the improvement of product and process quality. It is a real tool of the quality management system and is an indispensable element within a pharmaceutical company. It is a tool for monitoring the quality of products over the years, which ensures the control of the manufacturing process by following trends, anticipating deviations, and evaluating the specifications, the manufacturing method, and the control of the product on the one hand, and on the other hand, to highlight failures in the system in order to allow an annual evaluation of its level of efficiency and performance.

Dr. Rachid BERKANI Expert Consultant in Industrial Performance Master Black Belt and Lean Six Sigma Trainer

16h00 – 17h00

Topic : “Implementation of the visual performance management system”

Industrial performance is a major objective of any company, the declination of strategic objectives into a performance management system and its implementation down to the shop floor level is based on management components such as – The implementation of the industrial KPI system – Visual performance management – Short interval animation and the Daily management system – Structured problem solving system. In this paper, the different components of this system will be discussed, as well as the steps to implement the system and the key success factors of this system. The benefits of our joint approach : – Ritualised performance management with a system of escalations – Standardisation of practices for all managers – Easier reporting and transmission of problems in the field – Prioritisation and follow-up of actions generated – Empowerment of employees thanks to an integrated “problem-solving” application aid.

Dr. Nazim BERERHI Consultant, Trainer, Auditor on ISO 9001 standard

17h15 – 18h15

Topic : “Management system: how to prepare and conduct a management review”.

In a world where the stakes are constantly changing, and which impact the operation, performance and sustainability of the company. ISO 9001 provides companies with a quality management system, with the objective of ensuring the conformity of products to legal requirements but also to increase customer satisfaction. Through the development of the risk approach, continuous improvement and the process approach, ISO 9001 enables the various risks and opportunities to be controlled and added value to be created in all processes in order to achieve the objectives. To this end, management must review the entire system, its operation, its performance, its results and the various feedbacks at planned intervals through the management review, In our workshop, we will develop the different aspects of this review, the methods of data collection, consolidation and analysis of information, but also how to define the most interesting interval for a good exploitation of this review as a tool for improving the system and the objectives. More than just inputs, the management review will allow, through the development of a factual and methodical approach, to make the right decisions and to determine the resource needs and opportunities for improvement.

MASTER CLASS MAGHREB PHARMA 2023

Wednesday, February 8, 2023

Track 1 - Qualification, validation, statistical process control and industrial performance

The event starts in :

MAGHREB PHARMA Expo

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