Agenda

Trends and Key Issues in the Pharmaceutical Industry

Tendencias y claves en laSTRIA FARMACÉUTICA: QUALITY BY DESIGN, VALIDACIÓN DE PROCESO DE FABRICACIÓN Y ANEXO I

Date

1 June 2023

Venue

Vitoria-Gasteiz

Time

9:15 am - 4:00 pm

Price

Free

Trends and Key Issues in the Pharmaceutical Industry; Quality By Design, Manufacturing Process Validation and Annex I

Optimisation of the manufacturing process validation process, and compliance with Annex I are essential for the development and manufacturing of safe and effective drugs. Current trends in the pharmaceutical industry include the application of advanced technology and process optimisation to reduce development, scale-up and manufacturing risks and optimise costs at all stages of generation and production of new pharmaceutical products.

  • Quality by Design (QbD) is a systematic and scientific approach to process design and development that ensures the quality of pharmaceutical products. This approach involves the use of statistical and scientific tools to understand and control the critical process factors that affect the quality of the final product.
  • The validation of the manufacturing process is a critical stage in any pharmaceutical development and is the link between the research of the product and its industrial manufacturing process, thus marking and defining crucial aspects for registration and for future manufacturing on a commercial scale. The optimisation of this process is increasingly becoming a tool to reduce risks and improve manufacturing stages and processes.
  • Annex I of the Good Manufacturing Practices (GMP) is a guide that sets out the quality and safety requirements for the manufacturing of sterile products. Much of the guidance in this guide, however, can also be applied to processes and facilities outside the field of sterile products. Their interpretation and correct application is a critical issue for pharmaceutical manufacturers.

Target Audience

This conference gives an overview of Quality by Design and its applications in galenic and analytical development, followed by an overview of the optimisation and validation of manufacturing processes, as well as an insight into the highlights of Annex I on manufacturing.

These issues have a relevant impact on the daily activities of the R&D, quality (control and assurance) and manufacturing departments.

Further information

  • Free access to the event with accreditation
  • Limited capacity
  • Legal Policies. Data shared by the two organisers of the event.

ORGANISERS

LogotipoTRESCAL
Logo TECNALIA

Parque Tecnológico de Álava, Leonardo Da Vinci 11, Miñano, Vitoria-Gasteiz

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Agenda

Time

ACtivity

Speaker

9:15 am - 9:45 am

Attendee Registration

9:45 am - 10:00 am

Welcome and introduction

Francisco Ledo. Business Development Manager. Pharma Lab. TECNALIA / Valentín Martínez. Sales Manager. TRESCAL

10:00 am - 11:00 am

QbD/PAT: Regulatory flexibility and efficiency at a pharmaceutical plant

Alicia Tebar. Founder and Consultant. QbD PHARMACEUTICAL SERVICES

11:00 am - 11:45 am

QbD applied to Analytical Development: New approach to ICH Q2R2 validation

Alicia Tebar. Founder and Consultant. QbD PHARMACEUTICAL SERVICES

11:45 am - 12:15 pm

Coffee break

12:15 pm - 1:15 pm

New Process Validation Strategy. Application to Product Life Cycle. Process Design / Process Qualification / Ongoing Process Verification

Fernando Tazón. CEO. Grupo ASINFARMA

1:15 pm - 2:15 pm

Most relevant technical innovations in the new Annex I

Roberto Español. Technical Manager Life Science. TRESCAL Pharma

2:15 pm - 3:00 pm

Lunch

3:00 pm - 4:00 pm

Pharmaceutical Development at TECNALIA Pharma Lab Services: Visit to the facilities / Visit to the manufacturing plant: Laboratorium Sanitatis SLU by TECNALIA

Eider Larrarte. Director of Pharma Lab Services. TECNALIA