FDA Inspection Readiness Certification

FDA INSPECTION READINESS PROFESSIONAL CERTIFICATION FULL 10 COURSE PROGRAM

Take advantage of pre-enrollment savings by registering for the ENTIRE 10 COURSE program now, only $2050. No application process or additional fees. 

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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.

Our 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.

Required Series of Online courses:

• 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 Investigation 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