In addition the FDA also published a complimentary document in support of the original guidance. Though the FDA has not finalized this guidance it appears that the FDA is making moves to have it finalized but keeping it alive and supporting the initiative with other publications.
This particular guidance will have a dramatic impact on the industry in terms of submitting on a yearly basis metrics associated with each and every product manufactured by a firm. It is important to understand this guidance and begin preparations to meet the requirements associated with it.
Areas Covered in the Session:
An introduction into the requirements associated with the FDA draft guidance on Quality Metrics.
In addition a summarization of the independent surveys from industry organizations
The complimentary documents associated with quality metrics