Because of the importance and criticality of what we do, life science regulated manufacturers must be inspection ready at all times, aligning their organization with the expectations of regulating agencies. No matter the agency regulating you the same rules apply – you simply need to be ready and do the right things right.

Preparing for successful inspections is not a one-time event. Being inspection ready means that leaders are committed to managing compliance as an integral part of their company culture. Managing compliance is something that is done every day and not something simply done to prepare for an inspection by regulators.

When the FDA Inspectors are at your door you usually think first about meeting space, document availability, and the current condition of your plant and equipment. The real key concern is if your employees are prepared to participate in a comprehensive site inspection conducted by trained FDA investigators.

The issue is that the employees that know the most about your operations are usually the people who have the least experience with the inspection process and as a result are the most likely to create issues and problems as they respond to investigator inquiries.

The effective training of subject matter experts (SME) in terms of what they need to know and how they need to behave during an inspection deserves equal attention as that of operational matters such as equipment function, cleanliness and documentation.

The selection of SME’s – those that are selected to be the face of the organization – is also a key.  Your SMEs must possess several key factors that when honed will enable them to successfully weather the intensity of the FDA inspection.

Compliance readiness is a corporate cultural life-style that must be lived consistently to ensure positive readiness inspections outcomes.

Adverse findings during a FDA inspection depending on their severity can have catastrophic results to the company, the function targeted by the findings, and management.  Every associate within the organization is responsible for being compliant and having the skill and knowledge to properly interact with inspectors and manage the inspection process.

This 3-hour virtual seminar will walk-through every facet of the readiness inspection from your selection to be audited, through the process itself, to the handling the outcomes and everything in between. This seminar will identify those critical to compliance areas that must be properly addressed to ensure fully compliant and inspection ready operations