spacer
home > white papers > Risk-Based Inspection Readiness: Reducing Headaches with Advanced Preparation - The Avoca Group
WHITE PAPERS
logo_The_Avoca_.jpg

The Avoca Group

phone (609) 252-9020
web http://theavocagroup.com/
email 179 Nassau St., Suite 3A, Princeton, NJ 08542

Risk-Based Inspection Readiness: Reducing Headaches with Advanced Preparation

So often, inspections are a major source of stress in the clinical trial environment. This is especially true when processes involved in preparing for an inspection are reactive. But, it doesn’t have to be that way. Using industry-leading practices and resources enables a proactive approach to mitigate—or even eliminate—the pain points associated with preparing for inspections.

The term “risk-based approach” encompasses all activities related to risk-based quality management (RBQM). RBQM is defined as a “systematic process put in place to identify, assess, control, communicate, and review the risks associated with the clinical trial during its lifecycle.


Risk-Based Inspection Readiness: Reducing Headaches with Advanced Preparation
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

3P Biopharmaceuticals renews its “Credit Impôt Recherche” (CIR) by the French Ministry of Higher Education and Research

[Noáin, April 22, 2020] 3P Biopharmaceuticals, a European leading Contract Development and Manufacturing Organization (CDMO) specialized in process development and cGMP manufacturing of biologics, has successfully extended its French CIR certificate for another four-year period: 2020-2024.
More info >>


White Papers

Crunch Time: The Impact of Serialisation Requirements on Packaging Operations

PCI Pharma Services

The deadlines for including unique product identifiers on prescription drugs is putting a strain on multiple parts of the industry, much of which is ill-prepared to meet the target. Here, we look to the experience of a company that is ahead of the curve for lessons on how to manage and ease the transition to serialisation.
More info >>


Industry Events

Outsourcing in Clinical Trials Europe

26-27 October 2020, Paris, France

Arena International are delighted to announce the return of Outsourcing in Clinical Trials Europe. Part of our global series of events, this flagship show will attract the leading clinical professionals from across Europe. The 10th Annual event will be hosted in Paris.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement