Remediation
Serious problems can occur and it’s critical that you ensure you have properly managed the remediation of the problem. Often, an independent review of your systems and CAPA can be valuable. FAAUZ Pharma has extensive experience in responding to objectionable observations made by FDA through FDA-483 Notices of Objectionable Observations or Warning Letters. We can help you in designing responses, independent review and advice on how to design responses in line with regulatory expectations.
A gap analysis is a critical step in maintaining continuous compliance with regulatory or industrial standards. It can not only expedite the process of compliance with a new standard but can also save an organization a lot of expenses involved in failing an audit. In other words, a gap analysis helps the company to understand where it stands now, where it wants to be, and how to get there from a quality point of view. The key deliverable will be a detailed report that helps the company identify and remediate gaps between current practices and regulatory standards in its overall quality management system.
Receive a risk-based gap assessment, corrective action plans and ongoing implementation support. We also provide ongoing coaching and mentoring for team members at all levels to ensure your culture changes in a sustainable way.