Skip to content. | Skip to navigation

News
>
Article | Important considerations to help successfully manage regulatory authority inspections from a CDMOs perspective

Article | Important considerations to help successfully manage regulatory authority inspections from a CDMOs perspective

Medium: Pharmaceutical Manufacturing
Author: Joachim del Boca, Vice President of Regulatory Affairs/Quality Compliance

An inspection from a regulatory authority need not be a daunting one. Practice and preparation will often make the difference between success and failure. But what are the pitfalls, challenges and obstacles that need to be incorporated into a plan to achieve compliance? Can a company increase its chances for success from the start? What are the key considerations that a CDMO must take into account to successfully manage a regulatory inspection?

When it comes to being prepared for an inspection from a regulatory authority, the combination of practice and preparation will often make the difference between success and failure. In Contract Development Manufacturing Organizations (CDMO), prioritizing the awareness of how to achieve a successful inspection can increase a company’s chances for success. What are the key success factors to be aware of and incorporate into your company to help ensure successful inspections? Can the challenges inherent in an inspection be reduced or even eliminated? How can a CDMO manage increased regulation and the growing number of inspections? Joachim del Boca, Vetter Vice President of Regulatory Affairs/Quality Compliance offers his thoughts and insights into these questions and more in May 2016 at Pharmaceutical Manufacturing.


To the full article
Important considerations to help successfully manage regulatory authority inspections from a CDMOs Perspective

Back to newsroom