Modern Approaches to Qualification and Validation

The "Good Practice Guide Integrated Qualification and Validation" published last year by the ECA in version 2.2 is currently being put to the test in many practical applications. The aim is to adapt the Guide even better to the needs of users. In order to discuss the comments from the perspective of industry and authorities and thus to advance the development of the Guidance, the live online conference "Qualification and Validation Forum" on November 14 and 15, 2023, is to make a contribution.

The qualification of buildings and equipment has been an integral part of the development, manufacture and distribution of life science products for several decades. These products are active ingredients and pharmaceutical products as well as medical technology and cosmetic applications that are used in or on the human body in some way.

As Chairman of the Validation Group, Ralf Gengenbach, Managing Director of gempex GmbH, is responsible, together with its members, for the practical advancement of the Good Practice Guide “Integrated Qualification and Validation”.

The Event

The event is aimed at all those whose daily work in qualification and process validation is influenced by the revision of Annex 15 and the FDA guideline on process validation. And to all those who would like to learn how an integrated approach to qualification and validation can bring success to everyday project and process work through efficiency.

Topics such as ECA Good Practice Guide in relation to Annex 15, GMP Equipment Design, Equipment Categorization, Critical Aspects Risk Assessment, eValidation, paperless validation and qualification as well as a Case Study on customer-supplier cooperation are highlights on the agenda.

The speakers of the event are members of the team of authors or reviewers of the ECA Guideline who will take part in the discussion. Thus, the content of the guideline, technical aspects, scope of application and questions of practice can be discussed during the Q&A sessions.

gempex Expertise in Presentation

Ralf Gengenbach will act as moderator and provide an introduction to the concept of Integrated Qualification and Validation in the opening presentation. Feedback on the Integrated Qualification and Validation Guide will be presented, open questions will be discussed and finally an outlook on the advancement of the Guidline will be given.

Practical Benefit for the Participants

Participants will meet those who have contributed their experience and knowlege to the Guideline during its long development. They will meet representatives of authorities who have experienced and evaluated the implementation in inspections, planners and consultants who intensively accompany their customers in the development of inspection capable systems, and operators who are ultimately responsible for efficiency and reliability. An extremely interesting forum for questions and answers.

More information and a registration option are provided in the program for the event.

Ralf Gengenbach will be happy to discuss the topic of "Integrated qualification and validation" via