Many talk about QRM but do not necessarily mean the same thing. The confusion is getting worse as commonly used terms such as “risk”, “compliance risk”, CAPA (Corrective and Preventive Action), etc. have different meanings when used in different organisations or by different people. To ensure the effectiveness of the training, it is essential that concepts taught and terminology used reflect industry standard.
Widler & Schiemann have developed and taught a Training Program for neutral and independent associations such as –the Metrics Champion Consortium (MCC) and the Drug Information Association (DIA) that guarantees that content of training reflects current thinking of industry peers and regulators.
How can Widler & Schiemann assist you with your training needs on GCP, Quality Risk Management and other Quality Methodologies?
We are proud to be able to offer you tailored in-house training courses for your staff, either as refresher training or for newcomers. The first module is a general GCP training program that contains all current elements of GCP and shows, with examples, how it is applied in a Quality by Design (QbD) context. The second module is a QRM training module that enables trainees to understand the principles of a QRM approach including the necessary methodologies. This program is delivered publicly through DIA and the MCC. Last but not least we provide training on Quality Methodologies relating to GCP and Pharmacovigilance, such as training for auditors. Widler & Schiemann will work with your experts and process owners to define and agree on the best training approach and tailor it to the needs of your organisation.
