The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if you want an inspection that results in a satisfactory report. Many times, the arrival of a Regulatory Investigator is a daunting experience for some. This is why it is important to learn how to properly alert key members that an investigator has arrived, the proper protocol for setting up the Inspection room and any associated war rooms that will support the inspection, and how to manage requests from the investigators in a timely and accurate manner. This preparation minimizes stress and disorder during the inspections.
Working in a highly regulated industry, we know our firms need to be inspection-ready at all times. This is not only to maintain a good rapport with the Regulators, but also as a commitment to quality for our customers, the patients who use the products.
Regulatory inspections should be a time to demonstrate the high level of compliance your firm has committed to the regulations, and to customer safety and quality.
Cobblestone’s 10-Part FDA Inspection Readiness Certification program provides the key principals and tools required to become a FDA Inspection Professional. It is designed to provide rules, tools and techniques for effective and compliant management of FDA Regulatory Inspections. This FDA Inspection Readiness Certification Program offers professionals the proper training and skill development needed to attain their certificate of accomplishment.
Upon completion of this Certification, you will be able to:
Courses Included in this Certification:
Implementing a Change Control Quality System Successfully
Applying Quality Risk Management
CAPA: Definition, Plan and Program
Data Integrity
Complaint Handling Requirements (US)
Best Practices for Investigating Deviations and Non-Conformances
FDA Case Scenarios: Best Practices for Managing Inspection Situations
Conducting Successful Quality Audits
Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations
Managing Effective Regulatory Inspections and 483 Responses
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The FDA Inspection Readiness Certification will be valuable to professionals working in or managing a manufacturing program that supports either the R&D development of a new drug product or the manufacture of a commercial drug product that has been released to the market.
Professionals in the following fields would benefit from obtaining the certification:
People who work in regulatory affairs or oversee reviewing or auditing these inspections and reports should also think about the value of this comprehensive certification in their jobs.
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
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