FDA Inspection Readiness Certification

What Is the FDA Inspection Readiness Certification Program and Why Is It Needed?
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 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.

Who Will Benefit by the FDA Inspection Readiness Certification?
The FDA Inspection Readiness Certification will be valuable to all individuals working within or managing a manufacturing program that supports either the R&D development of a new drug product or the manufacture of commercial drug product released to the market. Obtaining the certification would be beneficial to professionals in:

  • Quality Control
  • Quality Assurance
  • Research & Development
  • Technical Operations
  • Contract Manufacturers
  • Manufacturing and Filling Operation
  • Regulatory affairs personnel as well as individuals who are responsible for the review or audit of such inspections and reports should likewise consider the value of this comprehensive certification in their positions.

    Who Is a Certified FDA Inspection Readiness Professional
    The Certified FDA Inspection Readiness Professional is an individual trained in effective and compliant manufacturing, quality and lab operations; exhibiting the techniques, tools and knowledge of FDA regulations sufficient to avoid non-compliance issues. The Certified FDA Inspection Readiness Master will be able to:

  • 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.
  • Benefits to the Candidate
    The FDA Inspection Readiness Certification recognizes that the Candidate has completed and demonstrated proficiency in each of the the required series of online courses. The distinction of a Certified FDA Inspection Readiness Professional can differentiate the candidate from others in their industry.

    The FDA Inspection Readiness Certification Program consists of 10 intensive, 90-minute courses, a total of 15 contact training hours. Candidates must complete and score at least 80% in the Learning Assessment* for each course.
    *Learning Assessment is a means of testing that will be administered as part of each course. This resource will be used to verify that mastery of the subject has been achieved.

    Simply sign up for one at a time or all the complete certification program Pre-enrollment savings when you enroll in the entire 10 course program.

    Courses included in the 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

  • These courses are available from time to time in live format and are subsequently available on demand for your convenience. Check the CfPA website for the next live presentation or register at any time for the on demand course.

    Courses within this or any CfPA Certification Program may be taken individually for further career advancement