Live Online Conference on 16/17 November 2021

This year, like the last, is bound to have a lasting impact on us all. The Covid-19 pandemic is still shaping our professional environment as well as our private lives. But life goes on.

Therefore, the ECA has decided to offer this conference as a Live Online Conference once more.

Highlights:

  • Integrated Qualification and Validation acc. EU GMP Annex 15: Inspector´s View
  • Modern Qualification and Validation from an Ex-FDA perspective
  • ISPE Commissoning & Qualification Guide Version 2 (2019)
  • How suppliers work: Good Engineering Practice in Qualification
  • Cooperation between customers and suppliers on Integrated Qualification and Validation
  • Remote FAT/SAT – Tools possible not only in a pandemic situation
  • ECA Q&V Guide and tools: Risk-based qualification from URS to PQ
  • ECA Q&V Case Study: Fast and effective project execution with suppliers
  • Supplier Contracts during Qualification
  • Case Study Influence of pharmaceutical QA during renovation and new buildings
  • Electronic Documentation in Qualification projects – new Appendix
  • Equipment Categorization – a tool to streamline qualification

Objectives:

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/commissioning activities. 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 version 1.0 of  ECA`s Good Practice Guide “Integrated Qualification and Validation – a guide to effective qualification based on Customer – Supplier Partnership” to a 2.0 version. It now includes feedback from regulators, the pharmaceutical industry and suppliers to improve the version 1.0 from last year to better fit the needs of its users. The revised guide version 2.0 will contain new appendices about critical aspects risk assessments (CARA), remote FAT/SAT, equipment categorization and about contracting qualification activities. The electronic documentation appendix has been revised as well as the main text of the document.

The speakers are team members or reviewers of the guide So you have the opportunity to discuss the contents, technical aspects of the guidance document, its scope and practical application during Q&A sesssions. All delegates will receive a copy of version 2.0 free of charge as download. Case studies explain how to work together with suppliers and how to use an integrated approach.

Background:

Qualification of equipment and validation has been mandatory since the late 80s (FDA Guideline on Process Validation) and the early 90s (EU GMP Guide). Due to inspection results at that time, qualification activities increased significantly and very often, the focus on the patient was lost. The original purpose behind qualification, which is to show that equipment is fit for its intended use, was lost. A white paper from the ISPE “Risk-based qualification for the 21st century tried to amend this. With reference to this paper, ECA´s Validation Group has now further developed a Good Practice Guide on Modern Qualification to Integrated Qualification and Validation.  This guide is supposed to assist pharmaceutical companies and suppliers with how to qualify equipment in a lean way and how to integrate the qualification into validation. Like in the GAMP-Guide, examples build the core of this further developed Good Practice Guide on Integrated Qualification and Validation.