FDA Inspection Readiness Certification

Register for CfPA's FDA Inspection Readiness Certification
Register for CfPA's FDA Inspection Readiness Certification
What Is an FDA Inspection Readiness Certification and Why Do I Need It?

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.

CfPA’s FDA Inspection Readiness Certification program provides the key principles and tools required to become an 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, like you, the proper training and skill development needed to attain their certificate of accomplishment.

Who Will Benefit by the FDA Inspection Readiness Certification?
The FDA Inspection Readiness Certification will be valuable to anyonethose 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:

  • Quality Control
  • Quality Assurance
  • Research & Development
  • Technical Operations
  • Contract Manufacturers
  • Manufacturing and Filling Operation
  • 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.

    Why become a Certified FDA Inspection Readiness Professional?
    The Certified FDA Inspection Readiness Professional is a person who has been trained in effective and compliant manufacturing, quality, and lab operations, as well as the techniques, tools, and knowledge of FDA regulations that are needed to avoid non-compliance issues.

    The Certified FDA Inspection Readiness Master will be able to do the following:

  • Develop Pre-planning and preparation activities.
  • Know what to do when the investigator arrives.
  • Know what documents to have ready and on hand.
  • Understand the quality systems that will be reviewed.
  • Develop assignments and responsibilities for the inspection.
  • Understand inspection Do's and Don'ts.
  • Develop solid and compliant responses to observations.

  • How to Earn Your FDA Inspection Readiness Certification?
    Becoming a candidate is easy.

    Enroll: Register for the complete 10 course program. You will receive an email with instructions on accessing the courses.

    Learn: Attend each of the 10 courses and successfully pass the self-assessment with a score of 80% or higher.

    Earn: Once you have fulfilled all the program requirements, you will receive a certificate recognizing your achievement.

    Register for CfPA's FDA Inspection Readiness Certification

    What courses are included in the FDA Inspection Readiness 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 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

  • Want to certify a group? Learn more about team certification by chatting with us now.