MSL role responsibilities

The MSL role responsibilities are very specific that you must be prepared to meet those responsibilities.  FDA looks beyond employee training records during inspections as one FDA investigator states.

Be prepared: FDA looks beyond employee training records during inspections as one FDA investigator states.

Are employees suited for their particular position within the organization. Inspectors are looking at the necessary background, the right training, and the right experience levels to do the job functions they are performing. The Gray Sheet, September the 14th.

As an MSL or an MSL leader it is more important to be ready for your role. I can’t emphasis the importance of participating in a certificate led educational MSL program. After the training you need to place the certificates in your HR file. The organization should place requirements on the role or roles, If you lead a team of MSL’s you should at least have one year in the field as an MSL with the credentials set by your organization.