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.
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 knowledge of the Guideline to understand the organizational gaps to be filled, in order to formulate an effective Transition Plan to the new Guideline
Learn how to focus validation efforts, by creating a culture of deeper process understanding that translates into a more focused validation effort
Learn how to use the updated Guideline to identify cost-saving opportunities within their organization, encouraging leaders to embrace the Guideline as a path toward good business practice
Who can Benefit
Anyone with Validation background in the Pharmaceutical and Medical Device Industries, Ranging from the experienced Validation Engineer, Validation Leaders, such as Managers, Directors, and up through Vice Presidents for QA/QC/Regulatory Affairs
Less-Experienced workers in the Medical Products Industries, as a means of gaining an appreciation for the regulations that guide procedures at the manufacturing facility.
For Registration-
http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500974?expDate=August26_2015_Annex15-Eudralex=Channel=printweek
Note : Use coupon code 1371 and get 10% off on Registration