Qualification and Validation regulations have changed in both Europe and USA in recent years. Many pharmaceutical companies and suppliers are still using methods and documentation from previous practice although a risk-based approach has become a regulatory expectation since years. Also many companies have very little integration between their activities, so the overall qualification and validation effort is complicated, expensive and time consuming. Only few companies have leverage their qualification and validation programs to a fully integrated approach, as the EU Annex 15 and the FDA Process Validation guide enables.
Qualification is an activity with a history of more than 20 years, but it is still hotly debated. Even modern approaches, aimed at time and cost optimization, do not seem to bring about the expected improvement. A non-harmonized terminology emerges as one of the main problems, especially when it comes to the integration of good engineering practice. An attempt to create clarity here could be a signpost for a future optimized approach. This attempt will be made in the context of this conference.
The Conference is also about time saving integrated qualification and validation activities. Suppliers are an important factor in this modern Approach.
A team of pharmaceutical companies, engineering companies and suppliers have further developed ECA`s Good Practice Guide “Modern Qualification” from the last years feedbacks from regulators, the pharmaceutical industry and suppliers are now integrated to improve the document to more needs of the users.. The revised guide “Integrated Qualification and Validation – a guide to effective qualification based on Customer – Supplier Partnership! will be presented in the final Version.
The team behind the draft guideline will be present. Participants will have the opportunity to review and discuss the contents and technical aspects of the guidance document, its scope and practical application and to discuss. All delegates will receive a copy of the guide free of charge. Case studies explain how to work together with suppliers and how to use an integrated approach.