Mock-Up FDA Audits
Medical device, In Vitro Diagnostics (IVD), and other drug-related manufacturers can hire us to do mock FDA audits. In fact, our AP FDA Consulting lead consultant has extensive knowledge of the US Federal Food, Drug, and Cosmetic Act (FD&C Act) and related laws. Furthermore, this expertise and understanding of FDA-related laws, regulations, and compliance policies has been acquired through various positions, training, and experiences. He began at the US Federal Food and Drug Administration (US FDA) field office as a chemist, then worked as an FDA Field Office Medical Device Investigator, and then as a Compliance Officer. He has also served as a national authority on unapproved new drugs and has been part of a foreign inspection cadre as well as a Supervisory Investigator. In these capacities, he supervised medical device and drug investigators.
So let an expert with an in-depth background at the FDA help you with mock FDA audits. If your consultant has never worked for the FDA, he or she may not be in a position to perform mock FDA inspections. Our lead consultant has a total of 30 years with FDA inspections, combining 16 years at the FDA itself and 16 years as an FDA consultant and auditor.
Mock FDA Audit
Why bother getting a mock FDA audit? If you are a medical device or pharmaceutical drug company executive, you should consider having an FDA mock inspection. To assure that your quality and manufacturing facilities conduct their operations in compliance with the law. In addition, several conditions at your company might further encourage you to get an FDA mock inspection.
Why Mock FDA Audit
- Firstly, if your noncompliance is more than acceptable or if you have out-of-specification products but are unsure about how to correct those problems;
- Secondly, if your company implemented or underwent a significant change to your quality policy manual;
- Thirdly, if you have hired a new quality department head or quality personnel;
- Fourthly, if you have launched a new product but have never been inspected by the United States Food and Drug Administration (US FDA); or
- Finally, if you have an unusual number of consumer complaints, Medical Device Reporting (MDR) reportable events, or product market removal or correction incidents.
With 30 years of combined FDA and industry experience
We are in a much better position to conduct a mock FDA audit than consultants without such experience. Furthermore, we know both sides of the story, and we bring both sides to the table. After 4 or 5 days of onsite mock FDA inspection, our auditor can answer most, if not all, of your questions about your company and the state of its compliance with FDA laws and regulations. Our former FDA investigator can conduct any type of FDA mock inspections, including for QSRs, pre-market approval, post-market approval, in vitro diagnostics (IVD), design controls, sterilization validation, and production and process controls (P&PC). Moreover, we can use the Quality System Inspection Technique (QSIT) method and indicate corrective and preventive actions (CAPA).
Please don’t wait until a problem emerges because, at that time, it may be too late to correct. Mock FDA inspections are not quick fixes but part of long-term plans for compliance with the law. Whether you are located in Australia, Switzerland, Germany, France, Ireland, United Kingdom (UK), Denmark, Finland, Japan, South Korea, Italy, China, or anywhere else in the world, we will travel to your facility. Finally, on the last day of the mock FDA audit, we will discuss major to minor concerns with you, as well as offer suggestions for resolving each identified problem. Please find out how you can benefit from our FDA mock inspection.
QSIT Mock FDA Audits
When conducting mock FDA inspections for a medical device manufacturer, our consultant will follow Guide to Inspections of Quality Systems (QSIT) technique, covering the following subsystems
- Design Controls
- Corrective and Preventive Actions (CAPA)
- Production and Process Controls (P&PC)
- Facility & Equipment Controls
- Material Controls
- Records, Documents Change Control
- Plus Medical Reporting Regulations (MDR), Reports of Corrections and Removals, and Medical Device Tracking.
The QSIT technique for performing mock FDA audits is based on a “top-down” approach to provide you the key objectives that can determine your state of compliance. You will not get any more “real world” mock FDA inspections.
As a guide to mock FDA audits of drug manufacturers to determine the compliance with the drug CGMPs, our inspection is based on IOM (Investigations Operations Manual), for example:
- Bulk Pharmaceutical and Raw Materials
- WFI and High Purified Water Systems
- Cleanroom Validation
- Process Validation
- Sterilization Validation
- Computer and Software Validations
- Cleanroom Validation
- Cleaning Process
- Environmental Monitoring
- Lyophilization Process
- Media Fills
- Quality Control and Microbiological Laboratories
- DMR and DHR Batch Review