The New Validation Paradigm-Annex 15 Eudralex Volume 4 2015

The New Validation Paradigm: Are you Ready for Annex 15 Eudralex Volume 4: On the 1st of October? Instructor: Regina Fullin Product ID: 500974 Description Annex 15 of the European Commission (Eudralex) Volume 4 on Qualification and Validation has undergone a significant rewrite, effective on October 1, 2015. At a high level, this standard takes into account other sections of the standard and accounts for changes in manufacturing technology for medicinal products, including global harmonization efforts. With only one month left to comply with this standard, the thrust of the discussion will detail the required changes for a facility that is already in compliance with the current standard, and will discuss how these changes can translate into business-transforming opportunities for cost-saving improvements. Areas Covered Additions to the Guidance Areas where the Guidance provide additional flexibility Areas where the Guidance provide additional detail The major paradigm shifts contributing to the above areas, including relationship to harmonization How these paradigm shifts may change the way your organization does business How incorporating the changes in the Guidance can be used as a way to improve business What you can do to prepare for the changes now Why Should you Attend Trainees should attend this Webinar to gain an understanding of the “Why” behind the “What” in the revised regulation so they can implement meaningful changes to their company’s validation program that meet the intent of the Guideline. This will help create the necessary cultural shift to facilitate improved business performance that transcends mere compliance to the Guideline. Objectives of the Presentation Recall the regulatory requirements of the past, and compare them to the new practice Identify the major paradigm shifts in industry that are addressed by the revised Guideline Understand the cultural shifts in the industry that contributed to the need for an updated Guideline Gain sufficient